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NCT04266431 · ClinicalTrials.gov registry record · NA

EMPOWER Men to Reduce Weight and Inhibit Prostate Cancer Progression

A NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Completed
Registry status
NA
Development phase
20
Enrollment target

NCT04266431: Completed NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

NCT04266431 is a NA study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04266431, a NA study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target

Study 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.

Primary Outcome

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 sc

Interventions

  • BEHAVIORAL EMPOWER

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2020-02-20
Est. Completion 2025-02-03
Phase NA

What the finished NCT04266431 record still lists

NCT04266431 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which EMPOWER is the first listed.

NCT04266431 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04266431 about?

NCT04266431 is a clinical study titled "EMPOWER Men to Reduce Weight and Inhibit Prostate Cancer Progression". 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, whi...

What is the current status of trial NCT04266431?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2020-02-20. Estimated completion is 2025-02-03.

What interventions are being tested in trial NCT04266431?

The interventions under investigation include: EMPOWER (BEHAVIORAL).

Who is sponsoring clinical trial NCT04266431?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04266431's enrollment target sits among peer trials

20 1768th of 2000 higher than 140 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04266431, the US trial registry maintained by the National Library of Medicine. NCT04266431 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.