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Search / Trial NCT05169112

Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · Dec 22, 2021

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of hormonal therapy, specifically androgen deprivation therapy (ADT), on preventing prostate cancer from coming back after surgery. Prostate cancer is common in men, and many patients undergo surgery called radical prostatectomy to remove the cancer. However, about 40% of these patients may experience a recurrence of cancer afterward. This trial is testing whether giving ADT for one year right after surgery can help reduce the chances of the cancer returning for men who are at high risk of recurrence.

To participate in this trial, men aged 65 to 74 who have had surgery and have a very low level of a specific blood marker (PSA) are eligible, as long as they are predicted to have a 25% or greater chance of recurrence within five years. Participants will receive the ADT for one year and will be closely monitored for their health and cancer outcomes. It’s important to note that men who have already received ADT, have cancer spread to lymph nodes, or have allergies to ADT are not eligible. This trial aims to provide valuable information that could help improve treatment for prostate cancer patients in the future.

Gender

MALE

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

About Ottawa Hospital Research Institute

The Ottawa Hospital Research Institute (OHRI) is a leading academic research institute dedicated to advancing health and healthcare through innovative research and evidence-based practices. Affiliated with The Ottawa Hospital and the University of Ottawa, OHRI fosters a collaborative environment that brings together clinicians, scientists, and trainees to conduct groundbreaking clinical trials and translational research. With a focus on improving patient outcomes, OHRI specializes in a wide range of fields, including cancer, cardiovascular health, and regenerative medicine. The institute is committed to ethical research practices and the dissemination of knowledge to enhance public health and inform healthcare policy.

Locations

Ottawa, Ontario, Canada

Halifax, Nova Scotia, Canada

Montreal, Quebec, Canada

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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