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OpenTrials
Completed

NCT Number: NCT00002924

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

Veterans Affairs Medical Center - Birmingham, Birmingham, Alabama, United States

Loading trial locations.

About this study

OBJECTIVES:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Histologically proven adenocarcinoma of the prostate that is refractory to hormone therapy
  • 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

Treatment and study plan

mutation analysis

Other

Primary outcomes

  1. overall survival

    Time frame: Up to 10 years

Secondary outcomes

  1. response rate

    Time frame: Up to 10 years

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Androgen Receptor Mutations in Hormone Refractory Prostate Cancer

Important dates

Study start
1997
Primary completion
2006
Study completion
2006
First posted
May 24, 2004
Registry last updated
Jul 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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