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EMPOWER Men to Reduce Weight and Inhibit Prostate Cancer Progression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04266431
Recruitment Status : Recruiting
First Posted : February 12, 2020
Last Update Posted : February 25, 2020
Sponsor:
Collaborators:
American Cancer Society, Inc.
Maryland Cigarette Restitution Fund
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasm Behavioral: EMPOWER Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: EMPOWER Men to Reduce Weight and Inhibit Prostate Cancer Progression
Actual Study Start Date : February 20, 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: EMPOWER
Behavioral weight loss intervention

No 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.



Primary Outcome Measures :
  1. Proportion of men who develop prostate specific antigen (PSA) progression or radiographic progression [ Time Frame: 12 months ]
    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 :
  1. Proportion of men who experience clinical progression [ Time Frame: Up to 24 months ]
    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.

  2. PSA doubling time [ Time Frame: Up to 24 months ]
    PSA doubling time calculated using 3 values (≥1 week apart; Memorial Sloan Kettering Cancer Center prediction tool)

  3. Change in PSA [ Time Frame: 6 months, 12 months, and 24 months ]
    Change in PSA level (ng/mL).


Other Outcome Measures:
  1. Change in weight [ Time Frame: 6 months, 12 months, and 24 months ]
    Weight measured by scale in kilograms (kg).

  2. Change in waist circumference [ Time Frame: 6 months, 12 months, and 24 months ]
    Waist circumference [in centimeters (cm)] using an anthropometric measuring tape at a horizontal plane that is one cm above the navel.

  3. Change in diet [ Time Frame: 6 months, 12 months, and 24 months ]
    Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)

  4. Change in physical activity [ Time Frame: 6 months, 12 months, and 24 months ]
    Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04266431


Contacts
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Contact: Corinne Joshu, PhD (443) 287-3821 cjosuh1@jhu.edu

Locations
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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Colburn Yu    443-287-6419    EMPOWERtrial@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
American Cancer Society, Inc.
Maryland Cigarette Restitution Fund
Investigators
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Principal Investigator: Corinne Joshu, PhD Johns Hopkins Bloomberg School of Public Health
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT04266431    
Other Study ID Numbers: J1976
Rsg-18-147-01-Cce ( Other Grant/Funding Number: American Cancer Society )
IRB00221103 ( Other Identifier: Johns Hopkins School of Medicine IRB )
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases