NCT05612880Completed
Physical Function During ARSI Treatment
Assessing Physical Function Following Androgen Receptor Signaling Inhibitor Treatment for Metastatic Prostate Cancer
Source: ClinicalTrials.gov · Last updated 9 Jan 2025
Brief summary (registry, in English)
This single arm observational pilot study aims to determine the longitudinal effects of androgen receptor signaling inhibitors (ARSI) in men with advanced prostate cancer. The primary outcome for this trial is physical function, which will be evaluated at baseline, 12 and 24 weeks. Secondary outcomes including body composition, muscle function, balance, arterial stiffness and patient reported outcomes.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 24 (actual)
- First submitted
- 19 Oct 2022
- Start date
- 13 Oct 2022
- Primary completion date
- 6 Nov 2024
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- Prostate cancer
- NCT number
- NCT05612880
What you commit to
- Study type: Observational
- Participants enrolled: 24
- From 13 Oct 2022 to the primary completion date, 6 Nov 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 ARSI treatment
- Current chemotherapy
- Intention to leave the region prior to completion of study
Other illness
- History of bone fractures or musculoskeletal injuries
- Neurological conditions that affect balance and/or muscle strength
- Dementia, altered mental status or any psychiatric condition prohibiting the understanding or rendering of informed consent
Who the study is looking for
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Subjects is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
- Age ≥ 18 years at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Diagnosis of metastatic disease from prostate cancer, or recurrent disease following definitive local therapy of prostate cancer, as assessed by their clinician
- Initiation of an ARSI (e.g., abiraterone, enzalutamide, apalutamide, or darolutamide) for mPC with concurrent androgen deprivation therapy (ADT).
- Availability to begin baseline testing within 8 weeks of ARSI treatment initiation.
- Physician clearance to perform physical assessments.
- Ability to speak and read English.
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 |
|---|---|---|---|
| Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.