N/A N=40 Randomized Basic Science

Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy

Obesity · Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT03261271 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2025

Primary outcome: 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 count of cells — p=0.6489

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Weight Loss Program (Behavioral); Standardized educational flyer (Behavioral); Weight Maintenance Program (Behavioral)
Age: Adult, Older Adult · 50+ yrs
Sex: Male
Sponsor: University of Kansas Medical Center
Primary completion: Nov 2023

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

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.

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.)

View full record on ClinicalTrials.gov →

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.