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

Phase 3

• Conditions: Prostate Cancer

• Registration Number: NCT00376792
• Lead Sponsor: Scandinavian Prostate Cancer Group

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-09-13
• Study First Submitted QC: 2006-09-13
• Study First Posted: 2006-09-15
• Status Verified: 2009-06
• Primary Completion: 2012-12
• Last Update Submitted: 2013-08-23
• Last Update Posted: 2013-08-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 396

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prostate-specific antigen (PSA) progression

Secondary Outcome Measures

Name	Time	Method
Overall survival
Quality of Life
Metastasis-free survival
PSA doubling time

Trial Locations

Locations (8)

Lund University Hospital; 🇸🇪 Lund, Sweden

Aarhus Universitetshospital - Aarhus Sygehus; 🇩🇰 Aarhus, Denmark

Malmo University Hospital; 🇸🇪 Malmo, Sweden

Landspitalinn University Hospital; 🇮🇸 Reykjavik, Iceland

Ullevaal University Hospital; 🇳🇴 Oslo, Norway

Copenhagen County Herlev University Hospital; 🇩🇰 Copenhagen, Denmark

Tampere University Hospital; 🇫🇮 Tampere, Finland

Norwegian University of Science and Technology; 🇳🇴 Trondheim, Norway