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

This study has suspended participant recruitment.
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris Identifier:
First received: August 3, 2005
Last updated: September 7, 2006
Last verified: September 2006
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
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:

Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

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

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00127088

Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Principal Investigator: Karim Fizazi, Dr Gustave Roussy, Cancer Campus, Grand Paris
  More Information Identifier: NCT00127088     History of Changes
Other Study ID Numbers: Peri-op
Study First Received: August 3, 2005
Last Updated: September 7, 2006

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Patients with localized Gleason 7 pT2a-pT2b adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017