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Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy

StatusRecruiting
PhasePhase 3
Started2023-03-06
View on ClinicalTrials.gov ↗

Amendment history

2025-03-17
minor
Study Status, Sponsor/Collaborators, Study Design, Eligibility, Contacts/Locations v3
Primary completion date2023-11→2026-11
Enrollment target40→72
Study sites1→3
Eligibility criteria+1 characters
Inclusion Criteria: undetectable PSA (<0.02 ng/ml) within 816 weeks post-operative; ≥25% predicted risk of PSA recurrence [...]
Collaborators+22 characters
Tolmar Pharmaceuticals
2023-03-21
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-11→confirmed 2023-03-06
2022-10-03
minor
Study Status v1
Primary completion date2023-03→2023-11
Completion date2028-03→2028-11
Start date2022-03→2022-11
2021-12-22
minor
Original filing
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.
Trial Details
NCT Number NCT05169112
Lead Sponsor Ottawa Hospital Research Institute
Collaborators: Tolmar Pharmaceuticals
Conditions Prostate Cancer
Enrollment 72 participants
Start Date 2023-03-06
Primary Completion 2026-11 (estimated)
Study Completion 2028-11 (estimated)
Updated on ClinicalTrials.gov 2025-03-20