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NCT03867357 · ClinicalTrials.gov registry record

Intramuscular Mechanisms of Androgen Deprivation-related Sarcopenia

A clinical trial, sponsored by Seattle Institute for Biomedical and Clinical Research.

Completed
Registry status
60
Enrollment target

NCT03867357: Completed study, sponsored by Seattle Institute for Biomedical and Clinical Research.

NCT03867357 is a clinical trial that has completed, run by Seattle Institute for Biomedical and Clinical Research. The registered enrollment target is 60 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03867357 has completed, sponsored by Seattle Institute for Biomedical and Clinical Research.

COMPLETED
Registry status
60 participants
Enrollment target

Study Summary

Prostate cancer (PCa) is the most common cancer among men and is even more common in the military and veteran population. For patients with advanced prostate cancer, the most common treatment includes lowering the levels of the hormone testosterone as much as possible. This is called "androgen deprivation therapy" or "ADT". Unfortunately, ADT also causes patients to be fatigued, weak and to loose muscle. This is often referred to as "sarcopenia" and it leads to falls, poor quality of life and higher risk of death. Currently, there is no treatment for sarcopenia because the investigators do not understand the mechanisms that cause it. The mitochondria is the part of the cells responsible for providing energy to muscles but to this date the investigators do not know if it is affected in prostate cancer patients with sarcopenia due to ADT. The overall goal of this proposal is to establish if the mitochondria is responsible for sarcopenia in patients with prostate cancer receiving ADT. The investigators will measure mitochondrial function, muscle mass and strength, and feelings of fatigue and quality of life in patients with prostate cancer before starting and after 6 months of ADT.

Primary Outcome

Changes in LBM (kg) measured by X-ray densitometry (DEXA).

Interventions

  • DRUG GnRH agonist

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2018-12-07
Est. Completion 2023-09-01

What the finished NCT03867357 record still lists

NCT03867357 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target.

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

NCT03867357 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03867357 about?

NCT03867357 is a clinical study titled "Intramuscular Mechanisms of Androgen Deprivation-related Sarcopenia". Prostate cancer (PCa) is the most common cancer among men and is even more common in the military and veteran population. For patients with advanced prostate cancer, the most common treatment includes lowering the levels of the hormone testosterone as much as possible. This is called "androgen depri...

What is the current status of trial NCT03867357?

This trial is currently completed. The enrollment target is 60 participants. The study started on 2018-12-07. Estimated completion is 2023-09-01.

What interventions are being tested in trial NCT03867357?

The interventions under investigation include: GnRH agonist (DRUG).

Who is sponsoring clinical trial NCT03867357?

This trial is sponsored by Seattle Institute for Biomedical and Clinical Research, which has 43 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03867357, the US trial registry maintained by the National Library of Medicine. NCT03867357 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.