Physical Function During ARSI Treatment
Conditions
Advanced Prostate CarcinomaDrugs
androgen receptor signaling inhibitorsSummary
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.
Detailed 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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Erik D Hanson, PhD
- 919-962-0816
- [email protected]
Principal Investigator
- Erik D Hanson, PhD
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
Study Plan
Non-intervention controls
Men with advanced prostate cancer initiating androgen receptor signaling inhibitor treatment.
DRUG:
androgen receptor signaling inhibitorsDescription:
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
Outcome Measures
Primary Outcome Measures
Physical function: 400m Walk
Physical function: 400m Walk
Physical function: 400m Walk
Physical function: Timed Up and Go
Physical function: Timed Up and Go
Physical function: Timed Up and Go
Physical function: Short physical performance battery
Physical function: Short physical performance battery
Physical function: Short physical performance battery
Secondary Outcome Measures
Body composition: lean mass
Body composition: lean mass
Body composition: lean mass
Body composition: fat mass
Body composition: fat mass
Body composition: fat mass
Body composition: bone mass
Body composition: bone mass
Body composition: bone mass
Body composition: thigh muscle cross-sectional area
Body composition: thigh muscle cross-sectional area
Body composition: thigh muscle cross-sectional area
Body composition: thigh muscle quality
Body composition: thigh muscle quality
Body composition: thigh muscle quality
Body composition: skeletal muscle
Body composition: skeletal muscle
Body composition: skeletal muscle
Body composition: subcutaneous adipose tissue
Body composition: subcutaneous adipose tissue
Body composition: subcutaneous adipose tissue
Body composition: visceral adipose tissue
Body composition: visceral adipose tissue
Body composition: visceral adipose tissue
Grip Strength
Grip Strength
Grip Strength
Muscle Power
Muscle Power
Muscle Power
Fatigue: FACIT-F
Fatigue: FACIT-F
Fatigue: FACIT-F
Depression and Anxiety
Depression and Anxiety
Depression and Anxiety
Bone Pain: FACT-BP
Bone Pain: FACT-BP
Bone Pain: FACT-BP
Quality of Life: FACT-P
Quality of Life: FACT-P
Quality of Life: FACT-P
Balance: NeuroCom
Balance: NeuroCom
Balance: NeuroCom
Arterial Stiffness: SphygmoCor
Arterial Stiffness: SphygmoCor
Arterial Stiffness: SphygmoCor
Timeline
Last Updated
October 18, 2024Start Date
November 10, 2022Today
January 16, 2025Completion Date ( Estimated )
December 31, 2024
Sponsors of this trial
Lead Sponsor
UNC Lineberger Comprehensive Cancer Center