Weight Management for Prostate Cancer

(WARRIOR Trial)

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Must not be taking: 5 alpha reductase inhibitors

Disqualifiers: Radiation therapy, Active cancer treatment, Metastasis, Biochemical recurrence, High risk conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jill M. Hamilton-Reeves

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

This trial is for men newly diagnosed with prostate cancer (stages T1 or T2) who are overweight or obese, with a BMI between 25-45 kg/m2. Participants must be scheduled for radical prostatectomy and have internet access to join the study.

Inclusion Criteria

Body Mass Index (BMI) 25-45 kg/m2

Has internet access

I am a man newly diagnosed with prostate cancer and scheduled for complete prostate removal.

Exclusion Criteria

Evidence of biochemical recurrence

I am receiving treatment after my cancer has not responded to initial treatments.

I have not taken any 5 alpha reductase inhibitors in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

4-16 weeks

Weight Maintenance Program

Participants will follow a weight maintenance program for 6 months after their surgery

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Standardized educational flyer
• Weight Loss Program
• Weight Maintenance Program

Trial Overview The study is examining the effects of a weight management program on cancer biomarkers in blood versus just receiving an educational flyer about diet and exercise. It aims to see if managing weight can influence recovery from surgery and cancer outcomes.

Participant Groups

Group I: Weight Loss and Weight Maintenance Experimental Treatment 2 Interventions

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.

Group II: Control Active Control 1 Intervention

Participants will receive a standardized educational flyer about a healthy diet and exercise.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+