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

April 4, 2025 updated by: University of Kansas Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Weight Loss and Weight Maintenance
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
Program involves one-on-one coaching, diet meal plan, and physical activity plan.
Behavioral: Weight Maintenance Program
Post-surgery program involves group support sessions, phone check-ins, and diet and exercise monitoring.
Active Comparator: Control
Participants will receive a standardized educational flyer about a healthy diet and exercise.
Behavioral: Standardized educational flyer
The American Institute for Cancer Research handout "Nutrition and the Cancer Survivor" will be provided to participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Weight Loss Before and Weight Maintenance After Prostate Cancer (PCa) Surgery on Immunosuppressive Factors
Time Frame: 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.
Change from Baseline to Month 6

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

American Cancer Society, Inc.

Investigators

  • Principal Investigator: Jill Hamilton-Reeves, PhD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2017

Primary Completion (Actual)

November 28, 2023

Study Completion (Actual)

March 25, 2025

Study Registration Dates

First Submitted

August 22, 2017

First Submitted That Met QC Criteria

August 22, 2017

First Posted (Actual)

August 24, 2017

Study Record Updates

Last Update Posted (Actual)

April 13, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00141060
  • RSG-17-050-01-NEC (Other Grant/Funding Number: American Cancer Society)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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