Assessment of Primary Androgen Deprivation Therapy for Non-metastatic Prostate Cancer Among Elderly

NCT00161252 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2021-09-27

No results posted yet for this study

Summary

The widespread availability of screening coupled with high risks of over diagnosis, over treatment, and a rising risk of dying from competing causes of deaths pose a major challenge for prostate cancer patients and our health care system. Data on outcomes and identification of patients who are likely to benefit from therapies are urgently needed to empower patients and health professionals and to allocate limited health resources wisely. The long-term goal of this population-based study is to improve prostate cancer care for elderly patients. In 2004, approximately thirty percent of the 230,110 new prostate cancer cases diagnosed will be in men over age 75. Elderly men have a high risk of being diagnosed with prostate cancer, but a relatively low risk of dying of this disease, and are often excluded from cancer trials. While the value of primary androgen deprivation for localized prostate cancer remains questionable, this treatment is widely used among elderly patients. Currently, there is insufficient outcomes data to guide treatment choices for elderly patients.The following are the key background considerations that provide the rationale for this proposed project:· Prostate cancer is prevalent among elderly men. · Over diagnosis and competing causes of death are important issues for elderly men with prostate cancer.· Androgen deprivation therapy (ADT) is being increasingly used as primary therapy among elderly patients with localized disease· There are insufficient outcomes data to support the use of primary androgen deprivation for non metastatic prostate cancer· Preliminary dataThe study population in this sub-project is a sub-sample of the large study (IRB # 5177 ) and the research methods are identical in both studies.

Conditions

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED
  • University of Medicine and Dentistry of New Jersey

    lead OTHER

Principal Investigators

  • Grace Lu-Yao, PhD · Rutgers, The State University of New Jersey

Eligibility

Min Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2008-11-30
Completion
2008-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00161252 on ClinicalTrials.gov