NCT04249154 Postop Hypofractionated Radiation Therapy and LHRH in Patients With Prostate Cancer
| NCT ID | NCT04249154 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 77 participants |
| Start Date | 2019-09-03 |
| Primary Completion | 2026-12-15 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
Inclusion Criteria: * Histologically proven high risk (any of the following risk factors: surgical positive margins; extra-capsular extension; seminal vesicle involvement, Gleason score \>7) adenocarcinoma of the prostate after a radical prostatectomy as primary treatment (adjuvant group), with pathologically negative lymph nodes dissection or clinically negative lymph nodes by imaging \[pelvic and abdominal computed tomography (CT) scan, or magnetic resonance imaging (MRI)\]. Lymphadenectomy is not mandatory. Any type of prostatectomy will be permitted. For this group of patients, the PSA level at time of entry must be below 0.4 ng/ml * Histologically proven adenocarcinoma after a radical prostatectomy with pathologically negative lymph nodes (lymphadenectomy is not mandatory) or clinically negative lymph nodes by imaging (pelvic and abdominal CT scan, or MRI or) and evidence of biochemical failure (defined as two consecutives rises of the PSA, at any PSA level). PSA upper limit post-
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