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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2007 by Maimonides Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00562341
First Posted: November 22, 2007
Last Update Posted: November 22, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Maimonides Medical Center
  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

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

Resource links provided by NLM:


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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00562341     History of Changes
Other Study ID Numbers: 07/09/VA18
First Submitted: November 20, 2007
First Posted: November 22, 2007
Last Update Posted: November 22, 2007
Last Verified: September 2007

Keywords provided by Maimonides Medical Center:
obesity
psa
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Weight Loss
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Body Weight Changes
Body Weight
Signs and Symptoms