Clinical Trial

Postop Hypofractionated Radiation Therapy and LHRH in Patients With Prostate Cancer

Study acronym: PROMPT
Recruiting Phase 2
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Summary
Prostate cancer is the second most common cancer among Canadian men of which approximately 20-30% present with high-risk tumour characteristic. Although surgery can be curative in patients evidencing pathological high-risk disease (extracapsular extension, seminal vesicle involvement, positive surgical margins), a large proportion will develop biochemical failure within years from the surgical procedure. The failure rate is even more pronounced in those patients that present with high prostate specific antigen (PSA) levels, pT3 disease, positive margins and Gleason score ≥8 with an estimated 75% failure rate at 10 years. Post-operative radiotherapy (RT) has been shown in three randomized trials to significantly decrease the biochemical failure rate and in one of the trials a survival benefit was also seen with the addition of post-operative RT and is considered by many investigators standard therapy in patients with pathological high-risks factors even in absence of biochemical failure.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2020-01-29; most recent amendment 2025-06-19.
Trial Details
NCT Number NCT04249154
Lead Sponsor McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators: Tolmar Inc.
Conditions Prostate Cancer
Enrollment 77 participants
Start Date 2019-09-03
Primary Completion 2026-12-15 (estimated)
Study Completion 2027-12-15 (estimated)
Updated on ClinicalTrials.gov 2025-06-25