Docetaxel Compared With Observation in Treating Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00376792|
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : September 15, 2006
Last Update Posted : August 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: docetaxel Other: active surveillance Procedure: adjuvant therapy||Phase 3|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||396 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2005|
|Estimated Primary Completion Date :||December 2012|
- Prostate-specific antigen (PSA) progression
- PSA doubling time
- Quality of Life
- Metastasis-free survival
- Overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376792
|Aarhus Universitetshospital - Aarhus Sygehus||Recruiting|
|Aarhus, Denmark, DK 8200|
|Contact: Michael Borre, MD, PhD, DMsci 45-89-495-566|
|Copenhagen County Herlev University Hospital||Recruiting|
|Copenhagen, Denmark, DK-2730|
|Contact: Lisa Sengelov, MD, PhD 45-44-884-488 firstname.lastname@example.org|
|Tampere University Hospital||Recruiting|
|Tampere, Finland, 33521|
|Contact: Pirkko Kellokumpu-Lehtinen 358-3-247-3227 email@example.com|
|Landspitalinn University Hospital||Recruiting|
|Reykjavik, Iceland, 125|
|Contact: Asgerdur Sverrisdottir, MD 354-543-1000 firstname.lastname@example.org|
|Ullevaal University Hospital||Recruiting|
|Oslo, Norway, 0407|
|Contact: Jon R. Iversen, MD 47-22-119-310 email@example.com|
|Norwegian University of Science and Technology||Recruiting|
|Trondheim, Norway, N-7005|
|Contact: Anders Angelsen, MD, PhD 47-73-868-000|
|Lund University Hospital||Recruiting|
|Lund, Sweden, SE-22185|
|Contact: Per Flodgren, MD, PhD 46-46-177-520|
|Malmo University Hospital||Recruiting|
|Malmo, Sweden, S-20502|
|Contact: Goran Ahlgren, MD, PhD 46-40-33-3754 firstname.lastname@example.org|
|Study Chair:||Goran Ahlgren, MD, PhD||Skane University Hospital|
|OverallOfficial:||Per Flodgren, MD, PhD||Lund University Hospital|