Gene Mutations in Patients With Advanced Prostate Cancer That Is Not Responsive to Hormone Therapy
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Androgen Receptor Mutations in Hormone Refractory Prostate Cancer|
Bone marrow biopsies were obtained from 164 patients enrolled on CALGB 9583 and from 20 patients enrolled on CALGB chemotherapy trials (CALGB 9480, 9680, 9780).
|Study Start Date:||January 1997|
|Study Completion Date:||June 2006|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
- the feasibility of collecting bone marrow biopsies from prostate cancer patients in a cooperative group setting
- the incidence of marrow invasion by prostate tumor in random bone marrow biopsy
- the influence of previous prostate radiation on obtaining prostate tumor
- the frequency and type of AR mutations and
- association of AR mutations with response to antiandrogen withdrawal.
The CALGB conducted a phase III study (CALGB 9583) in which 260 men with AiPC were randomly assigned to antiandrogen withdrawal together with simultaneous ketoconazole and hydrocortisone versus antiandrogen withdrawal alone, followed by sequential ketoconazole and hydrocortisone. Metastatic disease with progression despite castrate levels of testosterone, prior antiandrogen therapy for a minimum of 4 weeks, and a minimum PSA level of 5 ng/mL were required; treatment with sequential antiandrogens was allowed. No prior chemotherapy was allowed. Bone marrow biopsies were obtained from 164 patients enrolled on CALGB 9583 and from 20 patients enrolled on CALGB chemotherapy trials (CALGB 9480, 9680, 9780).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002924
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|Study Chair:||Mary-Ellen Taplin, MD||University of Massachusetts, Worcester|