Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer
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ClinicalTrials.gov Identifier: NCT00430183 |
Recruitment Status
:
Active, not recruiting
First Posted
: February 1, 2007
Last Update Posted
: June 27, 2017
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Tracking Information | ||||
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First Submitted Date ICMJE | January 30, 2007 | |||
First Posted Date ICMJE | February 1, 2007 | |||
Last Update Posted Date | June 27, 2017 | |||
Study Start Date ICMJE | December 2006 | |||
Estimated Primary Completion Date | June 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
3-year biochemical progression-free survival (bPFS) rate [ Time Frame: 3 years ] | |||
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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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
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 | A 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 | This randomized trial tests whether the addition of chemohormonal therapy improves PSA-progression free survival in patients with high risk, clinically-localized prostate cancer. The neoadjuvant approach is taken since there appears to be a higher acceptance rate in the prostate population for this type of therapy and several phase II trials have demonstrated its safety. Multiple chemotherapeutic therapies have shown efficacy in advanced prostate cancer and docetaxel has become the community standard. Many high risk patients are initiated on LHRH agonists at or near the time of diagnosis of their prostate cancer. In order to allow the inclusion of these patients in the protocol, enhanced enrollment and maintain compliance with therapy, up to 3 months of androgen deprivation therapy prior to enrollment will be permitted. This study will therefore be able to test the hypothesis that targeting both androgen-sensitive and chemotherapy- sensitive prostate cancer cells will improve outcomes in these high-risk patients. 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 prior to randomization ≤ 4 months (no vs yes). Patients are randomized to 1 of 2 treatment arms. Please see the Arms sections for more details. The primary and secondary objectives are described below. Primary: - To determine whether treatment with neoadjuvant docetaxel and androgen deprivation therapy prior to radical prostatectomy will increase the rate of 3-year biochemical progression-free survival (bPFS) compared to treatment with immediate radical prostatectomy alone for high-risk prostate cancer patients. Secondary:
Patients are followed up to 15 years post-randomization. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Prostate Cancer | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
788 | |||
Original Enrollment ICMJE |
750 | |||
Study Completion Date | Not Provided | |||
Estimated Primary Completion Date | June 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE |
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada, United States | |||
Removed Location Countries | Peru | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00430183 | |||
Other Study ID Numbers ICMJE | CALGB 90203 U10CA031946 ( U.S. NIH Grant/Contract ) CDR0000526353 ( Other Identifier: Physician Data Query ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Alliance for Clinical Trials in Oncology | |||
Study Sponsor ICMJE | Alliance for Clinical Trials in Oncology | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Alliance for Clinical Trials in Oncology | |||
Verification Date | June 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |