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Clinical Trial Details — Status: Withdrawn

Administrative data

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Status Withdrawn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

Study information

Verified date August 2018
Source Maimonides Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

The main objective of this study is to determine whether interpretation of PSA levels in morbidly obese men require correction due to the obesity itself. Secondary outcome measures that will be followed include the affect of obesity and weight loss on testosterone, estradiol and leptin. In as much as these might also affect PSA, we will be measuring these values as well. Also, we do not know the effects of lap-band induced weight loss on clinical outcome measures of sexual, bowel and urinary function. Thus we will aim to investigate these parameters as well.


Recruitment information / eligibility

Status Withdrawn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).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Bariatric Surgery
one time lapb-band gastric bypass surgery

Locations

Country Name City State
United States Maimonides Medical Center Brooklyn New York

Sponsors (1)

Lead Sponsor Collaborator
Maimonides Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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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