Physical Function During ARSI Treatment

NCT05612880 | Completed DMC

• 1 other identifier: LCCC2214
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Prostate Carcinoma

Keywords

androgen deprivation therapy; ARSI; physical function

Outcome Measures

Primary Outcomes (9)

• Physical function: 400m Walk

  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.

  Baseline

• Physical function: 400m Walk

  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.

  12 weeks

• Physical function: 400m Walk

  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.

  24 weeks

• Physical function: Timed Up and Go

  The time to complete (in sec) the 2.44m (8 ft) timed up and go test will be performed as an indicator of agility, balance, and physical function. A lower total time is indicative of greater performance.

  Baseline

• Physical function: Timed Up and Go

  The time to complete (in sec) the 2.44m (8 ft) timed up and go test will be performed as an indicator of agility, balance, and physical function. A lower total time is indicative of greater performance.

  12 weeks

• Physical function: Timed Up and Go

  The time to complete (in sec) the 2.44m (8 ft) timed up and go test will be performed as an indicator of agility, balance, and physical function. A lower total time is indicative of greater performance.

  24 weeks

• Physical function: Short physical performance battery

  The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. The scores range from 0 (worst performance) to 12 (best performance). The SPPB has been shown to have predictive validity showing a gradient of risk for mortality, nursing home admission, and disability. Clinically meaningful changes are 0.3-1.0 points.

  Baseline

• Physical function: Short physical performance battery

  The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. The scores range from 0 (worst performance) to 12 (best performance). The SPPB has been shown to have predictive validity showing a gradient of risk for mortality, nursing home admission, and disability. Clinically meaningful changes are 0.3-1.0 points.

  12 weeks

• Physical function: Short physical performance battery

  The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. The scores range from 0 (worst performance) to 12 (best performance). The SPPB has been shown to have predictive validity showing a gradient of risk for mortality, nursing home admission, and disability. Clinically meaningful changes are 0.3-1.0 points.

  24weeks

Secondary Outcomes (48)

• Body composition: lean mass

  Baseline

• Body composition: lean mass

  12 weeks

• Body composition: lean mass

  24 weeks

• Body composition: fat mass

  Baseline

• Body composition: fat mass

  12 weeks

Other Outcomes (6)

• Self-Reported Physical Activity Levels

  Baseline

• Self-Reported Physical Activity Levels

  12 weeks

• Self-Reported Physical Activity Levels

  24 weeks

Study Arms (1)

Non-intervention controls

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

Drug: androgen receptor signaling inhibitors

Interventions

androgen receptor signaling inhibitors DRUG

Prior to or within 8 weeks of ARSI initiation, men with advanced prostate cancer will perform baseline testing, with follow ups at 12 and 24 weeks

Also known as: abiraterone, enzalutamide, darolutamide, apalutamide

Non-intervention controls

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men with metastatic prostate cancer, or recurrent disease following definitive local treatment, on androgen deprivation therapy, who are initiating treatment with androgen receptor signaling inhibitors.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Interventions

abiraterone; enzalutamide; darolutamide; apalutamide

Study Officials

• Erik D Hanson, PhD

  UNC-Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: November 10, 2022
• Study Start: October 13, 2022
• Primary Completion: November 6, 2024
• Study Completion: November 6, 2024
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)