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

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

Status

Suspended

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00127088

Enrollment

Registered

2005-08-05

Start date

2004-10-31

Completion date

Unknown

Last updated

2006-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

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

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.

Interventions

DRUGdocetaxel

PROCEDURElaparoscopic radical prostatectomy

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Complete prostate specific antigen (PSA) response rate	—

Secondary

Measure	Time frame
Toxicity	—
Pathological response rate	—
Progression free survival	—
Overall survival	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026