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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00127088
• Other study ID #: Peri-op
• Status: Suspended
• Phase: Phase 2
• First received: August 3, 2005
• Last updated: September 7, 2006
• Start date: October 2004

Study information

• Verified date: September 2006
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 37
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• docetaxel

Procedure:
• laparoscopic radical prostatectomy

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete prostate specific antigen (PSA) response rate
Secondary	Toxicity
Secondary	Pathological response rate
Secondary	Progression free survival
Secondary	Overall survival