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

This study has been suspended.

First Received: August 3, 2005 Last Updated: September 7, 2006 History of Changes

Sponsored by:	Institut Gustave Roussy
Information provided by:	Institut Gustave Roussy
ClinicalTrials.gov Identifier:	NCT00127088

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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:

MedlinePlus related topics: Cancer Prostate Cancer

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

Study ID Numbers:	Peri-op
Study First Received:	August 3, 2005
Last Updated:	September 7, 2006
ClinicalTrials.gov Identifier:	NCT00127088 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut Gustave Roussy:

Patients with localized Gleason 7 pT2a-pT2b adenocarcinoma of the prostate

Study placed in the following topic categories:

Docetaxel
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms

Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:

Docetaxel
Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Antineoplastic Agents

Therapeutic Uses
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009