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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Patients randomized to receive androgen deprivation therapy (ADT) will receive 12 months of Lupron Depot (22.5 mg) administered every 3 months
Nova Scotia Health
Halifax, Nova Scotia, Canada
RECRUITINGThe Ottawa Hospital
Ottawa, Ontario, Canada
RECRUITINGCentre universitaire de santé McGill - McGill University Health Centre
Montreal, Quebec, Canada
NOT_YET_RECRUITINGRate of enrolment
Rate (patients/month) of enrolment
Time frame: 1 year
Rate of enrolment per site
Rate (patients/month) of enrolment per site
Time frame: 1 year
Proportion of patients completing study intervention per-protocol
Proportion of patients completing study intervention per-protocol
Time frame: 1 year
Time to study start-up
Time to study start-up at each site
Time frame: 1 year
Completeness of study assessments
Proportion of study assessments completed per-protocol
Time frame: 1 year
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