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| Tracking Information | |||||
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| First Received Date ICMJE | November 1, 1999 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | January 1997 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00002924 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Gene Mutations in Patients With Advanced Prostate Cancer That Is Not Responsive to Hormone Therapy | ||||
| Official Title ICMJE | Androgen Receptor Mutations in Hormone Refractory Prostate Cancer | ||||
| Brief Summary | RATIONALE: Gene mutations may make prostate cancer cells unable to attach to androgens. This may permit the growth of prostate cancer. Gene testing may improve the identification of patients with advanced prostate cancer. PURPOSE: Clinical trial to study the androgen receptor gene in patients with prostate cancer that is not responsive to hormone therapy. |
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| Detailed Description | OBJECTIVES: I. Test the feasibility of obtaining bone marrow specimens in a cooperative group setting. II. Determine the frequency of bone marrow invasion by prostate cancer cells in patients with hormone refractory prostate cancer. III. Evaluate the frequency of androgen receptor (AR) mutations in bone marrow samples in this patient population. IV. Evaluate the association between AR mutations and clinical outcomes, including survival, and response to therapy, such as antiandrogen withdrawal. V. Evaluate the impact of prior pelvic radiotherapy on the ability to obtain informative tissue. OUTLINE: Blood and a bone marrow biopsy are collected from each patient before the patient begins treatment on CLB-9480 or CLB-9583. The specimens are analyzed for androgen receptor mutations. Patients do not receive results of the genetic testing and the results do not influence the type or duration of treatment. PROJECTED ACCRUAL: A total of 243 patients will be accrued for this study. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | |||||
| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE | Genetic: mutation analysis | ||||
| Study Arms / Comparison Groups | |||||
| 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 | Completed | ||||
| Estimated Enrollment ICMJE | 243 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the prostate that is refractory to hormone therapy Eligible for any prostate cancer chemotherapy protocol, but have not started treatment Patients who are eligible for anticancer therapy on Protocol CLB-9480, CLB-9583, CLB-9680, or CLB-9780 are also eligible for this study if they have not started treatment on those protocols PATIENT CHARACTERISTICS: Age: Any age Performance status: CALGB 0-2 Life expectancy: See Disease Characteristics Hematopoietic: See Disease Characteristics Hepatic: See Disease Characteristics Renal: See Disease Characteristics PRIOR CONCURRENT THERAPY: See Disease Characteristics |
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| Gender | Male | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00002924 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000065329, CLB-9663 | ||||
| Study Sponsor ICMJE | Cancer and Leukemia Group B | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | August 2006 | ||||
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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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