PyL in Patients With High Risk and Biochemically Recurrent Prostate Cancer
Conditions
Prostate CancerDrugs
DCFPyL PET/CTSummary
The standard of care imaging of prostate cancer metastases recommended by the National Comprehensive Cancer Network (NCCN), CT of the chest/abdomen/pelvis and bone scan, may be suboptimal. PyL is a novel PET tracer designed to detect prostate specific membrane antigen (PSMA) expressed on prostate cancer cells. PyL PET/CT may provide improved evaluation of clinically significant metastases in patients with prostate cancer.
Detailed Description
This will be a phase II clinical trial to assess the clinical value of PyL for detection of disease in pateints with:
1. High risk prostate cancer and planned prostatectomy or radiation therapy (arm 1) and
2. Biochemically recurrent prostate cancer (arm 2) but without evidence of disease of standard of care imaging (CT of the chest/abdomen/pelvis and bone scan).
In both cohorts, PyL PET/CT will be obtained and evaluated by a nuclear radiologist trained in novel PET radiotracers, including PyL. Lesions suspicious for disease of PyL that were unsuspected on standard of care imaging will be selected for biopsy for pathologic confirmation if feasible . Pathology will be used as the reference standard for confirming malignancy.
Locations
1 location Found with status Recruiting
Eligibility Criteria
Inclusion Criteria:
1. Male ≥ 18 years of age.
2. Histologically confirmed adenocarcinoma of the prostate
3. Patients meet one of the follow criteria:
Cohort 1: High risk prostate cancer (PSA >10, Gleason 8-10, or clinical stage >T2c) and planned prostatectomy or radiation therapy or Cohort 2: Biochemical prostate cancer relapse (Prostate Specific Antigen (PSA) > 0.2 ng/ml in patients following prostatectomy or ≥ 2 ng/ml more than the PSA nadir in patient following radiotherapy, as defined by the ASTRO-Phoenix criteria [18] and no evidence of malignancy on standard of care imaging for metastases (CT of the chest/abdomen/pelvis and bone scan) within 3 months.
Exclusion Criteria:
1. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
2. Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
3. Change in therapy since standard of care imaging
Study Plan
High risk prostate cancer
EXPERIMENTAL
DCFPyL PET/CT will be compared to CT/bone scan for detection of unsuspected metastases in patients with high risk prostate cancer and planned prostatectomy or or radiation therapy
DRUG:
DCFPyL PET/CTDescription:
Prostate Membrane Specific Antigen-specific imaging
Biochemically recurrent prostate cancer
EXPERIMENTAL
DCFPyL PET/CT will be utilized for detection of unsuspected metastases in patients with biochemically recurrent prostate cancer, but with no evidence of disease on CT/bone scan.
DRUG:
DCFPyL PET/CTDescription:
Prostate Membrane Specific Antigen-specific imaging
Outcome Measures
Primary Outcome Measures
Detection of unsuspected metastases in high risk prostate cancer
Detection of unsuspected metastases in biochemically recurrent prostate cancer
Timeline
Last Updated
July 27, 2021Start Date
January 7, 2021Today
January 16, 2025Completion Date ( Estimated )
December 15, 2022
Sponsors of this trial
Lead Sponsor
Hoag Memorial Hospital Presbyterian