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

Who is this study for? Patients with Prostate Cancer
What treatments are being studied? Lupron Depot
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Canada
Nova Scotia Health
RECRUITING
Halifax
Centre universitaire de santé McGill - McGill University Health Centre
NOT_YET_RECRUITING
Montreal
The Ottawa Hospital
RECRUITING
Ottawa
Contact Information
Primary
Rodney Breau, Dr.
rbreau@toh.on.ca
613-737-8899
Time Frame
Start Date: 2023-03-06
Estimated Completion Date: 2028-11
Participants
Target number of participants: 72
Treatments
No_intervention: Standard of Care
Standard of Care
Experimental: 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)
Sponsors
Collaborators: Tolmar Pharmaceuticals
Leads: Ottawa Hospital Research Institute

This content was sourced from clinicaltrials.gov

Similar Clinical Trials