Expired Study
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New Brunswick, New Jersey 08901


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.


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.


Study is Available At:


Original ID:

5276


NCT ID:

NCT00161252


Secondary ID:

080501


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Withdrawn


Study Phase:

N/A


Genders:

Male


Minimum Age:

75 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Rutgers, The State University of New Jersey


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Ecologic or Community, Time P


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Grace Lu-Yao, PhD
Principal Investigator
Rutgers, The State University of New Jersey

Study Dates

Start Date:March 2005
Completion Date:December 2008
Completion Type:Actual
Primary Completion Date:November 2008
Primary Completion Type:Actual
Verification Date:May 2011
Last Changed Date:May 27, 2015
First Received Date:September 8, 2005

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Medicine and Dentistry of New Jersey
Agency Class:U.S. Fed
Agency Type:Collaborator
Agency Name:Department of Defense

Samples and Retentions

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
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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