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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
20
Behavioral weight loss intervention
Johns Hopkins University
Baltimore, Maryland, United States
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.
Time frame: 12 months
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.
Time frame: Up to 24 months
PSA doubling time
PSA doubling time calculated using 3 values (≥1 week apart; Memorial Sloan Kettering Cancer Center prediction tool)
Time frame: Up to 24 months
Change in PSA
Change in PSA level (ng/mL).
Time frame: 6 months, 12 months, and 24 months
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