Gene Mutations in Patients With Advanced Prostate Cancer That Is Not Responsive to Hormone Therapy - Full Text View

Sponsors and Collaborators:	Cancer and Leukemia Group B National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002924

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:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

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

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

Show 49 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Mary-Ellen Taplin, MD

UMASS Memorial Cancer Center - University Campus

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Ross RW, Halabi S, Ou SS, Rajeshkumar BR, Woda BA, Vogelzang NJ, Small EJ, Taplin ME, Kantoff PW; Cancer and Leukemia Group B. Predictors of prostate cancer tissue acquisition by an undirected core bone marrow biopsy in metastatic castration-resistant prostate cancer--a Cancer and Leukemia Group B study. Clin Cancer Res. 2005 Nov 15;11(22):8109-13.

Taplin ME, Rajeshkumar B, Halabi S, Werner CP, Woda BA, Picus J, Stadler W, Hayes DF, Kantoff PW, Vogelzang NJ, Small EJ; Cancer and Leukemia Group B Study 9663. Androgen receptor mutations in androgen-independent prostate cancer: Cancer and Leukemia Group B Study 9663. J Clin Oncol. 2003 Jul 15;21(14):2673-8.

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.

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

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
recurrent prostate cancer

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma

Hormones
Prostatic Neoplasms
Recurrence
Androgens

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009