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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00161252
First received: September 8, 2005
Last updated: May 9, 2011
Last verified: May 2011
  Purpose

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.


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Assessment of Primary Androgen Deprivation Therapy for Non-metastatic Prostate Cancer Among Elderly Men

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Enrollment: 0
Study Start Date: March 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

To compare overall and prostate cancer specific survival among elderly patients receiving primary androgen deprivation therapy and conservative management for non-metastatic prostate cancer diagnosed in 1992-1999

Criteria

Inclusion criteria:

  • Diagnosed at age 75 or older.
  • Diagnosed with non-metastatic prostate cancer in 1992-1999.
  • Enrolled in Medicare for the 12 months before diagnosis for an adequate assessment of baseline comorbidity.
  • Enrolled in Medicare Part A and Part B through death or the end of the study period to have an adequate claim history of cancer treatment over the follow-up period.
  • Alive for at least 6 months after cancer diagnosis. This criterion will remove men who are diagnosed at death or who are dying and have severe comorbidities, and are therefore poor candidates for 'aggressive' cancer interventions.

Exclusion criteria:

  • Enrolled in Medicare managed care plans during the study period since no Medicare claims are available during the period of enrollment.
  • Have other types of cancer. This criterion will ensure that all cancer therapies identified from the Medicare claims are for prostate cancer exclusively.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161252

Locations
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Grace Lu-Yao, PhD Rutgers, The State University of New Jersey
  More Information

No publications provided

Responsible Party: Grace Lu-Yao, PhD, Cancer Institute of New Jersey
ClinicalTrials.gov Identifier: NCT00161252     History of Changes
Other Study ID Numbers: 5276, 080501
Study First Received: September 8, 2005
Last Updated: May 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014