Clinical Trials /

EMPOWER Men to Reduce Weight and Inhibit Prostate Cancer Progression

NCT04266431

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: J1976
  • SECONDARY ID: Rsg-18-147-01-Cce
  • SECONDARY ID: IRB00221103
  • NCT ID: NCT04266431

Conditions

  • Prostatic Neoplasm

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
EMPOWERExperimentalEMPOWER 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.
    Standard of CareNo InterventionMen 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.

      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 within 3 years of local therapy (surgery and radiation will be
                   allowed). Biochemical recurrence will be defined as a PSA > 1 ng/mL on at least two
                   occasions, separated by at least 1 month.
      
                -  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 and not more than 3 years.
      
                -  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.
      
                -  No clinical or radiographic evidence of metastatic disease by computed tomography (CT)
                   of the chest, abdomen and pelvis and technetium-99 bone scintigraphy (bone scan)
                   within 3 months.
      
                -  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
      
              Exclusion Criteria:
      
                -  Any evidence of nodal or metastatic disease.
      
                -  Time to biochemical recurrence >3 years after definitive local therapy
      
                -  PSA doubling time >12 months
      
                -  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
      
                -  Use of testosterone replacement therapy 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)
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:Male
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Proportion of men who develop prostate specific antigen (PSA) progression or radiographic progression
      Time Frame:12 months
      Safety Issue:
      Description: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.

      Secondary Outcome Measures

      Measure:Proportion of men who experience clinical progression
      Time Frame:Up to 24 months
      Safety Issue:
      Description: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.
      Measure:PSA doubling time
      Time Frame:Up to 24 months
      Safety Issue:
      Description:PSA doubling time calculated using 3 values (≥1 week apart; Memorial Sloan Kettering Cancer Center prediction tool)
      Measure:Change in PSA
      Time Frame:6 months, 12 months, and 24 months
      Safety Issue:
      Description:Change in PSA level (ng/mL).

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

      Last Updated

      February 21, 2020