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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a weight management program might influence blood markers that indicate prostate cancer. Participants will either join a weight loss and maintenance program or receive a flyer with diet and exercise tips. The trial targets men newly diagnosed with early-stage prostate cancer who plan to have their prostate removed, have a Body Mass Index (BMI) between 25-45, and can regularly access the internet.

As an unphased trial, this study provides a unique opportunity to contribute to understanding the impact of lifestyle changes on prostate cancer markers.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking active cancer treatment or have a high-risk medical condition, you may not be eligible to participate.

What prior data suggests that this weight management program is safe for prostate cancer patients?

Research has shown that weight management programs are generally safe for people with prostate cancer. In past studies, participants in these programs lost a significant amount of weight without major problems. One study reported an average weight loss of about 5.55 kg, including 3.88 kg of fat, in a short time, suggesting the programs are both safe and effective.

Another study found positive results with a home-based weight loss program. Participants lost weight and improved their health compared to those who only received standard care. No major side effects were reported, indicating the program's safety.

Overall, these findings suggest that weight loss and maintenance programs are safe and could be a helpful part of managing prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Weight Loss and Weight Maintenance program for prostate cancer patients because it introduces a lifestyle-focused approach rather than relying solely on medical or surgical treatments. Unlike traditional treatments such as surgery, radiation, or hormone therapy, this program emphasizes significant weight loss before surgery, followed by structured weight maintenance afterward. This dual-phase approach could potentially enhance recovery and overall outcomes by promoting a healthier body environment, which is a unique angle compared to existing options.

What evidence suggests that this trial's weight management programs could be effective for prostate cancer?

Research shows that managing weight can benefit men with prostate cancer. In this trial, participants in the Weight Loss and Weight Maintenance arm will engage in a weight loss program before their prostatectomy and a weight maintenance program after surgery. One study found that men in a weight management program lost about 5.5% of their starting weight before prostate surgery and 11% by the end of the study. Another study found that weight loss was more effective than standard care in slowing cancer progression. Many men with prostate cancer also aim to lose weight or eat healthier. These findings suggest that managing weight might improve health outcomes for those with prostate cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Jill M. Hamilton-Reeves

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12001425/

Weight Management Experiences Among People Affected by ... 3456 participants living with or beyond breast, prostate or colorectal cancer and affected by overweight and obesity completed our questionnaire ...

2. auajournals.org auajournals.org/doi/10.1097/JU.0000000000003849

Impact of Weight Management on Obesity-Driven ... In this intervention, participants lost 5.5% of their initial body weight by the time of RP and a net loss of 11% by study end. The 5.5% ...

3. mdpi.com mdpi.com/1718-7729/31/3/127

PC-PEP, a Comprehensive Daily Six-Month Home-Based ... PC-PEP led to significant weight loss in men undergoing curative prostate cancer treatment compared to standard-of-care.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05764330

Weight Loss Interventions to Reduce Cancer Progression ... This clinical trial examines weight loss interventions in reducing cancer progression in prostate cancer patients under active surveillance.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4991822/

Weight Management to Reduce Prostate Cancer Risk Most men reported their diet needed minor improvement (74%), and 65% of men reported they are either currently trying to lose weight or interested in weight ...

6. fredhutch.org fredhutch.org/en/news/spotlight/2024/04/phs-wright-cancer.html

Transforming prostate cancer management through the ... The study's outcomes were promising. Participants in the intervention group not only achieved significant weight loss but also showed notable ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33295204/

Feasibility of a Weight Management Program Tailored for ... Results: The intervention led to 5.55 kg of weight loss including 3.88 kg of fat loss from baseline to surgery (mean = 8.3 weeks). The ...