Trials / Completed
CompletedNCT04266431
EMPOWER Men to Reduce Weight and Inhibit Prostate Cancer Progression
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | EMPOWER | Behavioral weight loss intervention |
Timeline
- Start date
- 2020-02-20
- Primary completion
- 2024-05-31
- Completion
- 2025-02-03
- First posted
- 2020-02-12
- Last updated
- 2025-02-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04266431. Inclusion in this directory is not an endorsement.