Obesity, Prostate Cancer
Conditions
Keywords
obesity, psa, prostate cancer
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.
Interventions
OTHERBariatric Surgery
one time lapb-band gastric bypass surgery
Sponsors
Maimonides Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
20 Years to 60 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Effect of Lapband-induced weight loss on sexual function | 18 months | Measured using EPIC and Sexual Health Inventory for Men (SHIM) |
| 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) |
| 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) |
Countries
United States
Outcome results
None listed