Recruiting
Phase 3

Hormonal Therapy

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT05169112

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lupron Depot

Study Details

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 ID

NCT05169112

Start date

Mar 6, 2023

Status verified date

Mar, 2025

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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)

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

Primary outcome measure

  • Rate of enrolment [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Rodney Breau, Dr.

613-737-8899rbreau@toh.on.ca

Locations

Nova Scotia Health

Recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Contacts

Ricardo Rendon, MD

902-425-3940Ricardo.Rendon@nshealth.ca

Principal Investigator:

Ricardo Rendon, Dr.

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Rodney H Breau, MD, FRCSC

613-737-8899rbreau@ottawahospital.on.ca

Pascale Juneau, MASc

613-737-8899pjuneau@ohri.ca

Principal Investigator:

Rodney H Breau, MD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Mar 20, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2025-03-20.