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

Androgen Receptor Mutations in Hormone Refractory Prostate Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00002924
Enrollment
184
Registered
2004-05-24
Start date
1997-01-31
Completion date
2006-06-30
Last updated
2016-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate, recurrent prostate cancer

Brief summary

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.

Detailed 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.

Interventions

OTHERmutation analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
overall survivalUp to 10 years

Secondary

MeasureTime frame
response rateUp to 10 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026