Last updated: January 12, 2023
Sponsor: Jonsson Comprehensive Cancer Center
Overall Status: Terminated
Phase
3
Condition
Prostate Cancer
Prostate Disorders
Prostate Cancer, Early, Recurrent
Treatment
N/AClinical Study ID
NCT04457245
20-000378
NCI-2020-03445
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 theradiotherapy 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 theduration of the study
Exclusion
Exclusion Criteria:
- Less than 18 years old at the time of investigational product administration
- Extra-pelvic metastasis (M1 disease) on any imaging or biopsy done beforerandomization
- 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
Study Design
Total Participants: 54
Study Start date:
August 14, 2020
Estimated Completion Date:
January 10, 2023
Study Description
Connect with a study center
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California 90095
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.