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NCT05169112RecruitingPhase 3

Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy

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

Source: ClinicalTrials.gov · Last updated 20 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
72 (estimated)
First submitted
1 Mar 2021
Start date
6 Mar 2023
Primary completion date
Nov 2026
Lead sponsor
Ottawa Hospital Research Institute
NCT number
NCT05169112

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 72
  • From 6 Mar 2023 to the primary completion date, Nov 2026
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • previously received ADT;

Other illness

  • allergy to any form of ADT

Other

  • Unwilling to receive ADT;
  • lymph node metastases

Who the study is looking for

  • undetectable PSA (\<0.02 ng/ml) within 16 weeks post-operative;
  • ≥25% predicted risk of PSA recurrence within 5 years of surgery (based on the Kattan nomogram)

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Nova Scotia Health
Coordinator of this site? Confirm its status
HalifaxCanadaRecruiting
Centre universitaire de santé McGill - McGill University Health Centre
Coordinator of this site? Confirm its status
MontrealCanadaNot yet recruiting
The Ottawa Hospital
Coordinator of this site? Confirm its status
OttawaCanadaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.