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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology Identifier:
First received: November 1, 1999
Last updated: July 7, 2015
Last verified: July 2015

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
Other: mutation analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Androgen Receptor Mutations in Hormone Refractory Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • overall survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • response rate [ Time Frame: Up to 10 years ]

Biospecimen Retention:   Samples With DNA
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).

Enrollment: 184
Study Start Date: January 1997
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Source of patient samples
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).
Other: mutation analysis

Detailed Description:


  1. the feasibility of collecting bone marrow biopsies from prostate cancer patients in a cooperative group setting
  2. the incidence of marrow invasion by prostate tumor in random bone marrow biopsy
  3. the influence of previous prostate radiation on obtaining prostate tumor
  4. the frequency and type of AR mutations and
  5. association of AR mutations with response to antiandrogen withdrawal.

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible men enrolled on a trial of antiandrogen withdrawal had a minimum prostate-specific antigen (PSA) level of 5 ng/dL that was increasing on castration therapy including an antiandrogen. Marrow biopsies were obtained to collect prostate tumor. Additional samples were obtained from men enrolled on chemotherapy trials.
  1. Histologically proven adenocarcinoma of the prostate that is refractory to hormone therapy
  2. 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00002924

  Show 49 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Mary-Ellen Taplin, MD University of Massachusetts, Worcester
  More Information

Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00002924     History of Changes
Other Study ID Numbers: CALGB-9663  U10CA031946  CDR0000065329 
Study First Received: November 1, 1999
Last Updated: July 7, 2015
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
adenocarcinoma of the prostate
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms processed this record on February 10, 2016