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Clinical trial Recruiting at 2 sites Phase 3 Interventional Ages 18 and up Men only

Hormonal therapy's effect on prostate cancer recurrence after surgery

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

Run by Ottawa Hospital Research Institute · NCT05169112 · Data updated 2026-11-12

This study tests if giving hormone therapy right after prostate surgery can help prevent cancer from coming back in men at high risk of recurrence.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment72 (estimated)
SponsorOttawa Hospital Research Institute
Academic / other
Drugs / interventionsradiation
Locations3 sites (Halifax, Nova Scotia and 2 other locations)
StatusRecruiting
StartedMarch 6, 2023
Main results expectedNovember 2026
Study endsNovember 2028
Registry record updatedMarch 20, 2025
Trial IDNCT05169112 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are men who have undergone radical prostatectomy and have a predicted risk of PSA recurrence of 25% or higher.

Probably not a fit

Patients who have previously received ADT or have lymph node metastases may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of one year of androgen deprivation therapy (ADT) on preventing recurrence of prostate cancer in men who have undergone radical prostatectomy. The study focuses on patients with undetectable PSA levels post-surgery and a significant predicted risk of recurrence. By administering ADT immediately after surgery, the trial aims to determine if this approach can improve cancer outcomes for high-risk patients. The intervention involves the use of Lupron Depot as the hormonal therapy.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the rate of prostate cancer recurrence in high-risk patients after surgery.

How similar studies have gone: While hormonal therapy is commonly used for metastatic prostate cancer, few studies have specifically tested its effectiveness as an adjuvant treatment after surgery, making this approach relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Nova Scotia Health
    Halifax, Nova Scotia, Canada     Recruiting
  • The Ottawa Hospital
    Ottawa, Ontario, Canada     Recruiting
  • Centre universitaire de santé McGill - McGill University Health Centre
    Montreal, Quebec, Canada     Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.