EMPOWER Men to Reduce Weight and Inhibit Prostate Cancer Progression

STATUS

Recruiting
participants needed

130
sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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Updated on 19 February 2024

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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	18-100 years
Treatment	EMPOWER
Clinical Study Identifier	NCT04266431
Sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on	19 February 2024

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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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EMPOWER Men to Reduce Weight and Inhibit Prostate Cancer Progression