N/A
Completed N=40
Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy
Source: ClinicalTrials.gov NCT03261271 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Impact of Weight Loss Before and Weight Maintenance After Prostate Cancer (PCa) Surgery on Immunosuppressive Factors — 19.29; 17.37; 17.68; 12.76 count of cells — p=0.6489
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Impact of Weight Loss Before and Weight Maintenance After Prostate Cancer (PCa) Surgery on Immunosuppressive Factors |
19.29; 17.37; 17.68; 12.76; 40.52; 32.91 | 0.6489 |
| SECONDARY Impact of Weight Loss Before and Weight Maintenance After PCa Surgery on Inflammation Factors |
0.28; 0.28; 0.16; 0.29; 0.11; 0.25 | 0.0323 sig |
| SECONDARY Change in Weight |
106.9; 101.5; 101.1; 100.6; 95.8; 99.8 | <0.0001 sig |
| SECONDARY Change in Body Composition |
39.2; 37.6; 37.1; 37.4; 34.0; 36.7 | <0.0001 sig |
| SECONDARY Change in Quality of Life |
47.8; 48.0; 52.5; 48.6; 52.0; 47.7 | 0.09 |
Eligibility Criteria
Inclusion Criteria
- Men newly diagnosed with PCa who are scheduled for radical prostatectomy (RP) (T1 or T2)
- Body Mass Index (BMI) 25-45 kg/m2
- Has internet access
Exclusion Criteria
- History of 5 alpha reductase inhibitors prior 3 months
- History of radiation therapy for cancer treatment
- Taking active cancer treatment
- Undergoing salvage therapy
- Castration-resistant PCa
- Evidence of metastasis
- Evidence of biochemical recurrence
- High risk medical condition (e.g. kidney disease, uncontrolled diabetes, etc.)
Data sourced from ClinicalTrials.gov (NCT03261271). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.