Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161252
Status:
WITHDRAWN
Last Update Posted:
2021-09-27
First Post:
2005-09-08
Brief Title:
Assessment of Primary Androgen Deprivation Therapy for Non-metastatic Prostate Cancer Among Elderly
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Assessment of Primary Androgen Deprivation Therapy for Non-metastatic Prostate Cancer Among Elderly Men
Status:
WITHDRAWN
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 230110 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 patientsThe 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 080501 | None | None | None |