EMPOWER Men to Reduce Weight and Inhibit Prostate Cancer Progression

  • STATUS
    Recruiting
  • participants needed
    130
  • sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Updated on 19 February 2024
cancer
body mass index
ct scan
metastasis
hormone therapy
adenocarcinoma
endocrine therapy
testosterone
bone scan
definitive treatment
local therapy
tumor progression
testosterone level
serum testosterone
adenocarcinoma of prostate
definitive therapy
prostate cancer

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.

Details
Condition Malignant neoplasm of prostate, Prostatic disorder
Age 18years - 100years
Treatment EMPOWER
Clinical Study IdentifierNCT04266431
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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)
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