Clinical trial · Interventional
Adjuvant Radiation Therapy vs. Watchful Waiting Following Radical Prostatectomy in High Risk Prostate Cancer
Adjuvant Radiation Therapy vs. Watchful Waiting in Prostate Cancer Patients With Positive Margins or Capsular Penetration After Radical Prostatectomy
NCT02668718CI-TRIAL-00020740unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine whether adjuvant radiotherapy following radical prostatectomy in prostate cancer patients with positive margins or capsular penetration improves biochemical, overall and/or cancer specific survival and whether adjuvant radiotherapy is reasonably well tolerated when compared to watchful waiting.
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 |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Adjuvant radiotherapy
- description
- Patients who were randomized to adjuvant radiotherapy following radical prostatectomy
- interventionNames
- Radiation: Adjuvant radiotherapy
- type
- NO_INTERVENTION
- label
- Watchful waiting
- description
- Patients who were randomized to watchful waiting following radical prostatectomy
Primary outcomes (3)
- measure
- Biochemical disease-free survival
- timeFrame
- Five years
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: Patients with pT3aN0M0 or pT2N0M0 prostate cancer with a positive margin, gleason score 2-10, preoperative PSA \< 20 ug/l, postoperative PSA \<0.5 ug/l after surgery (within 8 weeks), the WHO performance status 0-2, life expectancy at least 3 months, informed consent obtained. Exclusion Criteria: Other simultaneous cancer therapy including systemic endocrine therapy; more than 12 weeks has elapsed since surgery for prostate cancer; metastatic disease (N+ or M1); cancer invasion to the seminal vesicles; any other previous malignancy within the last 5 years except basalioma or squamous cell carcinoma of the skin; any contraindication to irradiation (severe locoregional infection, prior radiation therapy to the prostate/bladder); any physical or mental condition, which in the opinion of the investigator, may interfere with patient's ability to comply with scheduled visits.
References
Publications (0)
Data not yet available
No reference posted for this study.