Back to resultsEMPOWER Men to Reduce Weight and Inhibit Prostate Cancer Progression
Primary Purpose
Prostatic Neoplasm
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EMPOWER
Sponsored by
About this trial
This is an interventional prevention trial for Prostatic Neoplasm
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)
Sites / Locations
- Johns Hopkins University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
EMPOWER
Standard of Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
PSA doubling time
PSA doubling time calculated using 3 values (≥1 week apart; Memorial Sloan Kettering Cancer Center prediction tool)
Change in PSA
Change in PSA level (ng/mL).
Full Information
NCT ID
NCT04266431
First Posted
February 10, 2020
Last Updated
March 20, 2023
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
American Cancer Society, Inc., Maryland Cigarette Restitution Fund
1. Study Identification
Unique Protocol Identification Number
NCT04266431
Brief Title
EMPOWER Men to Reduce Weight and Inhibit Prostate Cancer Progression
Official Title
EMPOWER Men to Reduce Weight and Inhibit Prostate Cancer Progression
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
American Cancer Society, Inc., Maryland Cigarette Restitution Fund
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasm
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EMPOWER
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
EMPOWER
Intervention Description
Behavioral weight loss intervention
Primary Outcome Measure Information:
Title
Proportion of men who develop prostate specific antigen (PSA) progression or radiographic progression
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Proportion of men who experience clinical progression
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.
Time Frame
Up to 24 months
Title
PSA doubling time
Description
PSA doubling time calculated using 3 values (≥1 week apart; Memorial Sloan Kettering Cancer Center prediction tool)
Time Frame
Up to 24 months
Title
Change in PSA
Description
Change in PSA level (ng/mL).
Time Frame
6 months, 12 months, and 24 months
Other Pre-specified Outcome Measures:
Title
Change in weight
Description
Weight measured by scale in kilograms (kg).
Time Frame
6 months, 12 months, and 24 months
Title
Change in waist circumference
Description
Waist circumference [in centimeters (cm)] using an anthropometric measuring tape at a horizontal plane that is one cm above the navel.
Time Frame
6 months, 12 months, and 24 months
Title
Change in diet
Description
Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)
Time Frame
6 months, 12 months, and 24 months
Title
Change in physical activity
Description
Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire
Time Frame
6 months, 12 months, and 24 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinne Joshu, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for primary and secondary outcome measures will be made available.
IPD Sharing Time Frame
Starting 6 months after publication
IPD Sharing 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.
Learn more about this trial
EMPOWER Men to Reduce Weight and Inhibit Prostate Cancer Progression
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