Effect of Lap-Band Induced Weight Loss on Serum PSA Levels

Withdrawn

• Conditions: Prostate Cancer; Obesity
• Interventions: Other: Bariatric Surgery

• Registration Number: NCT00562341
• Lead Sponsor: Maimonides Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-20
• Study First Submitted QC: 2007-11-21
• Study First Posted: 2007-11-22
• Primary Completion: 2009-12-31
• Study Completion: 2009-12-31
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-21
• Last Update Posted: 2018-08-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
bariatric surgery	Bariatric Surgery	description of enrollees

Primary Outcome Measures

Name	Time	Method
Prostate-Specific Antigen (PSA) value	18 months	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.

Secondary Outcome Measures

Name	Time	Method
Effect of Lapband-induced weight loss on quality of life	18 months	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
Receiver Operating Curve (ROC) analysis to evaluate PSA cancer detection performance	18 months	ROC analysis - prostate cancer vs. no prostate cancer (1-specificity vs. sensitivity for all cutoff values in the range of all PSA levels observed)
Effect of Lapband-induced weight loss on prostate size and associated urinary symptoms	18 months	Measured using EPIC and the International Prostate Symptom Score (IPSS)
Effect of Lapband-induced weight loss on sexual function	18 months	Measured using EPIC and Sexual Health Inventory for Men (SHIM)

Trial Locations

Locations (1)

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States