Postop Hypofractionated Radiation Therapy and LHRH in Patients With Prostate Cancer

• Status: Recruiting
• Trial end date: 2025-12-15
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Luis Souhami; McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborator: Sanofi
• Treatments: Leuprolide

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-prostatectomy must be below 2.0 ng/ml (salvage group). Any type of prostatectomy will be permitted

• Negative bone metastases proven by bone scan. The use of proton emission tomography (PET) fluoride is allowed

• History and physical examination (including digital rectal exam) within 90 days prior of registration

• Adequate marrow reserve defined as: Hemoglobin ≥ 10 g/dl (patients may be transfused in order to achieve this level); Platelets ≥ 100 000 cells/mm3 and a white blood cell count of ≥ 4000 cells/ml3

• AST or ALT <2 x the upper limit of normal

• PSA and testosterone levels within one month of registration Age ≥ 18

• Zubrod Performance Status 0-1

• Patients must sign a study-specific consent form

Exclusion Criteria:

• Previous exposure to androgen deprivation

• Chemotherapy before or after prostatectomy

• Prior pelvic radiotherapy

• Previous malignancies (except non-melanomatous skin cancer) unless disease-free >5 years

• Severe, active medical condition that makes the use of any of the therapies of the study not recommended