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

Withdrawn

• Conditions: Prostate Cancer

• Registration Number: NCT00161252
• Lead Sponsor: University of Medicine and Dentistry of New Jersey

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-12
• Primary Completion: 2008-11
• Study Completion: 2008-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States