What side effects are associated with this type of intervention?

Common treatments for prostate cancer include androgen deprivation therapy (ADT), abiraterone, and lifestyle interventions such as weight loss and exercise. ADT can lead to side effects like bone loss, muscle weakness, fatigue, and cardiovascular issues. Abiraterone may cause hypertension and hypokalemia. Lifestyle interventions, particularly those focused on weight loss and exercise, can help mitigate some of these side effects by improving muscle strength, cardiorespiratory fitness, and overall quality of life.

What prior FDA approvals exist?

FDA-approved treatments for prostate cancer include androgen deprivation therapy (ADT) combined with drugs like abiraterone and enzalutamide, which have shown significant improvements in survival and progression-free survival. Additionally, lutetium Lu 177 vipivotide tetraxetan has been approved for PSMA-positive metastatic castration-resistant prostate cancer. While the EMPOWER trial focuses on a lifestyle intervention for weight loss, there are no specific FDA approvals for such interventions in prostate cancer treatment mentioned in the provided context.

What other types of research exist?

Promising novel alternatives to the EMPOWER lifestyle intervention for prostate cancer patients include: 1) The ENGAGE program, which combines clinician referral with a 12-week exercise training program and discounted gym membership to increase physical activity. 2) The ExerciseGuide, a web- and telephone-based personalized exercise intervention tailored for individuals with metastatic prostate cancer. 3) The EXACT trial, which explores a home-based exercise intervention focusing on moderate aerobic and strengthening exercises to manage side effects in men with metastatic castrate-resistant prostate cancer.

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Behavioral Intervention

EMPOWER Weight-Loss Program for Prostate Cancer

N/A

Waitlist Available

Led By Corinne Joshu, PhD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status < 2

Definitive therapy (surgery or radiation) should be at least 4 weeks from time of consent.

Must not have

Unstable angina or medical conditional that would prevent routine exercise

MI, stroke or ASCVD procedure within 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months, 12 months, and 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a weight loss program called EMPOWER can slow down prostate cancer in men whose cancer has returned after initial treatment. The goal is to delay the spread of cancer and avoid harsh treatments. Weight loss might help slow cancer growth, improving overall health without significant side effects.

Who is the study for?

Men with prostate cancer that's come back after treatment, who are overweight (BMI >= 25), can use the internet regularly, and have a stable health status. They should be willing to change their lifestyle and must not have had any major cardiovascular events recently or be on weight loss drugs or certain other medications.

What is being tested?

The EMPOWER trial is testing if a special program focused on losing weight can slow down prostate cancer progression in men whose cancer has returned. Participants will either join this program or receive standard care, decided randomly.

What are the potential side effects?

Since EMPOWER is a lifestyle intervention focusing on diet and exercise rather than medication, side effects may include typical exercise-related injuries or stress. No drug-related side effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can do all my daily activities without help.

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It has been over 4 weeks since my last surgery or radiation treatment.

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My prostate cancer has returned after treatment, shown by a PSA level of 0.2 ng/mL or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot exercise regularly due to a heart condition or other medical issue.

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I haven't had a heart attack, stroke, or heart disease treatment in the last 6 months.

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I don't have a condition that makes it hard to measure my weight or where losing weight would be harmful.

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I have lost more than 5% of my weight in the last 6 months without trying.

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I haven't used any prescription weight loss drugs or over-the-counter orlistat in the last 6 months.

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I have had or am planning to have weight loss surgery.

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My scans show cancer has spread to other parts of my body.

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I have been on medication for over 6 months that can cause weight gain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months, 12 months, and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months, 12 months, and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months, 12 months, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of men who develop prostate specific antigen (PSA) progression or radiographic progression

Secondary study objectives

Change in PSA

PSA doubling time

Proportion of men who experience clinical progression

Other study objectives

Change in diet

Change in physical activity

Change in waist circumference

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EMPOWERExperimental Treatment1 Intervention

EMPOWER is a multichannel, behavioral lifestyle intervention delivered remotely. The goals of EMPOWER are to induce a loss of 5% or more of initial weight within 6 months and to maintain these improvements at 12 and 24 months, by meeting dietary and physical activity goals. Coach-participant contacts will occur by phone and email, without in-person visits. Coaching contacts will be weekly for the first 12 weeks and then monthly thereafter. Men will have access to a web-based system that (1) provides support for behavioral methods of weight management and (2) allows coaches to review participant self-monitoring data and monitor participant progress towards goals. Men will record diet, exercise, and weight on the web or on a smart phone application.

Group II: Standard of CareActive Control1 Intervention

Men randomized to the standard of care group will continue to receive treatment from the mens' medical oncologist. These men will also be provided with a one page informative brochure on lifestyle recommendations adapted from the American Cancer Society Prostate Cancer Survivorship Care Guidelines, at the time of randomization. At the end of the trial, men in this arm will be offered a one-time counseling session with an intervention coach on healthy lifestyle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EMPOWER

2022

N/A

~100

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for prostate cancer include androgen deprivation therapy (ADT), which works by lowering serum testosterone levels to inhibit cancer growth, and lifestyle interventions focused on weight loss, such as those studied in the EMPOWER trial. ADT is effective in reducing symptoms and delaying disease progression but can have significant side effects like bone loss and cardiovascular issues. Lifestyle interventions, including diet and exercise, aim to improve overall health, reduce obesity-related risks, and potentially slow cancer progression. These interventions are crucial as they not only target cancer directly but also enhance quality of life and mitigate some of the adverse effects associated with traditional treatments.

The Individualized Diet and Exercise Adherence Pilot Trial (IDEA-P) in prostate cancer patients undergoing androgen deprivation therapy: study protocol for a randomized controlled trial.