Status:
TERMINATED
Randomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
Progenics Pharmaceuticals, Inc.
Conditions:
Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8
Stage II Prostate Cancer AJCC v8
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
This randomized phase III trial studies the success rate of definitive radiation therapy (dRT) for prostate cancer (PCa) with or without planning based on PSMA PET. PSMA- PET-based dRT, may improve ra...
Detailed Description
PRIMARY OBJECTIVE: I. To compare the outcome of patients with unfavorable intermediate (IR) and high-risk (HR) prostate cancer (PCa) after standard dRT versus prostate-specific membrane antigen (PSMA...
Eligibility Criteria
Inclusion
- Adult male 18 years or older
- Histopathologically-proven PCa
- Unfavorable IR to HR disease:
- Prostate specific antigen (PSA) \>= 10 ng/mL
- Or cT-stage \>= 2b
- Or Gleason grade 3 (4+3=7) or higher
- Or Gleason grade 2 (3+4=7) AND \>= 50% positive biopsy cores
- Or Decipher Score \>= 0.45
- Treating radiation oncologist intends to incorporate PSMA PET findings into the radiotherapy plan, if patient undergoes PSMA PET (intervention arm 2)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion
- Less than 18 years old at the time of investigational product administration
- Extra-pelvic metastasis (M1 disease) on any imaging or biopsy done before randomization
- Prior PSMA PET
- Prior pelvic RT
- Contraindications to radiotherapy (including active inflammatory bowel disease)
- Concurrent or prior surgery or systemic therapy for PCa at the time of randomization
Key Trial Info
Start Date :
August 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2023
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04457245
Start Date
August 14 2020
End Date
January 10 2023
Last Update
January 17 2023
Active Locations (1)
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1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095