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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 belowSelect...
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 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
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 moreTrial 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
557 Previous Clinical Trials
32,880 Total Patients Enrolled
57 Trials studying Prostate Cancer
3,348 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot exercise regularly due to a heart condition or other medical issue.I haven't had a heart attack, stroke, or heart disease treatment in the last 6 months.I am a man who either can't have or chose not to have further radiation after surgery, or I had a recurrence within 3 years after salvage radiation.I can do all my daily activities without help.You are open to making changes in your diet, physical activity, and weight.I don't have a condition that makes it hard to measure my weight or where losing weight would be harmful.It has been over 4 weeks since my last surgery or radiation treatment.I have lost more than 5% of my weight in the last 6 months without trying.I haven't used any prescription weight loss drugs or over-the-counter orlistat in the last 6 months.I have had or am planning to have weight loss surgery.I am a man who stopped hormone therapy over a year ago and my testosterone is above 150 ng/dL.I am willing to attend follow-up visits at 6, 12, and 24 months.You have a high body mass index (BMI), which means you may be overweight.My scans show cancer has spread to other parts of my body.My prostate cancer has returned after treatment, shown by a PSA level of 0.2 ng/mL or higher.I am on a stable dose of testosterone replacement with normal levels.I am open to starting treatment immediately or following standard care.I have been on medication for over 6 months that can cause weight gain.
Research Study Groups:
This trial has the following groups:- Group 1: EMPOWER
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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