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Study of Peri-Operative Docetaxel Plus Laparoscopic Radical Prostatectomy in Prostate Cancer Patients

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Institut Gustave Roussy
ClinicalTrials.gov Identifier:
NCT00127088
First received: August 3, 2005
Last updated: September 7, 2006
Last verified: September 2006
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
 Drug: docetaxel
Procedure: laparoscopic radical prostatectomy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Docetaxel
U.S. FDA Resources

Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:
  • Complete prostate specific antigen (PSA) response rate

Secondary Outcome Measures:
  • Toxicity
  • Pathological response rate
  • Progression free survival
  • Overall survival

Estimated Enrollment: 37
Study Start Date: October 2004
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127088

Locations
France
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Institut Gustave Roussy
Investigators
Principal Investigator: Karim Fizazi, Dr Institut Gustave Roussy
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00127088     History of Changes
Other Study ID Numbers: Peri-op
Study First Received: August 3, 2005
Last Updated: September 7, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Gustave Roussy:
Patients with localized Gleason 7 pT2a-pT2b adenocarcinoma of the prostate

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013