Clinical trial · Interventional
Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer
Radical Prostatectomy for Locally Advanced Prostate Cancer. A Feasibility Study
NCT00027794CI-TRIAL-00008113completedPhase 2ClinicalTrials.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)
RATIONALE: Radical prostatectomy may be an effective treatment for locally advanced prostate cancer. PURPOSE: Phase II trial to study the effectiveness of radical prostatectomy in treating patients who have locally advanced prostate cancer.
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 |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Unilateral cT3a, cN0, M0 * Well or moderately differentiated tumor * Gleason score no greater than 7 (4 plus 3 or 3 plus 4) * Total serum prostate-specific antigen no greater than 20 ng/mL (Hybritech equivalent) PATIENT CHARACTERISTICS: Age: * 70 and under Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * WBC greater than 3,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 9 g/dL Hepatic: * Bilirubin no greater than 1.5 times normal * ALT or AST less than 3 times normal * PT and PTT normal Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No preexisting uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy * No myocardial infarction within the past 6 months Pulmonary: * No gross abnormalities on chest x-ray Other: * No other disease that would preclude surgery * No other prior malignancy except adequately treated basal cell skin cancer * No other concurrent primary malignancy * No psychological, familial, sociological, or geographical condition that would preclude compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * No prior hormonal therapy that would affect assessment of clinical T staging, margin positivity, or definitive pT staging Radiotherapy: * No prior pelvic radiotherapy that would affect surgical resectability and perioperative morbidity Surgery: * No prior surgery in the small pelvis (vascular surgery, mesh graft hernia repair, any surgery for benign prostatic hypertrophy, or transurethral resection of prostate) that would preclude prostatectomy
References
Publications (1)
- RESULTVan Poppel H, Vekemans K, Da Pozzo L, Bono A, Kliment J, Montironi R, Debois M, Collette L. Radical prostatectomy for locally advanced prostate cancer: results of a feasibility study (EORTC 30001). Eur J Cancer. 2006 May;42(8):1062-7. doi: 10.1016/j.ejca.2005.11.030. Epub 2006 Apr 18. PMID 16624554