Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy

Study 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.

Official Title
-----------------
The Impact of Adjuvant Androgen Deprivation Following Radical Prostatectomy on Prostate Cancer Recurrence

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Lupron Depot


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undetectable PSA (<0.02 ng/ml) within 8 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Standard of Care | |
| Experimental: Standard of Care plus Androgen Deprivation Therapy (Lupron Depot)<br>22.5 mg intra-muscular injection of Lupron Depot every 3 months for 12 months (4 injections total) | Drug: Lupron Depot<br>* Patients randomized to receive androgen deprivation therapy (ADT) will receive 12 months of Lupron Depot (22.5 mg) administered every 3 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of enrolment | Rate (patients/month) of enrolment | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of enrolment per site | Rate (patients/month) of enrolment per site | 1 year | 
| Proportion of patients completing study intervention per-protocol | Proportion of patients completing study intervention per-protocol | 1 year | 
| Time to study start-up | Time to study start-up at each site | 1 year | 
| Completeness of study assessments | Proportion of study assessments completed per-protocol | 1 year |