The Impact of Adjuvant Androgen Deprivation Following Radical Prostatectomy on Prostate Cancer Recurrence
Overview
- Phase
- Phase 3
- Intervention
- Lupron Depot
- Conditions
- Prostate Cancer
- Sponsor
- Ottawa Hospital Research Institute
- Enrollment
- 72
- Locations
- 3
- Primary Endpoint
- Rate of enrolment
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Rodney Breau
Dr.
Ottawa Hospital Research Institute
Eligibility Criteria
Inclusion Criteria
- •undetectable PSA (\<0.02 ng/ml) within 16 weeks post-operative;
- •≥25% predicted risk of PSA recurrence within 5 years of surgery (based on the Kattan nomogram)
Exclusion Criteria
- •Unwilling to receive ADT;
- •previously received ADT;
- •lymph node metastases
- •allergy to any form of ADT
Arms & Interventions
Standard of Care plus Androgen Deprivation Therapy (Lupron Depot)
22.5 mg intra-muscular injection of Lupron Depot every 3 months for 12 months (4 injections total)
Intervention: Lupron Depot
Outcomes
Primary Outcomes
Rate of enrolment
Time Frame: 1 year
Rate (patients/month) of enrolment
Secondary Outcomes
- Completeness of study assessments(1 year)
- Time to study start-up(1 year)
- Rate of enrolment per site(1 year)
- Proportion of patients completing study intervention per-protocol(1 year)