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.
|Official Title:||Androgen Receptor Mutations in Hormone Refractory Prostate Cancer|
|Study Start Date:||January 1997|
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.
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|