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Intramuscular Mechanisms of Androgen Deprivation-related Sarcopenia

NCT03867357 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2024-09-04

No results posted yet for this 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.

Conditions

Interventions

DRUG

GnRH agonist

Zoladex is a gonadotropin-releasing hormone agonist, or GnRH-A. It is an implant that is injected under the skin (subcutaneously). The implant gradually dissolves and releases the drug over the time between injections. There are two dosages of Zoladex: Zoladex 10.8 mg, which is injected once every 3 months, and Zoladex 3.6 mg, which is injected once a month.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • University of Washington

    collaborator OTHER

  • Seattle Institute for Biomedical and Clinical Research

    lead OTHER

Principal Investigators

  • Jose M Garcia, MD, PhD · Veterans Affairs Puget Sound Health Care System, University of Washington

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-07
Primary Completion
2023-09-01
Completion
2023-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03867357 on ClinicalTrials.gov