Prostate Cancer Clinical Trial
Physical Function During ARSI Treatment
Summary
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.
Full Description
The purpose of this pilot trial is to obtain objective measurements of physical function in men with metastatic prostate cancer (mPC) initiating ARSI treatment at baseline, 12, and 24 weeks later. Grip strength, muscular power, body composition, balance, arterial stiffness, along with QoL, fatigue, anxiety, and depression will also be measured. Finally, the potential associations in primary and secondary outcomes by the type of ARSI, stage of mPC, and physical activity levels will be explored.
With more men requiring ARSI treatment for metastatic castrate resistant prostate cancer (mCRPC), as well as being an efficacious option earlier in metastatic castrate sensitive prostate cancer (mCSPC), accurate estimates of declines from ARSI initiation are required to determine the true effects. Utilizing novel assessments in mPC like muscular power tests will provide insight into potentially more relevant assessments and outcomes to intervene on. The data from this pilot study will also determine effect sizes to adequately power future studies.
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Prior ARSI treatment
Current chemotherapy
History of bone fractures or musculoskeletal injuries
Neurological conditions that affect balance and/or muscle strength
Intention to leave the region prior to completion of study
Dementia, altered mental status or any psychiatric condition prohibiting the understanding or rendering of informed consent
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There is 1 Location for this study
Chapel Hill North Carolina, 27599, United States More Info
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