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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


Phase 2
18 Years
70 Years
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete prostate specific antigen (PSA) response rate

Principal Investigator

Karim Fizazi, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

Peri-op

NCT ID:

NCT00127088

Start Date:

October 2004

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Patients with localized Gleason 7 pT2a-pT2b adenocarcinoma of the prostate
  • Adenocarcinoma
  • Prostatic Neoplasms

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