Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer

Clinicaltrials.gov ID: NCT06734130
db-list-check Status RECRUITING
b-loader Phase PHASE2
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 25

Conditions

Metastatic Castration Sensitive Prostate Cancer

Drugs

Luteinizing Hormone-Releasing Hormone (LHRH) analog, Androgen Receptor Signal Inhibitor (ARSI), Docetaxel

Summary

This is a prospective single center phase IIa open label nonrandomized study, which aims to test the hypothesis that the duration of castration sensitive phase of stage IV prostate cancer can be prolonged with adaptive androgen deprivation therapy (ADT) and Docetaxel.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

  • Jingsong Zhang, MD, PhD

Principal Investigator

  • Jingsong Zhang, MD, PhD

Eligibility Criteria

Inclusion Criteria:

* Biopsy proven prostate cancer and the diagnosis can be established through either prostate biopsy or biopsy of a metastatic lesion.
* No androgen deprivation therapy (ADT) with LHRH analog for more than 4 weeks after the diagnosis of metastatic prostate cancer. Prior ADT in the non-metastatic setting is allowed if it was given > 2 years prior to the diagnosis of metastatic prostate cancer.
* Achieved >50% PSA decline and <4 ng/ml PSA after the run-in period.
* Adequate organ function with absolute neutrophil count > 1000/l, Hb > 10 g/dl, Platelet > 100,000/l, Creatinine and liver enzymes within 1.5 folds of upper limits of normal.
* No uncontrolled arrhythmia; patients with h/o myocardia infarction or history of congestive heart failure, need to have estimated left ventricle ejection fraction above 40% either on echocardiogram or MUGA scan within 6 months of study enrollment.
* ECOG performance status 0-1.
* Non-sterilized men who are sexually active with a female partner of childbearing potential treated or enrolled on this protocol must agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 weeks after last dose of ARSI or docetaxel administration.
* Ability to understand and the willingness to sign a written informed consent document or have a legally authorized representative sign on the subject's behalf. Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria:

* Prior treatments with TAK-700/Orteronel, abiraterone, apalutamide or enzalutamide.
* Surgical castration.
* Documented liver or brain metastases
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel (including any drugs formulated with polysorbate 80), or LHRH analog (e.g., leuprolide, triptorelin, relugolix, degarelix)
* Treatment with any investigational compound within 30 days prior to the first dose of study drugs.
* Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of LHRH analog, or previously diagnosed with another malignancy & have any evidence of residual disease. Patients with early-stage skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Subjects with delayed healing of wounds, ulcers, and/or bone fractures.

Study Plan

Adaptive Androgen Deprivation and Docetaxel Treatment

EXPERIMENTAL

This study will consist of various visits: a screening visit, 1-3 visits during the screening standard of care treatment period and visits every 4 weeks during the adaptive therapy period.

  • DRUG:

    Luteinizing Hormone-Releasing Hormone (LHRH) analog

    Description:

    The choice of the standard of care LHRH analog will be at the discretion of the treating physician.
  • DRUG:

    Androgen Receptor Signal Inhibitor (ARSI)

    Description:

    The choice of the standard of care ARSI will be at the discretion of the treating physician.
  • DRUG:

    Docetaxel

    Description:

    Docetaxel will be given by IV infusion at 75mg/m2 once every 3 weeks.

Outcome Measures

Primary Outcome Measures

Castration Sensitivity Rate

Time Frame: Up to 36 months

Secondary Outcome Measures

On treatment PSA Progression Free Survival

Time Frame: Up to 36 months

Radiographic Progression Free Survival

Time Frame: Up to 36 months

Overall Survival

Time Frame: Up to 36 months

Patient Reported Outcome

Time Frame: Up to 36 months

Timeline

  • Last Updated
    December 30, 2024
  • Start Date
    December 16, 2024
  • Today
    May 11, 2025
  • Completion Date ( Estimated )
    December 1, 2027

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