NCT04266431Completed
EMPOWER Men to Reduce Weight and Inhibit Prostate Cancer Progression
Source: ClinicalTrials.gov · Last updated 12 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 10 Feb 2020
- Start date
- 20 Feb 2020
- Primary completion date
- 31 May 2024
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Diseases
- Prostate cancer
- NCT number
- NCT04266431
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 20 Feb 2020 to the primary completion date, 31 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Unintentional or intentional weight loss within 6 months of enrollment (≥ 5% of body weight)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.