Clinical trial NCT05612880: Physical Function During ARSI Treatment
Official title: Assessing Physical Function Following Androgen Receptor Signaling Inhibitor Treatment for Metastatic Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Prostate Carcinoma
Keywords: androgen deprivation therapy
ARSI
physical function
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

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

Primary outcomes:
measure: Physical function: 400m Walk
timeFrame: Baseline
measure: Physical function: 400m Walk
timeFrame: 12 weeks
measure: Physical function: 400m Walk
timeFrame: 24 weeks
measure: Physical function: Timed Up and Go
timeFrame: Baseline
measure: Physical function: Timed Up and Go
timeFrame: 12 weeks
measure: Physical function: Timed Up and Go
timeFrame: 24 weeks
measure: Physical function: Short physical performance battery
timeFrame: Baseline
measure: Physical function: Short physical performance battery
timeFrame: 12 weeks
measure: Physical function: Short physical performance battery
timeFrame: 24weeks
Secondary outcomes:
measure: Body composition: lean mass
timeFrame: Baseline
measure: Body composition: lean mass
timeFrame: 12 weeks
measure: Body composition: lean mass
timeFrame: 24 weeks
measure: Body composition: fat mass
timeFrame: Baseline
measure: Body composition: fat mass
timeFrame: 12 weeks
measure: Body composition: fat mass
timeFrame: 24 weeks
measure: Body composition: bone mass
timeFrame: Baseline
measure: Body composition: bone mass
timeFrame: 12 weeks
measure: Body composition: bone mass
timeFrame: 24weeks
measure: Body composition: thigh muscle cross-sectional area
timeFrame: Baseline
measure: Body composition: thigh muscle cross-sectional area
timeFrame: 12 weeks
measure: Body composition: thigh muscle cross-sectional area
timeFrame: 24 weeks
measure: Body composition: thigh muscle quality
timeFrame: Baseline
measure: Body composition: thigh muscle quality
timeFrame: 12 weeks
measure: Body composition: thigh muscle quality
timeFrame: 24 weeks
measure: Body composition: skeletal muscle
timeFrame: Baseline
measure: Body composition: skeletal muscle
timeFrame: 12 weeks
measure: Body composition: skeletal muscle
timeFrame: 24 weeks
measure: Body composition: subcutaneous adipose tissue
timeFrame: Baseline
measure: Body composition: subcutaneous adipose tissue
timeFrame: 12 weeks
measure: Body composition: subcutaneous adipose tissue
timeFrame: 24 weeks
measure: Body composition: visceral adipose tissue
timeFrame: Baseline
measure: Body composition: visceral adipose tissue
timeFrame: 12 weeks
measure: Body composition: visceral adipose tissue
timeFrame: 24 weeks
measure: Grip Strength
timeFrame: Baseline
measure: Grip Strength
timeFrame: 12 weeks
measure: Grip Strength
timeFrame: 24 weeks
measure: Muscle Power
timeFrame: Baseline
measure: Muscle Power
timeFrame: 12 weeks
measure: Muscle Power
timeFrame: 24 weeks
measure: Fatigue: FACIT-F
timeFrame: Baseline
measure: Fatigue: FACIT-F
timeFrame: 12 weeks
measure: Fatigue: FACIT-F
timeFrame: 24 weeks
measure: Depression and Anxiety
timeFrame: Baseline
measure: Depression and Anxiety
timeFrame: 12 weeks
measure: Depression and Anxiety
timeFrame: 24 weeks
measure: Bone Pain: FACT-BP
timeFrame: Baseline
measure: Bone Pain: FACT-BP
timeFrame: 12 weeks
measure: Bone Pain: FACT-BP
timeFrame: 24 weeks
measure: Quality of Life: FACT-P
timeFrame: Baseline
measure: Quality of Life: FACT-P
timeFrame: 12 weeks
measure: Quality of Life: FACT-P
timeFrame: 24 weeks
measure: Balance: NeuroCom
timeFrame: Baseline
measure: Balance: NeuroCom
timeFrame: 12 weeks
measure: Balance: NeuroCom
timeFrame: 24 weeks
measure: Arterial Stiffness: SphygmoCor
timeFrame: Baseline
measure: Arterial Stiffness: SphygmoCor
timeFrame: 12 weeks
measure: Arterial Stiffness: SphygmoCor
timeFrame: 24 weeks
Other outcomes:
measure: Self-Reported Physical Activity Levels
timeFrame: Baseline
measure: Self-Reported Physical Activity Levels
timeFrame: 12 weeks
measure: Self-Reported Physical Activity Levels
timeFrame: 24 weeks
measure: Physical Activity: accelerometry
timeFrame: Baseline
measure: Physical Activity: accelerometry
timeFrame: 12 weeks
measure: Physical Activity: accelerometry
timeFrame: 24 weeks
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC-Chapel Hill
name: Erik D Hanson, PhD
role: PRINCIPAL_INVESTIGATOR
References: