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

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Prostate Cancer

Treatments: Other: mutation analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00002924

U10CA031946 (U.S. NIH Grant/Contract)

CDR0000065329 (Registry Identifier)

CALGB-9663

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

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.

Enrollment: 184 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

184 participants in 1 patient group

Source of patient samples

Description:

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).

Treatment:

Other: mutation analysis