Clinical trial NCT04266431: 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
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasm
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: Maryland Cigarette Restitution Fund
First posted: 2020-02-12
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Proportion of men who develop prostate specific antigen (PSA) progression or radiographic progression
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of men who experience clinical progression
timeFrame: Up to 24 months
measure: PSA doubling time
timeFrame: Up to 24 months
measure: Change in PSA
timeFrame: 6 months, 12 months, and 24 months
Other outcomes:
measure: Change in weight
timeFrame: 6 months, 12 months, and 24 months
measure: Change in waist circumference
timeFrame: 6 months, 12 months, and 24 months
measure: Change in diet
timeFrame: 6 months, 12 months, and 24 months
measure: Change in physical activity
timeFrame: 6 months, 12 months, and 24 months
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Corinne Joshu, PhD
role: PRINCIPAL_INVESTIGATOR
References: