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Sponsored by: |
Scandinavian Prostate Cancer Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00376792 |
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 | Intervention | Phase |
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Prostate Cancer |
Drug: docetaxel Procedure: adjuvant therapy Procedure: observation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, 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 |
Estimated Enrollment: | 396 |
Study Start Date: | October 2005 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Quality of life is assessed at baseline, directly after and 6 months after completing study treatment, and then 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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate meeting one of the following criteria after undergoing radical prostatectomy:
No metastatic (M0) disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Denmark | |
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 lise@herlevhosp.kbhamt.dk | |
Finland | |
Tampere University Hospital | Recruiting |
Tampere, Finland, 33521 | |
Contact: Pirkko Kellokumpu-Lehtinen 358-3-247-3227 pirkko-liisa.kellokumpu-lehtinen@uta.fi | |
Iceland | |
Landspitalinn University Hospital | Recruiting |
Reykjavik, Iceland, 125 | |
Contact: Asgerdur Sverrisdottir, MD 354-543-1000 asgerds@landspitali.is | |
Norway | |
Norwegian University of Science and Technology | Recruiting |
Trondheim, Norway, N-7005 | |
Contact: Anders Angelsen, MD, PhD 47-73-868-000 | |
Ullevaal University Hospital | Recruiting |
Oslo, Norway, 0407 | |
Contact: Jon R. Iversen, MD 47-22-119-310 joiv@uus.no | |
Sweden | |
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 goran.ahlgren@skane.se |
Study Chair: | Goran Ahlgren, MD, PhD | Malmo University Hospital |
Investigator: | Per Flodgren, MD, PhD | Lund University Hospital |
Study ID Numbers: | CDR0000456773, SPCG-12, EUDRACT-2005-002355-40, EU-20638, SANOFI-AVENTIS-SPCG-12, SPCG-ADPRO |
Study First Received: | September 13, 2006 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00376792 |
Health Authority: | Unspecified |
stage II prostate cancer stage III prostate cancer adenocarcinoma of the prostate |
Docetaxel Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |