Clinical trial · Interventional
Study of Peri-Operative Docetaxel Plus Laparoscopic Radical Prostatectomy in Prostate Cancer Patients
A Prospective Phase II of Peri-Operative Docetaxel + Laparoscopic Radical Prostatectomy in Patients With Localized Gleason 7 pT2a-pT2b Adenocarcinoma and a Risk of Relapse After Radical Prostatectomy
NCT00127088CI-TRIAL-00000433suspendedPhase 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)
This is a prospective phase II study of peri-operative docetaxel plus laparoscopic radical prostatectomy in patients with localized Gleason 7 pT2a-pT2b adenocarcinoma of the prostate and a risk of relapse after radical prostatectomy.
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 |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| laparoscopic radical prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Complete prostate specific antigen (PSA) response rate
Secondary outcomes (4)
- measure
- Toxicity
- measure
- Pathological response rate
- measure
- Progression free survival
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients older than 18 years and less than 70 years * Histologically-proven Gleason 7 adenocarcinoma of the prostate * pT2a or pT2b disease based on biopsies of the prostate * More than 2/3 of positive biopsies or 15 ≤ serum PSA \<20 * No previous carcinoma, except basal-cell carcinoma of the skin * Adequate renal function: measured or calculated creatinine clearance\> 60 ml/min * Absolute granulocyte count ≥ 1,500/mm3, platelets ≥ 100,000 mm3, bilirubin ≤ 1.5 fold the upper normal value * Signed informed consent. Exclusion Criteria: * Patients infected by the Human Immunodeficiency Virus (HIV) * Contra-indication to general anesthesia or surgery * Patients who do not fit inclusion criteria
References
Publications (0)
Data not yet available
No reference posted for this study.