Actively Recruiting
Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy
Led by Ottawa Hospital Research Institute · Updated on 2025-03-20
72
Participants Needed
3
Research Sites
295 weeks
Total Duration
On this page
Sponsors
O
Ottawa Hospital Research Institute
Lead Sponsor
T
Tolmar Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Prostate cancer is the most common cancer in men and radical prostatectomy is the most frequent treatment for this disease. Unfortunately, approximately 40% of patients will develop recurrence after surgery, requiring additional salvage radiation. Salvage radiation after recurrence is successful in less than half of these men and most of those die from their disease. Measures to prevent recurrence are an important research priority for prostate cancer patients and their families. Hormonal therapy (androgen deprivation therapy; ADT) is routinely used to treat patients with metastases, but few clinical trials have examined if adjuvant ADT after surgery will prevent cancer recurrence. We aim to address this research oversight and test the hypothesis that for men at high risk of cancer recurrence, 1 year of ADT immediately after surgery will be safe and will significantly improve cancer outcomes.
CONDITIONS
Official Title
Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undetectable PSA (<0.02 ng/ml) within 16 weeks after surgery
- Predicted risk of PSA recurrence within 5 years of surgery is 25% or higher based on Kattan nomogram
You will not qualify if you...
- Unwilling to receive androgen deprivation therapy (ADT)
- Previously received ADT
- Presence of lymph node metastases
- Allergy to any form of ADT
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Nova Scotia Health
Halifax, Nova Scotia, Canada, B3H 2Y9
Actively Recruiting
2
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
3
Centre universitaire de santé McGill - McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Not Yet Recruiting
Research Team
R
Rodney Breau, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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