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

Not Applicable

Completed

• Conditions: Prostate Cancer; Obesity
• Interventions: Behavioral: Weight Loss Program; Behavioral: Standardized educational flyer; Behavioral: Weight Maintenance Program

• Registration Number: NCT03261271
• Lead Sponsor: University of Kansas Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-08-22
• Study First Posted: 2017-08-24
• Study Start: 2017-11-02
• Primary Completion: 2023-11-28
• Results First Submitted: 2024-10-29
• Results First Submitted QC: 2025-02-05
• Results First Posted: 2025-02-26
• Study Completion: 2025-03-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weight Loss and Weight Maintenance	Weight Loss Program	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.
Weight Loss and Weight Maintenance	Weight Maintenance Program	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.
Control	Standardized educational flyer	Participants will receive a standardized educational flyer about a healthy diet and exercise.

Primary Outcome Measures

Name	Time	Method
Impact of Weight Loss Before and Weight Maintenance After Prostate Cancer (PCa) Surgery on Immunosuppressive Factors	Change from Baseline to Month 6	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.

Secondary Outcome Measures

Name	Time	Method
Change in Weight	Change from Baseline to Month 6	Body weight will be measured at participant study visits.
Impact of Weight Loss Before and Weight Maintenance After PCa Surgery on Inflammation Factors	Change from Baseline to Month 6	Impact will be measured by changes in specific blood biomarker leptin/adiponectin ratio.
Change in Body Composition	Change from Baseline to Study End	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.
Change in Quality of Life	Change from Baseline to Month 6	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.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States