Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy

Phase 3

Recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: Lupron Depot

• Registration Number: NCT05169112
• Lead Sponsor: Ottawa Hospital Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-12-22
• Study First Posted: 2021-12-23
• Study Start: 2023-03-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2026-11
• Study Completion: 2028-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care plus Androgen Deprivation Therapy (Lupron Depot)	Lupron Depot	22.5 mg intra-muscular injection of Lupron Depot every 3 months for 12 months (4 injections total)

Primary Outcome Measures

Name	Time	Method
Rate of enrolment	1 year	Rate (patients/month) of enrolment

Secondary Outcome Measures

Name	Time	Method
Completeness of study assessments	1 year	Proportion of study assessments completed per-protocol
Time to study start-up	1 year	Time to study start-up at each site
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

Trial Locations

Locations (3)

Nova Scotia Health; 🇨🇦 Halifax, Nova Scotia, Canada

Centre universitaire de santé McGill - McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada