Prostate Cancer Clinical Trial

EMPOWER Men to Reduce Weight and Inhibit Prostate Cancer Progression

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.

View Full Description

Full 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.

View Eligibility Criteria

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)

Study is for people with:

Prostate Cancer

Estimated Enrollment:

20

Study ID:

NCT04266431

Recruitment Status:

Active, not recruiting

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Johns Hopkins University
Baltimore Maryland, 21287, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

20

Study ID:

NCT04266431

Recruitment Status:

Active, not recruiting

Sponsor:


Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.