Clinical trial · Interventional
Radical Retropubic Prostatectomy Versus Conventional External Beam Radiotherapy for Clinically Localized Prostate Cancer
NCT02091661CI-TRIAL-00044230suspendedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): accrual too slow
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the effectiveness of the two most established primary treatments for patients with clinically localized prostate cancer: radical retropubic prostatectomy, and external-beam radiotherapy. The primary aim is assessing biochemical disease-free survival, overall survival, and prostate cancer-specific survival. As secondary objectives quality of Life impact of treatments' side effects will be also assessed.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| External beam radiotherapy | Radiation | — | UNRESOLVED |
| Radical retropubic prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Radical retropubic prostatectomy
- description
- The surgery arm underwent radical retropubic prostatectomy, performed by a technique described by Walsh.surgery started with dissection of the pelvic lymph nodes. If there were no signs of metastasis in frozen sections, the operation was continued with retropubic radical prostatectomy. The prostatectomy is performed in retrograde way, preserving the neurovascular bundles if feasible. The degree to which the surgeon preserve the nerves is categorized as non-nerve-sparing, unilateral nerve-sparing, or bilateral nerve-sparing.The operative time is about 2 to 3 hours and required hospital stay. The patient has a urinary catheter placed for 6 to 9 days to facilitate bladder emptying.
- interventionNames
- Procedure: Radical retropubic prostatectomy
- type
- ACTIVE_COMPARATOR
- label
- External beam radiotherapy
- description
- External beam radiotherapy is carried out with intensity-modulated radiation technique. The treatment is designed to maximize the radiation dose to the prostate and seminal vesicles and minimize exposure to surrounding structures, including the bladder and rectum. Radiation to the prostate was delivered in fractionated doses divided over multiple treatments (180 to 200 centigray (cGy) daily fractions, 5 days per week) for a total dose to the prostate of 68 to 77 gray (Gy), prescribed at 90% to 100% of the isodose line.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age 75 years or younger * Diagnosis of prostate cancer, as verified by cytologic or histologic examination the tumor is well differentiated to moderately well differentiated * Untreated, clinically localized prostate cancer, with a tumor stage of T1, or T2 * Prostate specific antigen (PSA) level of ≤10 ng/ml * Bone scan with no abnormalities * Health status that would permit radical prostatectomy * Life expectancy of more than 10 years. Exclusion Criteria: * PSA \>10 ng/ml * Bone scan consistent with metastatic disease * Other evidence that cancer of the prostate is not clinically localized * Life expectancy less than 10 years * Serum creatinine greater than 3 mg/dl * Myocardial infarction within last 6 months * Unstable angina Class III or IV * Severe pulmonary disease * Liver failure * Severe dementia * Debilitating illness Malignancies, except for nonmelanomatous skin cancer, in the last 5 years.
References
Publications (0)
Data not yet available
No reference posted for this study.