Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lupron Depot | Drug | Leuprolide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard of Care
- description
- Standard of Care
- type
- EXPERIMENTAL
- label
- Standard of Care plus Androgen Deprivation Therapy (Lupron Depot)
- description
- 22.5 mg intra-muscular injection of Lupron Depot every 3 months for 12 months (4 injections total)
- interventionNames
- Drug: Lupron Depot
Primary outcomes (1)
- measure
- Rate of enrolment
- timeFrame
- 1 year
- description
- Rate (patients/month) of enrolment
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available