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.
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 Type
OBSERVATIONAL
one time lapb-band gastric bypass surgery
Maimonides Medical Center
Brooklyn, New York, United States
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.
Time frame: 18 months
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
Time frame: 18 months
Effect of Lapband-induced weight loss on sexual function
Measured using EPIC and Sexual Health Inventory for Men (SHIM)
Time frame: 18 months
Effect of Lapband-induced weight loss on prostate size and associated urinary symptoms
Measured using EPIC and the International Prostate Symptom Score (IPSS)
Time frame: 18 months
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)
Time frame: 18 months
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