Docetaxel Compared With Observation in Treating Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer

Prostate Cancer Clinical Trial

Official title: An Open Randomized Phase III Trial of Six Cycles of Docetaxel Versus Surveillance After Radical Prostatectomy in High Grade Prostate Cancer Patients With Margin Positive T2 or T3 Tumours

Status Recruiting

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving docetaxel after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving docetaxel after surgery is more effective than observation in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying docetaxel to see how well it works compared with observation in treating patients who have undergone radical prostatectomy for prostate cancer.

Clinical Trial Description

OBJECTIVES:

Primary

• Compare time to prostate-specific antigen (PSA) progression in patients with margin-positive tumors after undergoing radical prostatectomy for high-grade prostate cancer treated with docetaxel versus observation.

Secondary

• Compare PSA doubling time in patients treated with these regimens.

• Compare quality of life of these patients.

• Compare overall and metastasis-free survival of patients treated with these regimens.

OUTLINE: This is a prospective, open-label, randomized, multicenter study. Patients are stratified according to participating center and tumor stage (pT2 vs pT3). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, directly after and 6 months after completing study treatment, and then annually thereafter.

• Arm II: Patients undergo observation until PSA progression (defined as PSA ≥ 0.5 ng/mL) Quality of life is assessed at baseline, week 19, and annually thereafter.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 396 patients will be accrued for this study. ;

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00376792
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Recruiting
• Phase: Phase 3
• Start date: October 2005