EMPOWER Men to Reduce Weight and Inhibit Prostate Cancer Progression

NCT04266431 | Completed

• 3 other identifiers: J1976Rsg-18-147-01-CceIRB00221103
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasm

Outcome Measures

Primary Outcomes (1)

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

  Proportion of men who develop prostate specific antigen (PSA) progression or radiographic progression (e.g. soft tissue or bone lesions). In accordance with the Prostate Cancer Clinical Trials Working Group (PCWG2) criteria, PSA progression will be defined as an increase that is ≥25% and ≥2 ng/mL above the nadir that is confirmed by a second value in ≥3 weeks, soft tissue lesions will be defined using RECIST 1.1 criteria, and bone lesions will be defined as ≥2 new lesions, with a confirmatory scan ≥6 weeks later.

  12 months

Secondary Outcomes (3)

• Proportion of men who experience clinical progression

  Up to 24 months

• PSA doubling time

  Up to 24 months

• Change in PSA

  6 months, 12 months, and 24 months

Other Outcomes (4)

• Change in weight

  6 months, 12 months, and 24 months

• Change in waist circumference

  6 months, 12 months, and 24 months

• Change in diet

  6 months, 12 months, and 24 months

Study Arms (2)

EMPOWER

EXPERIMENTAL

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.

Behavioral: EMPOWER

Standard of Care

NO 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.

Interventions

EMPOWER BEHAVIORAL

Behavioral weight loss intervention

EMPOWER

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• American Cancer Society, Inc.: collaborator
• Maryland Cigarette Restitution Fund: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Corinne Joshu, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The randomization scheme will be generated by the senior biostatistician, and access will be restricted for the duration of the trial. The participants and interventionists will not be blinded to study arm. The study staff involved in data collection, staff involved in laboratory measurements, and the biostatistician conducting the data analysis will be blinded to the random assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible consented men will be stratified for randomization according to prostate specific antigen doubling time (PSADT; \<6 months or 6-12 months) calculated using 3 values (≥1 week apart; ≤ 3 months from randomization; Memorial Sloan Kettering Cancer Center prediction tool: http://nomograms.mskcc.org/Prostate/PsaDoublingTime.aspx), and body mass index (BMI) at baseline (25 kg/m2 ≤BMI \<30 kg/m2 or BMI≥ 30 kg/m2). Following stratification, men will be randomized 1:1 using a computer-generated, password protected randomization enrollment system by the biostatistician. Men will be informed of the random assignment after consenting to the study and completing the baseline questionnaires and blood collection. Study visits will take place at 6 months, 12 months, and 24 months after baseline.

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: February 20, 2020
• Primary Completion: May 31, 2024
• Study Completion: February 3, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 6 months after publication
• Access Criteria: Investigators interested in using study data to address questions beyond the scope of the project can request de-identified data from the PI in writing. The PI will provide access to de-identified data if the study goals are consistent with participant consent, and the requesting investigative team can provide the necessary assurances of proper handling of the data, including Institutional Review Board (IRB) approval and execution of a data use agreement.

Locations

US (1)