phone (617) 481-4020
mail [email protected]
Contact
left-arrowBack to search

Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial

Clinicaltrials.gov ID: NCT04513717
db-list-check Status RECRUITING
b-loader Phase PHASE3
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 2478

Conditions

Metastatic Malignant Neoplasm in the Bone, Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8

Drugs

Apalutamide, Bicalutamide, Buserelin, Degarelix, Flutamide, Goserelin, Histrelin, Leuprolide, Triptorelin

Summary

This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine whether men with National Comprehensive Cancer Network (NCCN) high risk prostate cancer who are in the lower 2/3 of Decipher genomic risk (=< 0.85) can be treated with 12 months androgen deprivation therapy (ADT) plus radiation therapy (RT) instead of 24 months ADT+RT and experience non-inferior metastasis-free survival. (De-intensification study) II. To determine whether men with NCCN high risk prostate cancer who are in the upper 1/3 of Decipher genomic risk (> 0.85) or have node-positive disease by conventional imaging (magnetic resonance imaging [MRI] or computed tomography [CT] scan) will have a superior metastasis-free survival (MFS) through treatment intensification with apalutamide added to the standard of RT plus 24 month ADT. (Intensification study)

SECONDARY OBJECTIVES:

I. To compare overall survival (OS) between the standard of care (RT plus 24 months of ADT) and either the de-intensification (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies) II. To compare time to prostate specific antigen (PSA) failure or start of salvage treatment between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies) III. To compare PSA failure-free survival with non-castrate testosterone and no additional therapies between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies) IV. To compare MFS judged based on either standard or molecular imaging between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies) V. To compare prostate cancer-specific mortality between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies) VI. To compare testosterone levels at the time of PSA failure and metastases between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies) VII. To compare time to testosterone recovery (defined as a T > 200) between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies) VIII. To compare adverse events, both clinician-reported using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 and patient-reported using Patient Reported Outcome (PRO)-CTCAE items, between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies)

EXPLORATORY OBJECTIVES:

I. To compare changes in cardio-metabolic markers, including body mass index, and waist circumference, between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies) II. To determine a machine learning/artificial intelligence algorithm for radiotherapy quality assurance. (De-intensification and Intensification studies) III. To perform future translational correlative studies using biological and imaging data. (De-intensification and intensification studies) IV. Impact of PET use in high-risk prostate cancer

PATIENT-REPORTED OUTCOMES OBJECTIVES:

PRIMARY OBJECTIVES:

I. To compare sexual and hormonal function related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 24 months of ADT) and the de-intensification arm (RT plus 12 months of ADT). (De-Intensification Study) II. To compare fatigue, as measured by the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue instrument, between the standard of care (RT plus 24 months of ADT) and the intensification arm (RT plus 24 months of ADT plus apalutamide). (Intensification Study)

SECONDARY OBJECTIVES:

I. To compare depression, as measured by the PROMIS-depression, between the standard of care (RT plus 24 months of ADT) and the de-intensification arm (RT plus 12 months of ADT). (De-Intensification Study) II. To compare depression, as measured by the PROMIS-depression, between the standard of care (RT plus 24 months of ADT) and the intensification arm (RT plus 24 months of ADT plus apalutamide). (Intensification Study)

EXPLORATORY OBJECTIVES:

I. To compare cognition, as measured by the Functional Assessment of Chronic Illness Therapy-Cognitive (FACT-Cog) perceived cognitive abilities subscale, between the standard of care (RT plus 24 months of ADT) and the de-intensification arm (RT plus 12 months of ADT). (De-Intensification Study) II. To compare bowel and urinary function related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 24 months of ADT) and the de-intensification arm (RT plus 12 months of ADT). (De-Intensification Study) III. To compare fatigue, as measured by the PROMIS-Fatigue instrument, between the standard of care (RT plus 24 months of ADT) and the de-intensification arm (RT plus 12 months of ADT). (De-Intensification Study) IV. To compare sexual and hormonal function related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 24 months of ADT) and the intensification arm (RT plus 24 months of ADT plus apalutamide). (Intensification Study) V. To compare bowel and urinary function related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 24 months of ADT) and the intensification arm (RT plus 24 months of ADT plus apalutamide). (Intensification Study) VI. To compare cognition, as measured by the Functional Assessment of Chronic Illness Therapy-Cognitive (FACT-Cog) perceived cognitive abilities subscale, between the standard of care (RT plus 24 months of ADT) and the intensification arm (RT plus 24 months of ADT plus apalutamide). (Intensification Study)

OUTLINE: Patients are randomized to 1 of 4 arms.

DE-INTENSIFICATION STUDY (DECIPHER SCORE =< 0.85):ARM I: Patients undergo radiation therapy (RT) over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin and bicalutamide or flutamide) for 24 months in the absence of disease progression or unacceptable toxicity.ARM II: Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin and bicalutamide or flutamide) for 12 months in the absence of disease progression or unacceptable toxicity.INTENSIFICATION STUDY (DECIPHER SCORE > 0.85 OR NODE POSITIVE):

ARM III: Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin and bicalutamide or flutamide) for 24 months in the absence of disease progression or unacceptable toxicity.

ARM IV: Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin) for 24 months in the absence of disease progression or unacceptable toxicity. Patients also receive apalutamide orally (PO) once daily (QD). Treatment repeats every 90 days for up to 8 cycles (24 months) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up annually.

Locations

450 locations Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 480-922-4600

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 623-773-2873

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 480-922-4600

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 501-686-8274

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 661-323-4673

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 877-642-4691

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 510-745-6433

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 415-925-7325

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 877-467-3411

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 310-423-8965

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 530-749-4400

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 707-521-3830

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 714-734-6220

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 916-734-3089

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 818-981-3818

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 310-517-4665

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 530-582-6450

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 925-941-4246

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 720-848-0650

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 719-365-2406

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 719-364-6700

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 970-569-7429

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 970-297-6150

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 720-848-0650

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 970-203-7083

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 860-972-4700

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 860-545-5363

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 866-662-5678

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 860-224-5660

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 203-323-8944

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 561-955-4800

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 786-596-2000

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 404-489-9164

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 888-946-7447

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 404-778-1868

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 404-851-7115

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 847-842-4847

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 312-355-3046

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 773-296-5360

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 847-429-2907

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 708-799-9995

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 708-226-4357

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 630-646-6075

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 800-323-8622

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 847-384-3621

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 319-365-4673

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 319-363-2690

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 515-241-6727

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 515-241-3305

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 515-282-2200

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 785-295-8000

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 207-885-7565

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 207-459-1600

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 800-888-8823

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 443-643-3010

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 877-726-5130

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 877-442-3324

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 877-332-4294

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 781-624-5000

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 800-865-1125

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 800-865-1125

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 248-551-7695

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 517-364-9400

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 248-551-7695

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 248-551-7695

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 855-776-0015

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 601-815-6700

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 573-882-7440

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 314-996-5569

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 417-269-4520

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 402-559-5600

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 603-224-2556

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 800-439-3837

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 800-339-6484

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 856-325-6757

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 609-748-7200

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 609-631-6946

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 732-235-7356

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 732-235-7356

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 201-634-5792

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 856-325-6757

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 516-734-8896

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 718-520-6620

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 518-926-6700

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 516-734-8896

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 516-734-8896

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 212-434-4460

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 212-746-1848

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 718-312-3446

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 585-275-5830

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 914-366-1600

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 800-862-2215

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 315-464-5476

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 800-804-9376

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 980-442-2000

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 800-804-9376

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 800-804-9376

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 800-804-9376

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 888-275-3853

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 980-442-2000

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 919-862-5400

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 910-754-4716

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 910-251-1839

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 910-342-3000

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 336-713-6771

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 701-780-6520

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 503-413-2150

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 503-413-1742

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 610-776-4714

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 484-503-4151

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 717-721-4840

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 814-452-5000

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 877-441-7957

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 610-284-8237

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 724-838-1900

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 814-534-4724

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 412-858-7746

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 215-728-2983

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 877-284-2000

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 412-647-2811

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 412-784-4900

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 412-578-5000

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 412-647-8073

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 412-621-2334

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 412-367-6454

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 412-502-3920

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 610-776-4714

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 610-776-4714

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 814-676-7900

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 724-437-2503

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 610-431-5297

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 610-988-9323

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 877-441-7957

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 717-724-6760

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 401-444-1488

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 713-790-2700

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 281-242-2873

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 802-225-5400

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 503-413-2150

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 304-243-6442

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 855-776-0015

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 262-257-5100

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 414-805-3666

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 888-469-6614

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 414-805-0505

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 877-405-6866

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 414-805-0505

Principal Investigator

  • Paul L Nguyen

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 715-422-7718

Principal Investigator

  • Paul L Nguyen

Eligibility Criteria

Inclusion Criteria:

* PRIOR TO STEP 1 REGISTRATION
* Pathologically proven diagnosis of adenocarcinoma of prostate cancer within 180 days prior to registration
* High-risk disease defined as having at least one or more of the following:

* PSA > 20 ng/mL prior to starting ADT Note: Patients receiving a 5-alpha reductase inhibitor (ex. finasteride) at the time of enrollment are eligible. The baseline PSA value should be doubled for PSAs taken while on 5-alpha reductase inhibitors and the medication should be discontinued prior to randomization but a washout period is not required.
* cT3a-T4 by digital exam or imaging (American Joint Committee on Cancer [AJCC] 8th edition [Ed.])
* Gleason score of 8-10
* Node positive by conventional imaging with a short axis of at least 1.0 cm
* Appropriate stage for study entry based on the following diagnostic workup:

* History/physical examination within 120 days prior to registration;
* Bone imaging within 120 days prior to registration;

* Note: To be eligible, patient must have no definitive evidence of bone metastases (M0) on bone scan or sodium fluoride (NaF) PET within 120 days prior to registration (negative NaF PET/CT or negative Axumin or choline PET or negative fluciclovine, choline or prostate-specific membrane antigen (PSMA) PET within 120 days prior to registration is an acceptable substitute if they have been performed). Patients who have bone metastases established only fluciclovine, choline, or PSMA PET but not definitive on bone scan or NaF PET will still be eligible
* CT or MRI of the pelvis within 120 days prior to registration (negative fluciclovine, choline, or PSMA PET within 120 days prior to registration is an acceptable substitute). As with bone staging, nodal staging for trial purposes will be based off of conventional imaging findings only
* Patients with confirmed N1 metastases on conventional imaging (CT/MRI) as defined by ≥10 mm on short axis are eligible but will be automatically assigned to the intensification study. Patients who are positive by fluciclovine, choline, or PSMA PET (i.e. N1), but whose nodes do not meet traditional size criteria for positivity (i.e. they measure ≥ 10 mm on either the CT or MRI portion of the PET or on a dedicated CT or MRI) will not be considered N1 for the trial and will not automatically be assigned to the intensification study
* Age ≥ 18
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 120 days prior to registration
* Hemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors (within 120 days prior to registration)
* Platelet count ≥ -100 x 10^3/uL independent of transfusion and/or growth factors (within 120 days prior to registration)
* Creatinine clearance (CrCl) ≥ 30 mL/min estimated by Cockcroft-Gault equation (within 120 days prior to registration)

* For Black patients whose renal function is not considered adequate by Cockcroft-Gault formula, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) may be used for calculating creatinine clearance for trial eligibility
* Either a CrCl ≥ 30 ml/min or calculated glomerular filtration rate (GFR) ≥ 30 will make a patient eligible
* Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 120 days prior to registration)

* Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject is eligible
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x institutional ULN (within 120 days prior to registration)
* Serum albumin ≥ 3.0 g/dL (within 120 days prior to registration)
* The patient must agree to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agree to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial and have a CD4 count ≥ 200 cells/microliter within 60 days prior to registration. Note: HIV testing is not required for eligibility for this protocol. Of note, for patients with HIV in the intensification trial randomized to apalutamide, highly active antiretroviral therapy (HAART) may need to be adjusted to medications that do not interact with apalutamide
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable after or on suppressive therapy within 60 days prior to registration, if indicated. Note: HBV viral testing is not required for eligibility for this protocol
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ or low-grade non-muscle invasive bladder cancer) who has been disease-free for less than 3 years must contact the principal investigator
* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
* PRIOR TO STEP 2 RANDOMIZATION
* Confirmation of Decipher score
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load within 60 days prior. Note: Apalutamide may interfere with HCV drugs. Patients on HCV medications should alert their infectious diseases physician if they get randomized to apalutamide due to the possibility that apalutamide can affect the bioavailability of some HCV medications. HCV viral testing is not required for eligibility for this protocol
* For patients entering the Intensification Cohort ONLY: Patients must discontinue or substitute concomitant medications known to lower the seizure threshold at least 30 days prior to Step 2 randomization

Exclusion Criteria:

* PRIOR TO STEP 1 REGISTRATION:
* Definitive radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI)
* Prior systemic chemotherapy within ≤ 3 years prior to registration; note that prior chemotherapy for a different cancer is allowed (completed > 3 years prior to registration
* Prior radical prostatectomy
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
* Current use of 5-alpha reductase inhibitor. NOTE: If the alpha reductase inhibitor is stopped prior to randomization the patient is eligible
* History of any of the following:

* Seizure disorder
* Current severe or unstable angina
* New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)
* History of any condition that in the opinion of the investigator, would preclude participation in this study
* Evidence of any of the following at registration:

* Active uncontrolled infection requiring IV antibiotics
* Baseline severe hepatic impairment (Child Pugh Class C)
* Inability to swallow oral pills
* Any current condition that in the opinion of the investigator, would preclude participation in this study
* Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone-releasing hormone [LHRH] agonist and oral anti-androgen) is ≤ 60 days prior to registration; Please note: baseline PSA must be obtained prior to the start of any ADT
* PRIOR TO STEP 2 RANDOMIZATION:
* Evidence of known gastrointestinal disorder affecting absorption of oral medications at registration
* For patients entering the Intensification Cohort ONLY: Presence of uncontrolled hypertension (persistent systolic blood pressure [BP] ≥ 160 mmHg or diastolic BP ≥ 100 mmHg). Subjects with a history of hypertension are allowed, provided that BP is controlled to within these limits by anti-hypertensive treatment

Study Plan

Arm I (de-intensification study)

ACTIVE_COMPARATOR

Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin and bicalutamide or flutamide) for 24 months in the absence of disease progression or unacceptable toxicity.

  • DRUG:

    Bicalutamide

    Description:

    Antiandrogen

  • DRUG:

    Buserelin

    Description:

    Luteinizing hormone-releasing hormone (LHRH) agonist

  • DRUG:

    Degarelix

    Description:

    Gonadotropin-releasing hormone (GnRH) antagonist

  • DRUG:

    Flutamide

    Description:

    Antiandrogen

  • DRUG:

    Goserelin

    Description:

    Gonadotropin-releasing hormone (GnRH) agonist

  • DRUG:

    Histrelin

    Description:

    Gonadotropin-releasing hormone (GnRH) agonist

  • DRUG:

    Leuprolide

    Description:

    Gonadotropin-releasing hormone (GnRH) agonist

  • OTHER:

    Quality-of-Life Assessment

    Description:

    Ancillary studies

  • OTHER:

    Questionnaire Administration

    Description:

    Ancillary studies

  • RADIATION:

    Radiation Therapy

    Description:

    Undergo radiation therapy

  • DRUG:

    Triptorelin

    Description:

    Gonadotropin-releasing hormone (GnRH) agonist

Arm II (de-intensification study)

EXPERIMENTAL

Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin and bicalutamide or flutamide) for 12 months in the absence of disease progression or unacceptable toxicity.

  • DRUG:

    Bicalutamide

    Description:

    Antiandrogen

  • DRUG:

    Buserelin

    Description:

    Luteinizing hormone-releasing hormone (LHRH) agonist

  • DRUG:

    Degarelix

    Description:

    Gonadotropin-releasing hormone (GnRH) antagonist

  • DRUG:

    Flutamide

    Description:

    Antiandrogen

  • DRUG:

    Goserelin

    Description:

    Gonadotropin-releasing hormone (GnRH) agonist

  • DRUG:

    Histrelin

    Description:

    Gonadotropin-releasing hormone (GnRH) agonist

  • DRUG:

    Leuprolide

    Description:

    Gonadotropin-releasing hormone (GnRH) agonist

  • OTHER:

    Quality-of-Life Assessment

    Description:

    Ancillary studies

  • OTHER:

    Questionnaire Administration

    Description:

    Ancillary studies

  • RADIATION:

    Radiation Therapy

    Description:

    Undergo radiation therapy

  • DRUG:

    Triptorelin

    Description:

    Gonadotropin-releasing hormone (GnRH) agonist

Arm III (intensification study)

ACTIVE_COMPARATOR

Patients undergo RT over 2-11 weeks and receive ADT as in Arm I.

  • DRUG:

    Bicalutamide

    Description:

    Antiandrogen

  • DRUG:

    Buserelin

    Description:

    Luteinizing hormone-releasing hormone (LHRH) agonist

  • DRUG:

    Degarelix

    Description:

    Gonadotropin-releasing hormone (GnRH) antagonist

  • DRUG:

    Flutamide

    Description:

    Antiandrogen

  • DRUG:

    Goserelin

    Description:

    Gonadotropin-releasing hormone (GnRH) agonist

  • DRUG:

    Histrelin

    Description:

    Gonadotropin-releasing hormone (GnRH) agonist

  • DRUG:

    Leuprolide

    Description:

    Gonadotropin-releasing hormone (GnRH) agonist

  • OTHER:

    Quality-of-Life Assessment

    Description:

    Ancillary studies

  • OTHER:

    Questionnaire Administration

    Description:

    Ancillary studies

  • RADIATION:

    Radiation Therapy

    Description:

    Undergo radiation therapy

  • DRUG:

    Triptorelin

    Description:

    Gonadotropin-releasing hormone (GnRH) agonist

Arm IV (intensification study)

EXPERIMENTAL

Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin) for 24 months in the absence of disease progression or unacceptable toxicity. Patients also receive apalutamide PO QD. Treatment repeats every 90 days for up to 8 cycles (24 months) in the absence of disease progression or unacceptable toxicity.

  • DRUG:

    Apalutamide

    Description:

    Nonsteroidal Antiandrogen

  • DRUG:

    Buserelin

    Description:

    Luteinizing hormone-releasing hormone (LHRH) agonist

  • DRUG:

    Degarelix

    Description:

    Gonadotropin-releasing hormone (GnRH) antagonist

  • DRUG:

    Goserelin

    Description:

    Gonadotropin-releasing hormone (GnRH) agonist

  • DRUG:

    Histrelin

    Description:

    Gonadotropin-releasing hormone (GnRH) agonist

  • DRUG:

    Leuprolide

    Description:

    Gonadotropin-releasing hormone (GnRH) agonist

  • OTHER:

    Quality-of-Life Assessment

    Description:

    Ancillary studies

  • OTHER:

    Questionnaire Administration

    Description:

    Ancillary studies

  • RADIATION:

    Radiation Therapy

    Description:

    Undergo radiation therapy

  • DRUG:

    Triptorelin

    Description:

    Gonadotropin-releasing hormone (GnRH) agonist

Outcome Measures

Primary Outcome Measures

Metastasis-free survival (MFS)

Time Frame: From randomization to the date of detection of distant metastasis on standard imaging or date of death from any cause, assessed up to 13 years

Secondary Outcome Measures

MFS

Time Frame: From randomization to the date of detection of distant metastasis on standard imaging or date of death from any cause, assessed up to 13 years

Overall survival

Time Frame: From the date of randomization to the date of death or last known follow-up date, with patients alive at the last known follow-up time treated as censored, assessed up to 13 years

Prostate cancer specific mortality (PCSM)

Time Frame: From the date of randomization to the date of prostate cancer death, assessed up to 13 years

Prostate specific antigen (PSA) failure-free survival with non-castrate testosterone and no additional therapies

Time Frame: From the date of randomization to the date event, or death or censored at the last known follow-up date, assessed up to 13 years

Time to testosterone recovery

Time Frame: Up to 13 years

Time to PSA failure or salvage therapy

Time Frame: Up to 13 years

Testosterone levels at the time of PSA failure and metastases

Time Frame: Up to 13 years

Incidence of adverse events

Time Frame: Up to 13 years

Timeline

  • Last Updated
    February 7, 2024
  • Start Date
    August 14, 2020
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    December 31, 2033

Similar Trials

A Randomised Controlled Trial to Evaluate the Impact of Complement Theory’s Live 1:1 Exercise ...
light-list-check RECRUITING light-blue-people 21 - 64 Years
A Dose Finding Study of Debio 4228 in Participants With Locally Advanced/Metastatic Prostate Cancer
light-list-check RECRUITING light-blue-people ≥ 18 Years
A Study of Mental Health Care in People with Cancer
light-list-check RECRUITING light-blue-people ≥ 65 Years