- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00161252
Assessment of Primary Androgen Deprivation Therapy for Non-metastatic Prostate Cancer Among Elderly
September 20, 2021 updated by: University of Medicine and Dentistry of New Jersey
Assessment of Primary Androgen Deprivation Therapy for Non-metastatic Prostate Cancer Among Elderly Men
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.
Study Overview
Status
Withdrawn
Conditions
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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New Brunswick, New Jersey, United States, 08901
- Cancer Institute of New Jersey
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
75 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
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
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Retrospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Grace Lu-Yao, PhD, Rutgers, the State University of New Jersey
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 11, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Actual)
September 27, 2021
Last Update Submitted That Met QC Criteria
September 20, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0220055276
- 080501
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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