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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, 12 months, and 24 months
Awards & highlights

Study Summary

This trial will compare whether a weight-loss intervention can help prevent prostate cancer progression, compared to standard care.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of men who develop prostate specific antigen (PSA) progression or radiographic progression
Secondary outcome measures
Change in PSA
PSA doubling time
Proportion of men who experience clinical progression
Other outcome measures
Change in diet
Change in physical activity
Change in waist circumference
+1 more

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
~130

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
561 Previous Clinical Trials
33,079 Total Patients Enrolled
58 Trials studying Prostate Cancer
3,428 Patients Enrolled for Prostate Cancer
American Cancer Society, Inc.OTHER
224 Previous Clinical Trials
110,435 Total Patients Enrolled
12 Trials studying Prostate Cancer
1,880 Patients Enrolled for Prostate Cancer
Maryland Cigarette Restitution FundOTHER_GOV
5 Previous Clinical Trials
577 Total Patients Enrolled
2 Trials studying Prostate Cancer
461 Patients Enrolled for Prostate Cancer

Media Library

EMPOWER (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04266431 — N/A
Prostate Cancer Research Study Groups: EMPOWER, Standard of Care
Prostate Cancer Clinical Trial 2023: EMPOWER Highlights & Side Effects. Trial Name: NCT04266431 — N/A
EMPOWER (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04266431 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are admitted into this research experiment?

"Affirmative. According to clinicaltrials.gov, this medical investigation is open for recruitment. The experiment was announced on February 20th 2020 and the latest update occurred on March 18th 2022; 130 participants must be sourced from one location in total."

Answered by AI

Is this research project open to new enrollees?

"This trial, which was initially published on February 20th 2020 and recently revised March 18th 2022, is currently seeking participants. Data hosted by clinicaltrials.gov confirms this fact."

Answered by AI
~4 spots leftby May 2025