Physical Function During ARSI Treatment

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Advanced Prostate Carcinoma

Treatments: Drug: androgen receptor signaling inhibitors

Study type: Observational

Funder types: Other

Identifiers

NCT05612880

LCCC2214

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

24 participants in 1 patient group

Non-intervention controls

Description:

Men with advanced prostate cancer initiating androgen receptor signaling inhibitor treatment.

Treatment:

Drug: androgen receptor signaling inhibitors