ObesityNCT00562341
Effect of Lap-Band Induced Weight Loss on Serum PSA Levels
An observational study of Obesity and Prostate Cancer, run by Maimonides Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men only
- Conditions the study is for
- Obesity, Prostate Cancer
- What is being tested?
- Bariatric Surgery
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to 31 Dec 2009
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Men only
- No healthy volunteers
- Adult
Study population: Patients asked to enroll will be obese men who are undergoing bariatric surgery, lap-band surgery, at Maimonides Medical Center.
Who may be able to join
- obese men undergoing lap-band surgery
Who cannot join
- prior diagnosis of prostate cancer
- prior prostate surgery
- use of 5-alpha reductase inhibitors
- history of prostatitis
- recurrent Urinary Tract Infection (UTI).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Lap-Band Induced Weight Loss on Serum PSA Levels, Testosterone, Estrogen and Other Serum Markers
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.
Read the 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.
- Conditions
- Obesity, Prostate Cancer
- Being tested
- Bariatric Surgery
- Keywords
- obesity, psa, prostate cancer
- Medical subject headings
- Obesity, Prostatic Neoplasms, Salivary Gland Adenoma, Pleomorphic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric SurgeryOther
one time lapb-band gastric bypass surgery
| Study group | Role | What they receive |
|---|---|---|
| bariatric surgery | description of enrollees Receives: Other: Bariatric Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (4)
Effect of Lapband-induced weight loss on quality of life
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
Measured: 18 months
Effect of Lapband-induced weight loss on sexual function
Measured using EPIC and Sexual Health Inventory for Men (SHIM)
Measured: 18 months
Effect of Lapband-induced weight loss on prostate size and associated urinary symptoms
Measured using EPIC and the International Prostate Symptom Score (IPSS)
Measured: 18 months
Receiver Operating Curve (ROC) analysis to evaluate PSA cancer detection performance
ROC analysis - prostate cancer vs. no prostate cancer (1-specificity vs. sensitivity for all cutoff values in the range of all PSA levels observed)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2007 (estimated)
- Study startNov 2007
- Primary completion31 Dec 2009
- Study completion31 Dec 2009
Why it stopped: enrollment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Maimonides Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Wynberg, MD, Principal investigator, MMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562341
- Sponsor's protocol ID
- 07/09/VA18
- Status last verified
- Aug 2018
- First submitted
- 20 Nov 2007
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lap-Band Induced Weight Loss on Serum PSA Levels, Testosterone, Estrogen and Other Serum Markers
- ClinicalTrials.gov ID
- NCT00562341
- Acronym / sponsor ID
- 07/09/VA18
- Conditions
- Obesity, Prostate Cancer
- Keywords
- obesity, psa, prostate cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: enrollment challenges
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maimonides Medical CenterUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- 31 Dec 2009 (actual)
- Study completion
- 31 Dec 2009 (actual)
- First posted
- 22 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bariatric surgery | – | Other: Bariatric Surgerydescription of enrollees |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients asked to enroll will be obese men who are undergoing bariatric surgery, lap-band surgery, at Maimonides Medical Center.
Key inclusion criteria (1 listed)
- obese men undergoing lap-band surgery
Key exclusion criteria (5 listed)
- prior diagnosis of prostate cancer
- prior prostate surgery
- use of 5-alpha reductase inhibitors
- history of prostatitis
- recurrent Urinary Tract Infection (UTI).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric Surgeryone time lapb-band gastric bypass surgery | Other | bariatric surgery |
Primary outcome
Prostate-Specific Antigen (PSA) value
Time frame: 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.
4 secondary outcomes
Effect of Lapband-induced weight loss on quality of life
Time frame: 18 months
Effect of Lapband-induced weight loss on sexual function
Time frame: 18 months
Effect of Lapband-induced weight loss on prostate size and associated urinary symptoms
Time frame: 18 months
Receiver Operating Curve (ROC) analysis to evaluate PSA cancer detection performance
Time frame: 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Wynberg, MD principal investigator
MMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Prostate Cancer, run by Maimonides Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate-Specific Antigen (PSA) value (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.