Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy

NCT ID: NCT05169112

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-06
• Study Completion Date: 2028-11-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care

Standard of Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

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)

Group Type: EXPERIMENTAL

Lupron Depot

Intervention Type: DRUG

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

Interventions

Lupron Depot

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Tolmar Pharmaceuticals

UNKNOWN

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Rodney Breau

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nova Scotia Health

Halifax, Nova Scotia, Canada

Site Status: RECRUITING

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status: RECRUITING

Centre universitaire de santé McGill - McGill University Health Centre

Montreal, Quebec, Canada

Site Status: NOT_YET_RECRUITING

Countries

Canada

Central Contacts

Rodney Breau, Dr.

Role: CONTACT

rbreau@toh.on.ca

613-737-8899 ext. 73019

Facility Contacts

Ricardo Rendon, MD

Role: primary

Ricardo.Rendon@nshealth.ca

902-425-3940

Rodney H Breau, MD, FRCSC

Role: primary

rbreau@ottawahospital.on.ca

613-737-8899 ext. 73019

Pascale Juneau, MASc

Role: backup

pjuneau@ohri.ca

613-737-8899 ext. 73852

Other Identifiers

Adjuvant ADT Pilot

Identifier Type: -

Identifier Source: org_study_id