Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy
Recruiting
Phase 3
Interventional Study
Prostate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 72 (estimated)
- Sponsor
- Ottawa Hospital Research Institute · Other
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About This Trial
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…
Trial Locations
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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…
Contacts