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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00127088
Recruitment Status : Suspended
First Posted : August 5, 2005
Last Update Posted : September 11, 2006
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Drug: docetaxel Procedure: laparoscopic radical prostatectomy Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Docetaxel

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

Secondary Outcome Measures :
  1. Toxicity
  2. Pathological response rate
  3. Progression free survival
  4. Overall survival

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00127088

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Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
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Principal Investigator: Karim Fizazi, Dr Gustave Roussy, Cancer Campus, Grand Paris

Layout table for additonal information Identifier: NCT00127088    
Other Study ID Numbers: Peri-op
First Posted: August 5, 2005    Key Record Dates
Last Update Posted: September 11, 2006
Last Verified: September 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:
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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