Clinical trial · Observational
Effect of Lap-Band Induced Weight Loss on Serum PSA Levels
Effect of Lap-Band Induced Weight Loss on Serum PSA Levels, Testosterone, Estrogen and Other Serum Markers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): enrollment challenges
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Obesity | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bariatric Surgery | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- bariatric surgery
- description
- description of enrollees
- interventionNames
- Other: Bariatric Surgery
Primary outcomes (1)
- measure
- Prostate-Specific Antigen (PSA) value
- timeFrame
- 18 months
- description
- 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 outcomes (4)
- measure
- Effect of Lapband-induced weight loss on quality of life
- timeFrame
- 18 months
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available