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

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Primary Purpose

Status

Suspended

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

docetaxel

laparoscopic radical prostatectomy

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Patients with localized Gleason 7 pT2a-pT2b adenocarcinoma of the prostate

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Institut Gustave Roussy

Outcomes

Primary Outcome Measures

Complete prostate specific antigen (PSA) response rate

Secondary Outcome Measures

Toxicity

Pathological response rate

Progression free survival

Overall survival

Full Information

NCT ID

NCT00127088

First Posted

August 3, 2005

Last Updated

September 7, 2006

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

1. Study Identification

Unique Protocol Identification Number

NCT00127088

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2006

Overall Recruitment Status

Suspended

Study Start Date

October 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

37 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

docetaxel

Intervention Type

Procedure

Intervention Name(s)

laparoscopic radical prostatectomy

Primary Outcome Measure Information:

Title

Complete prostate specific antigen (PSA) response rate

Secondary Outcome Measure Information:

Title

Toxicity

Title

Pathological response rate

Title

Progression free survival

Title

Overall survival

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karim Fizazi, Dr

Organizational Affiliation

Gustave Roussy, Cancer Campus, Grand Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut Gustave Roussy

City

Villejuif

ZIP/Postal Code

94805

Country

France

Prostate Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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