Obesity Clinical Trial
Official title:
Effect of Lap-Band Induced Weight Loss on Serum PSA Levels, Testosterone, Estrogen and Other Serum Markers
NCT number | NCT00562341 |
Other study ID # | 07/09/VA18 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | November 2007 |
Est. completion date | December 31, 2009 |
Verified date | August 2018 |
Source | Maimonides Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The proposed prospective study aims to determine whether interpretation of PSA levels in morbidly obese men require correction due to the obesity itself. If PSA levels are found to rise after weight loss, interpretation of PSA levels in morbidly obese men may be improved by upward correction of the PSA level. A 'correction factor' may be proposed for the interpretation of PSA levels in obese men, toward the clinical decision regarding indication for prostate biopsy.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 31, 2009 |
Est. primary completion date | December 31, 2009 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 20 Years to 60 Years |
Eligibility |
Inclusion Criteria: - obese men undergoing lap-band surgery Exclusion Criteria: - prior diagnosis of prostate cancer - prior prostate surgery - use of 5-alpha reductase inhibitors - history of prostatitis - recurrent Urinary Tract Infection (UTI). |
Country | Name | City | State |
---|---|---|---|
United States | Maimonides Medical Center | Brooklyn | New York |
Lead Sponsor | Collaborator |
---|---|
Maimonides Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prostate-Specific Antigen (PSA) value | The PSA serum test measures the level of PSA in a man's blood. The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood. | 18 months | |
Secondary | Effect of Lapband-induced weight loss on quality of life | Measured using the Expanded Prostate Cancer Index Composite (EPIC). The EPIC for Clinical Practice (EPIC-CP) is a one-page, 16-item questionnaire to measure urinary incontinence, urinary irritation, bowel, sexual, and hormonal HRQOL domains | 18 months | |
Secondary | Effect of Lapband-induced weight loss on sexual function | Measured using EPIC and Sexual Health Inventory for Men (SHIM) | 18 months | |
Secondary | Effect of Lapband-induced weight loss on prostate size and associated urinary symptoms | Measured using EPIC and the International Prostate Symptom Score (IPSS) | 18 months | |
Secondary | Receiver Operating Curve (ROC) analysis to evaluate PSA cancer detection performance | ROC analysis - prostate cancer vs. no prostate cancer (1-specificity vs. sensitivity for all cutoff values in the range of all PSA levels observed) | 18 months |
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