Study Stopped
enrollment challenges
Effect of Lap-Band Induced Weight Loss on Serum PSA Levels
1 other identifier
observational
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2007
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 20, 2007
CompletedFirst Posted
Study publicly available on registry
November 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2009
CompletedAugust 23, 2018
August 1, 2018
2.2 years
November 20, 2007
August 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Effect of Lapband-induced weight loss on quality of life
18 months
Effect of Lapband-induced weight loss on sexual function
18 months
Effect of Lapband-induced weight loss on prostate size and associated urinary symptoms
18 months
Receiver Operating Curve (ROC) analysis to evaluate PSA cancer detection performance
18 months
Study Arms (1)
bariatric surgery
description of enrollees
Interventions
Eligibility Criteria
Patients asked to enroll will be obese men who are undergoing bariatric surgery, lap-band surgery, at Maimonides Medical Center.
You may qualify if:
- obese men undergoing lap-band surgery
You may not qualify if:
- prior diagnosis of prostate cancer
- prior prostate surgery
- use of 5-alpha reductase inhibitors
- history of prostatitis
- recurrent Urinary Tract Infection (UTI).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maimonides Medical Center
Brooklyn, New York, 11219, United States
Biospecimen
blood samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Wynberg, MD
MMC
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 18 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2007
First Posted
November 22, 2007
Study Start
November 1, 2007
Primary Completion
December 31, 2009
Study Completion
December 31, 2009
Last Updated
August 23, 2018
Record last verified: 2018-08