Clinical trial · Observational
Physical Function During ARSI Treatment
Assessing Physical Function Following Androgen Receptor Signaling Inhibitor Treatment for Metastatic Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| androgen receptor signaling inhibitors | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Non-intervention controls
- description
- Men with advanced prostate cancer initiating androgen receptor signaling inhibitor treatment.
- interventionNames
- Drug: androgen receptor signaling inhibitors
Primary outcomes (9)
- measure
- Physical function: 400m Walk
- timeFrame
- Baseline
- description
- The time to walk 400m (in sec) will be performed as an indicator of walking endurance. A lower total time (and therefore higher gait speed) indicates greater cardiorespiratory capacity.
- measure
- Physical function: 400m Walk
- timeFrame
- 12 weeks
- description
- The time to walk 400m (in sec) will be performed as an indicator of walking endurance. A lower total time (and therefore higher gait speed) indicates greater cardiorespiratory capacity.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available