EMPOWER Men to Reduce Weight and Inhibit Prostate Cancer Progression

NCT ID: NCT04266431

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-20
• Study Completion Date: 2025-02-03

Brief Summary

This study will evaluate whether a lifestyle intervention focused on weight loss, EMPOWER, reduces prostate cancer progression at 12 months among men with biochemical recurrence following local treatment for prostate cancer. Half of the men will be randomized to receive the EMPOWER intervention, while the other half will receive standard of care.

Detailed Description

Approximately 500,000 US men are living with biochemical recurrent prostate cancer (BCR). Therapies are needed to delay the appearance of metastatic disease and need for androgen deprivation therapy (ADT), which has significant adverse side effects. Observational evidence suggests that weight loss may slow the rate of disease progression. The EMPOWER trial will use an enhanced version of a remote weight loss intervention shown to yield clinically significant weight loss to test whether weight loss reduces prostate cancer progression at 12 months. EMPOWER has the potential to provide men with BCR a "first line therapy" to slow disease progression and delay the need for ADT. Importantly, this "treatment" is without significant side effects, and can improve overall health.

Conditions

Prostatic Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

EMPOWER

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 Type: EXPERIMENTAL

EMPOWER

Intervention Type: BEHAVIORAL

Behavioral weight loss intervention

Standard of Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

EMPOWER

Behavioral weight loss intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Understand and voluntarily sign consent form
• Able to adhere to study protocol
• Demonstrated use of internet and email
• Access to internet at least 4 days per week
• Willingness to change diet, physical activity and weight
• Willingness to be randomized to immediate start or standard of care
• Histologically confirmed diagnosis of adenocarcinoma of the prostate with evidence of biochemical recurrence following local therapy (surgery and radiation will be allowed). Biochemical recurrence will be defined as a PSA >= 0.2 ng/mL.
• Surgically treated men must not be eligible for or decline salvage radiation. Men who recurred within 3 years of completion of salvage radiation will be included.
• Definitive therapy (surgery or radiation) should be at least 4 weeks from time of consent.
• Men who received prior hormone therapy with definitive local therapy (standard with radiation) are permitted if serum testosterone level is >150 ng/dL and hormone treatment was discontinued > 1 year from time of enrollment.
• Body mass index >= 25 kg/m2
• Eastern Cooperative Oncology Group (ECOG) performance status < 2
• Willingness to return for clinical visit at 6 months, 12 months, and 24 months
• Men receiving testosterone replacement therapy will be included if they are on a stable dose with testosterone levels in the normal range.

Exclusion Criteria

• Any clinical or radiographic evidence of metastatic disease by computed tomography (CT) of the chest, abdomen and pelvis and technetium-99 bone scintigraphy (bone scan)
• MI, stroke or ASCVD procedure within 6 months
• Serious medical condition likely to hinder accurate measurement of weight, or for which weight loss is contraindicated, or which would cause weight loss
• Unstable angina or medical conditional that would prevent routine exercise
• Prior or planned bariatric surgery
• Use of prescription weight loss medication (including off label use of medications) or over-the-counter orlistat within 6 months
• Chronic use (at least past 6 months) of medications likely to cause weight gain or prevent weight loss (e.g. corticosteroids, lithium, olanzapine, risperidone, clozapine), including androgen deprivation therapy
• Unintentional or intentional weight loss within 6 months of enrollment (≥ 5% of body weight)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

Maryland Cigarette Restitution Fund

OTHER_GOV

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Corinne Joshu, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

Rsg-18-147-01-Cce

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00221103

Identifier Type: OTHER

Identifier Source: secondary_id

J1976

Identifier Type: -

Identifier Source: org_study_id