Hormonal therapy's effect on prostate cancer recurrence after surgery
The Impact of Adjuvant Androgen Deprivation Following Radical Prostatectomy on Prostate Cancer Recurrence
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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Halifax, Nova Scotia and 2 other locations) |
| Trial ID | NCT05169112 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who have previously received ADT or have lymph node metastases may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Halifax, Nova Scotia and 2 other locations
- 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
- Study coordinator: Rodney Breau, Dr.
- Email: rbreau@toh.on.ca
- Phone: 613-737-8899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.