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NCT05054296 · ClinicalTrials.gov registry record · Phase 2

Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Risk Factor Modification Program and Continuous Fitbit Monitoring

A Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Stage IV Prostate Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.

Recruiting
Registry status
Phase 2
Development phase
200
Enrollment target
1
Study location

NCT05054296 is a Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Stage IV Prostate Cancer AJCC v8 that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 200 participants, above the 173-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (16% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT05054296, a Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Stage IV Prostate Cancer AJCC v8, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.

RECRUITING
Registry status
Phase 2
Development phase
200 participants
Enrollment target
1
Study location

Study Summary

This phase II trial studies how well an exercise program and continuous Fitbit monitoring work for managing metabolic syndrome and cardiovascular disease risk in patients with prostate cancer that has spread to other places in the body (metastatic) or has come back (recurrent) and does not response to treatment (refractory) and are receiving androgen deprivation therapy. Balancing treatment efficacy, drug side effects, and competing comorbidities with prostate cancer is essential. This trial is being done to learn if an exercise program can help to improve metabolic syndrome and cardiovascular (heart) fitness in prostate cancer patients who are receiving androgen deprivation therapy.

Interventions

  • OTHER Quality-of-Life Assessment
  • OTHER Questionnaire Administration
  • BEHAVIORAL Educational Intervention
  • BEHAVIORAL Exercise Intervention
  • DEVICE FitBit

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2020-03-23
Est. Completion 2027-02-02
Phase Phase 2

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

What the Registry Record Tells You About NCT05054296

The ClinicalTrials.gov registry entry for NCT05054296 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 173-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (16% higher). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Stage IVB Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.

NCT05054296 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT05054296 about?

NCT05054296 is a clinical study titled "Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Risk Factor Modification Program and Continuous Fitbit Monitoring". This phase II trial studies how well an exercise program and continuous Fitbit monitoring work for managing metabolic syndrome and cardiovascular disease risk in patients with prostate cancer that has spread to other places in the body (metastatic) or has come back (recurrent) and does not response ...

What is the current status of trial NCT05054296?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2020-03-23. Estimated completion is 2027-02-02.

What conditions does trial NCT05054296 study?

This clinical trial studies the following conditions: Stage IVB Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Metastatic Prostate Adenocarcinoma, Biochemically Recurrent Prostate Carcinoma.

What interventions are being tested in trial NCT05054296?

The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Educational Intervention (BEHAVIORAL), Exercise Intervention (BEHAVIORAL), FitBit (DEVICE).

Who is sponsoring clinical trial NCT05054296?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05054296 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.