NCT05169112

Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Lupron Depot	Patients randomized to receive androgen deprivation therapy (ADT) will receive 12 months of Lupron Depot (22.5 mg) administered every 3 months

Timeline

• Start date: 2023-03-06
• Primary completion: 2026-11-01
• Completion: 2028-11-01
• First posted: 2021-12-23
• Last updated: 2025-03-20

Locations

3 sites across 1 country: Canada