NCT00127088

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
37

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2005

Completed
Last Updated

September 11, 2006

Status Verified

September 1, 2006

First QC Date

August 3, 2005

Last Update Submit

September 7, 2006

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Complete prostate specific antigen (PSA) response rate

Secondary Outcomes (4)

  • Toxicity

  • Pathological response rate

  • Progression free survival

  • Overall survival

Interventions

docetaxelDRUG
laparoscopic radical prostatectomyPROCEDURE

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients infected by the Human Immunodeficiency Virus (HIV)
  • Contra-indication to general anesthesia or surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Karim Fizazi, Dr

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 3, 2005

First Posted

August 5, 2005

Study Start

October 1, 2004

Last Updated

September 11, 2006

Record last verified: 2006-09

Locations

FR(1)