EMPOWER Men to Reduce Weight and Inhibit Prostate Cancer Progression

Study Overview
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Brief Summary
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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
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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.

Official Title
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EMPOWER Men to Reduce Weight and Inhibit Prostate Cancer Progression

Conditions
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Prostatic Neoplasm

Intervention / Treatment
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* Behavioral: EMPOWER


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMPOWER<br>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<br>* Behavioral weight loss intervention<br>|
| No Intervention: Standard of Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of men who experience clinical progression | Proportion of men who experience clinical progression defined as development of (1) pain that, in the medical oncologist's opinion, is secondary to prostate cancer, or (2) a pathologic fracture or other skeletal event. | Up to 24 months | 
| PSA doubling time | PSA doubling time calculated using 3 values (≥1 week apart; Memorial Sloan Kettering Cancer Center prediction tool) | Up to 24 months | 
| Change in PSA | Change in PSA level (ng/mL). | 6 months, 12 months, and 24 months |