Gene Mutations in Patients With Advanced Prostate Cancer That Is Not Responsive to Hormone Therapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002924
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: August 2006
  Purpose

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.


Condition Intervention
Prostate Cancer
Genetic: mutation analysis

Study Type: Observational
Official Title: Androgen Receptor Mutations in Hormone Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 243
Study Start Date: January 1997
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002924

  Show 49 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Mary-Ellen Taplin, MD University of Massachusetts, Worcester
  More Information

Additional Information:
Publications:
Taplin ME, Halabi S, Rajeshkumar B, et al.: Androgen receptor mutations in androgen independent prostate cancer (APICA) do not correlate with anti-androgen withdrawal response: Cancer and Leukemia Group B (CALGB) 9663. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1738, 2001.
Taplin ME, Rajeskumar B, Woda BA, et al.: Androgen receptor analyses in androgen independent prostate cancer (AIPCA): Cancer and Leukemia Group B (CALGB) 9663. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A1297, 2000.

ClinicalTrials.gov Identifier: NCT00002924     History of Changes
Other Study ID Numbers: CDR0000065329, CLB-9663
Study First Received: November 1, 1999
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014