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

Study Overview
=================
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.

Official Title
-----------------
Effect of Lap-Band Induced Weight Loss on Serum PSA Levels, Testosterone, Estrogen and Other Serum Markers

Conditions
-----------------
Obesity, Prostate Cancer

Intervention / Treatment
-----------------
* Other: Bariatric Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| bariatric surgery<br>description of enrollees | Other: Bariatric Surgery<br>* one time lapb-band gastric bypass surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Effect of Lapband-induced weight loss on sexual function | Measured using EPIC and Sexual Health Inventory for Men (SHIM) | 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) | 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) | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, psa, prostate cancer