An interventional study of Weight Loss Program and Standardized educational flyer in Obesity and Prostate Cancer, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-04-13.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Basic science
The purpose of this study is to test how a weight management program affects substances in the blood called biomarkers that can show the presence or severity of cancer, compared to a standardized diet and exercise educational flyer.
Exclusion Criteria:
Participants will take part in a weight loss program for at least 4 weeks (and up to 16 weeks) before their prostatectomy, and a weight maintenance program for 6 months after their surgery.
Behavioral: Weight Loss Program · Behavioral: Weight Maintenance Program
Participants will receive a standardized educational flyer about a healthy diet and exercise.
Behavioral: Standardized educational flyer
Program involves one-on-one coaching, diet meal plan, and physical activity plan.
The American Institute for Cancer Research handout "Nutrition and the Cancer Survivor" will be provided to participants.
Post-surgery program involves group support sessions, phone check-ins, and diet and exercise monitoring.
Impact of Weight Loss Before and Weight Maintenance After Prostate Cancer (PCa) Surgery on Immunosuppressive Factors
Impact will be measured by changes in specific blood immune biomarker monocytic myeloid-derived suppressor cells (mMDSCs). The absolute number of cell counts were calculated using the lymphocyte count abstracted from the complete blood count with differential.
Time frame: Change from Baseline to Month 6
Impact of Weight Loss Before and Weight Maintenance After PCa Surgery on Inflammation Factors
Impact will be measured by changes in specific blood biomarker leptin/adiponectin ratio.
Time frame: Change from Baseline to Month 6
Change in Weight
Body weight will be measured at participant study visits.
Time frame: Change from Baseline to Month 6
Change in Body Composition
Body composition will be measured using a Dual Energy X-Ray Absorptiometry (iDXA). Change in percent body fat will be analyzed between groups from baseline to study end.
Time frame: Change from Baseline to Study End
Change in Quality of Life
Quality of Life will be measured using the Expanded PCa Index Composite (EPIC) Instrument-26. There are a total of 26 items on the survey. Scores range from 0 to 100. The higher the score, the higher the quality of life.
Time frame: Change from Baseline to Month 6
Participant enrollment took place from November 2017 to August 2020 at The University of Kansas Health System. Participants were recruited from the Department of Urology medical clinic.
| Milestone | Weight Loss and Weight Maintenance | Control |
|---|---|---|
| Started | 20 | 20 |
| Completed | 19 | 19 |
| Not completed | 1 | 1 |
| Withdrew: Treatment changed after surgery. participants were removed from the study. | 1 | 1 |
Impact will be measured by changes in specific blood immune biomarker monocytic myeloid-derived suppressor cells (mMDSCs). The absolute number of cell counts were calculated using the lymphocyte count abstracted from the complete blood count with differential.
| count of cells | Weight Loss and Weight Maintenance | Control |
|---|---|---|
| Baseline mMDSC count | 19.29 ± 26.72 | 17.37 ± 18.96 |
| 1 week prior to surgery mMDSC count | 17.68 ± 21.14 | 12.76 ± 15.64 |
| 6 months after surgery mMDSC count | 40.52 ± 44.87 | 32.91 ± 36.38 |
Impact will be measured by changes in specific blood biomarker leptin/adiponectin ratio.
| leptin/adiponectin ratio | Weight Loss and Weight Maintenance | Control |
|---|---|---|
| Baseline leptin/adiponectin ratio | 0.28 ± 0.29 | 0.28 ± 0.27 |
| 1 week prior to surgery leptin/adiponectin ratio | 0.16 ± 0.21 | 0.29 ± 0.22 |
| 6 months after surgery leptin/adiponectin ratio | 0.11 ± 0.14 | 0.25 ± 0.32 |
Body weight will be measured at participant study visits.
| weight in kilograms | Weight Loss and Weight Maintenance | Control |
|---|---|---|
| Baseline body weight (kg) | 106.9 ± 17.2 | 101.5 ± 10.4 |
| 1 week prior to surgery body weight (kg) | 101.1 ± 16.5 | 100.6 ± 11.1 |
| 6 months after surgery body weight (kg) | 95.8 ± 17.5 | 99.8 ± 11.1 |
Body composition will be measured using a Dual Energy X-Ray Absorptiometry (iDXA). Change in percent body fat will be analyzed between groups from baseline to study end.
| percentage of body fat | Weight Loss and Weight Maintenance | Control |
|---|---|---|
| Baseline body fat % | 39.2 ± 4.9 | 37.6 ± 4.3 |
| 1 week prior to surgery body fat % | 37.1 ± 5.4 | 37.4 ± 4.8 |
| 6 months after surgery body fat % | 34.0 ± 7.6 | 36.7 ± 4.2 |
Quality of Life will be measured using the Expanded PCa Index Composite (EPIC) Instrument-26. There are a total of 26 items on the survey. Scores range from 0 to 100. The higher the score, the higher the quality of life.
| units on a scale | Weight Loss and Weight Maintenance | Control |
|---|---|---|
| General Health Quality of Life at Baseline | 47.8 ± 7.0 | 48.0 ± 7.8 |
| General Health Quality of Life at Pre-Surgery | 52.5 ± 6.0 | 48.6 ± 8.5 |
| General Health Quality of Life at Study End | 52.0 ± 8.6 | 47.7 ± 8.9 |
Collected over 4-16 weeks prior to surgery and 6 months after surgery. At most, 10 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Weight Loss and Weight Maintenance | 0/20 (0%) | 0/20 (0%) | 7/20 (35%) |
| Event | Weight Loss and Weight Maintenance |
|---|---|
| Muscle pain or strainMusculoskeletal and connective tissue disorders | 4/20 |
| ConstipationGastrointestinal disorders | 2/20 |
| BloatingGastrointestinal disorders | 1/20 |
| DizzinessNervous system disorders | 1/20 |
| Age, Continuous(years) | Weight Loss and Weight Maintenance | Control | Total |
|---|---|---|---|
| Mean | 59.25 ± 5.86 | 60.80 ± 5.66 | 60.03 ± 5.74 |
| Sex: Female, Male(Participants) | Weight Loss and Weight Maintenance | Control | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 20 | 20 | 40 |
| Ethnicity (NIH/OMB)(Participants) | Weight Loss and Weight Maintenance | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 20 | 19 | 39 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Weight Loss and Weight Maintenance | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 18 | 18 | 36 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Weight Loss and Weight Maintenance | Control | Total |
|---|---|---|---|
| United States | 20 | 20 | 40 |
| Highest Education Level(Participants) | Weight Loss and Weight Maintenance | Control | Total |
|---|---|---|---|
| High School/GED | 2 | 3 | 5 |
| Some College/Associate's | 10 | 7 | 17 |
| Bachelor's | 4 | 7 | 11 |
| Master's | 4 | 2 | 6 |
| Doctoral | 0 | 0 | 0 |
| Not reported | 0 | 1 | 1 |
| Rural-Urban Commuting Area (RUCA) Codes(Participants) | Weight Loss and Weight Maintenance | Control | Total |
|---|---|---|---|
| RUCA Code 1 | 12 | 13 | 25 |
| RUCA Code 2 | 7 | 2 | 9 |
| RUCA Code 4 | 0 | 1 | 1 |
| RUCA Code 7 | 1 | 2 | 3 |
| RUCA Code 10 | 0 | 2 | 2 |
| Smoking Status(Participants) | Weight Loss and Weight Maintenance | Control | Total |
|---|---|---|---|
| Current Smoker | 2 | 1 | 3 |
| Former Smoker | 8 | 10 | 18 |
| Never Smoked | 10 | 9 | 19 |
6 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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University of Kansas Medical Center