Actively Recruiting
Postop Hypofractionated Radiation Therapy and LHRH in Patients With Prostate Cancer
Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2025-06-25
77
Participants Needed
2
Research Sites
432 weeks
Total Duration
On this page
Sponsors
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
T
Tolmar Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Postop Hypofractionated Radiation Therapy and LHRH in Patients With Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven high-risk prostate adenocarcinoma after radical prostatectomy with any of these: positive surgical margins, extracapsular extension, seminal vesicle involvement, or Gleason score over 7
- Pathologically or clinically negative lymph nodes confirmed by imaging or dissection
- PSA level below 0.4 ng/ml for adjuvant group or below 2.0 ng/ml with biochemical failure for salvage group
- Negative bone metastases confirmed by bone scan or PET fluoride
- History and physical exam including digital rectal exam within 90 days before enrollment
- Adequate blood counts: hemoglobin at least 10 g/dl, platelets at least 100,000 cells/mm3, white blood cells at least 4000 cells/mm3
- Liver enzymes AST or ALT less than twice the upper limit of normal
- PSA and testosterone levels measured within one month before enrollment
- Age 18 years or older
- Zubrod Performance Status 0 or 1
- Signed study-specific consent form
You will not qualify if you...
- Previous exposure to androgen deprivation therapy
- Chemotherapy before or after prostatectomy
- Prior pelvic radiotherapy
- Previous cancers except non-melanoma skin cancer unless disease-free for over 5 years
- Severe, active medical conditions making study treatments unsuitable
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
McGill University Health Centre- Cedars Cancer Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
2
McGill University Health Centre-Cedars Cancer Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
Research Team
F
Fabio Cury, MD
CONTACT
M
Marianna Perna, CCRP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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