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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | January 30, 2007 | ||||||||||||
| Last Updated Date | March 18, 2010 | ||||||||||||
| Start Date ICMJE | December 2006 | ||||||||||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
3-year biochemical progression-free survival (bPFS) rate [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE |
3-year biochemical progression-free survival rate (bPFS) | ||||||||||||
| Change History | Complete list of historical versions of study NCT00430183 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer | ||||||||||||
| Official Title ICMJE | Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients With High-Risk, Clinically Localized Prostate Cancer | ||||||||||||
| 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. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin and leuprolide, may stop the adrenal glands from making androgens. Giving docetaxel and leuprolide or goserelin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether giving docetaxel and leuprolide or goserelin before surgery is more effective than surgery alone in treating patients with prostate cancer. PURPOSE: This randomized phase III trial is studying docetaxel and leuprolide or goserelin to see how well they work when given before surgery compared with surgery alone in treating patients with high-risk localized prostate cancer. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to nomogram-predicted biochemical progression-free survival at 5 years (0-20.9% vs 21-39.9% vs 40-59.9% vs ≥ 60%) and androgen-deprivation therapy in the past 3 months (no vs yes). Patients are randomized to 1 of 2 treatment arms.
After completion of study therapy, patients are followed at 1 and 3 months and then periodically for up to 15 years. PROJECTED ACCRUAL: A total of 750 patients will be accrued for this study. |
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| Study Phase | Phase III | ||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Primary Purpose: Treatment |
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| Condition ICMJE | Prostate Cancer | ||||||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 750 | ||||||||||||
| Completion Date | |||||||||||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Male | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | |||||||||||||
| Location Countries ICMJE | United States, Canada | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00430183 | ||||||||||||
| Responsible Party | Richard L. Schilsky, Cancer and Leukemia Group B | ||||||||||||
| Study ID Numbers ICMJE | CDR0000526353, CALGB-90203 | ||||||||||||
| Study Sponsor ICMJE | Cancer and Leukemia Group B | ||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||||||
| Verification Date | March 2010 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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