EMPOWER Men to Reduce Weight and Inhibit Prostate Cancer Progression

Prostatic Neoplasm Clinical Trial

Official title:

EMPOWER Men to Reduce Weight and Inhibit Prostate Cancer Progression

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04266431
• Other study ID #: J1976
• Secondary ID: Rsg-18-147-01-Cc
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 20, 2020
• Est. completion date: May 2025

Study information

• Verified date: March 2024
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: May 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Disease Progression
• Prostatic Neoplasm
• Prostatic Neoplasms

Intervention

Behavioral:
• EMPOWER
Behavioral weight loss intervention

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	American Cancer Society, Inc., Maryland Cigarette Restitution Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in weight	Weight measured by scale in kilograms (kg).	6 months, 12 months, and 24 months
Other	Change in waist circumference	Waist circumference [in centimeters (cm)] using an anthropometric measuring tape at a horizontal plane that is one cm above the navel.	6 months, 12 months, and 24 months
Other	Change in diet	Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)	6 months, 12 months, and 24 months
Other	Change in physical activity	Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire	6 months, 12 months, and 24 months
Primary	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	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
Secondary	PSA doubling time	PSA doubling time calculated using 3 values (=1 week apart; Memorial Sloan Kettering Cancer Center prediction tool)	Up to 24 months
Secondary	Change in PSA	Change in PSA level (ng/mL).	6 months, 12 months, and 24 months