Prostate Cancer
Conditions
Brief summary
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.
Interventions
DRUGLupron Depot
Patients randomized to receive androgen deprivation therapy (ADT) will receive 12 months of Lupron Depot (22.5 mg) administered every 3 months
Sponsors
Tolmar Pharmaceuticals
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. undetectable PSA (\<0.02 ng/ml) within 16 weeks post-operative; 2. ≥25% predicted risk of PSA recurrence within 5 years of surgery (based on the Kattan nomogram)
Exclusion criteria
1. Unwilling to receive ADT; 2. previously received ADT; 3. lymph node metastases 4. allergy to any form of ADT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of enrolment | 1 year | Rate (patients/month) of enrolment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of enrolment per site | 1 year | Rate (patients/month) of enrolment per site |
| Proportion of patients completing study intervention per-protocol | 1 year | Proportion of patients completing study intervention per-protocol |
| Time to study start-up | 1 year | Time to study start-up at each site |
| Completeness of study assessments | 1 year | Proportion of study assessments completed per-protocol |
Countries
Canada
Contacts
Primary ContactRodney Breau, Dr.
Outcome results
None listed