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

Sponsored by:	Maimonides Medical Center
Information provided by:	Maimonides Medical Center
ClinicalTrials.gov Identifier:	NCT00562341

Purpose

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.

Condition	Intervention
Obesity Prostate Cancer	Procedure: Bariatric Surgery

MedlinePlus related topics: Cancer Obesity Prostate Cancer Weight Control Weight Loss Surgery

Drug Information available for: Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Effect of Lap-Band Induced Weight Loss on Serum PSA Levels, Testosterone, Estrogen and Other Serum Markers

Further study details as provided by Maimonides Medical Center:

Primary Outcome Measures:

PSA value [ Time Frame: 18 months ]

Secondary Outcome Measures:

quality of life, testosterone, esradiol, leptin, HbA1c, cholesterol, prostate volume [ Time Frame: 18 months ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

blood samples

Estimated Enrollment:	20
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2009

Groups/Cohorts	Assigned Interventions
1	Procedure: Bariatric Surgery one time lapb-band gastric bypass surgery

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.

Eligibility

Ages Eligible for Study:	20 Years to 60 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients asked to enroll will be obese men who are undergoing bariatric surgery, lap-band surgery, at Maimonides Medical Center.

Criteria

Inclusion Criteria:

obese men undergoing lap-band surgey

Exclusion Criteria:

prior diagnosis of prostate cancer, prior prostate surgery, use of 5-alpha reductase inhibitors and history prostatitsis or recurrent UTI.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562341

Locations

United States, New York
Maimonides Medical Center	Recruiting
Brooklyn, New York, United States, 11219
Contact: Jason Wynberg jwynberg@maimonidesmed.org
Principal Investigator: Jason Wynberg, MD
Sub-Investigator: Danny Sherwinter, MD
Sub-Investigator: Richard Savel, MD
Sub-Investigator: Payam Hakimian, MD
Sub-Investigator: Michael l Blute, Jr, MD
Sub-Investigator: James A Kashanian, MD

Sponsors and Collaborators

Maimonides Medical Center

Investigators

Principal Investigator:

Jason Wynberg, MD

MMC

More Information

Study ID Numbers:	07/09/VA18
Study First Received:	November 20, 2007
Last Updated:	November 21, 2007
ClinicalTrials.gov Identifier:	NCT00562341
Health Authority:	United States: Institutional Review Board

Keywords provided by Maimonides Medical Center:

obesity
psa
prostate cancer

Study placed in the following topic categories:

Obesity
Genital Neoplasms, Male
Prostatic Diseases
Overweight
Urogenital Neoplasms
Methyltestosterone
Genital Diseases, Male
Testosterone 17 beta-cypionate

Body Weight
Signs and Symptoms
Testosterone
Weight Loss
Body Weight Changes
Nutrition Disorders
Overnutrition
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009