Physical Function During ARSI Treatment

Clinicaltrials.gov ID: NCT05612880
db-list-check Status RECRUITING
b-loader Phase
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 24

Conditions

Advanced Prostate Carcinoma

Drugs

androgen receptor signaling inhibitors

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

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 inhibitors

    Description:

    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

Time Frame: Baseline

Physical function: 400m Walk

Time Frame: 12 weeks

Physical function: 400m Walk

Time Frame: 24 weeks

Physical function: Timed Up and Go

Time Frame: Baseline

Physical function: Timed Up and Go

Time Frame: 12 weeks

Physical function: Timed Up and Go

Time Frame: 24 weeks

Physical function: Short physical performance battery

Time Frame: Baseline

Physical function: Short physical performance battery

Time Frame: 12 weeks

Physical function: Short physical performance battery

Time Frame: 24weeks

Secondary Outcome Measures

Body composition: lean mass

Time Frame: Baseline

Body composition: lean mass

Time Frame: 12 weeks

Body composition: lean mass

Time Frame: 24 weeks

Body composition: fat mass

Time Frame: Baseline

Body composition: fat mass

Time Frame: 12 weeks

Body composition: fat mass

Time Frame: 24 weeks

Body composition: bone mass

Time Frame: Baseline

Body composition: bone mass

Time Frame: 12 weeks

Body composition: bone mass

Time Frame: 24weeks

Body composition: thigh muscle cross-sectional area

Time Frame: Baseline

Body composition: thigh muscle cross-sectional area

Time Frame: 12 weeks

Body composition: thigh muscle cross-sectional area

Time Frame: 24 weeks

Body composition: thigh muscle quality

Time Frame: Baseline

Body composition: thigh muscle quality

Time Frame: 12 weeks

Body composition: thigh muscle quality

Time Frame: 24 weeks

Body composition: skeletal muscle

Time Frame: Baseline

Body composition: skeletal muscle

Time Frame: 12 weeks

Body composition: skeletal muscle

Time Frame: 24 weeks

Body composition: subcutaneous adipose tissue

Time Frame: Baseline

Body composition: subcutaneous adipose tissue

Time Frame: 12 weeks

Body composition: subcutaneous adipose tissue

Time Frame: 24 weeks

Body composition: visceral adipose tissue

Time Frame: Baseline

Body composition: visceral adipose tissue

Time Frame: 12 weeks

Body composition: visceral adipose tissue

Time Frame: 24 weeks

Grip Strength

Time Frame: Baseline

Grip Strength

Time Frame: 12 weeks

Grip Strength

Time Frame: 24 weeks

Muscle Power

Time Frame: Baseline

Muscle Power

Time Frame: 12 weeks

Muscle Power

Time Frame: 24 weeks

Fatigue: FACIT-F

Time Frame: Baseline

Fatigue: FACIT-F

Time Frame: 12 weeks

Fatigue: FACIT-F

Time Frame: 24 weeks

Depression and Anxiety

Time Frame: Baseline

Depression and Anxiety

Time Frame: 12 weeks

Depression and Anxiety

Time Frame: 24 weeks

Bone Pain: FACT-BP

Time Frame: Baseline

Bone Pain: FACT-BP

Time Frame: 12 weeks

Bone Pain: FACT-BP

Time Frame: 24 weeks

Quality of Life: FACT-P

Time Frame: Baseline

Quality of Life: FACT-P

Time Frame: 12 weeks

Quality of Life: FACT-P

Time Frame: 24 weeks

Balance: NeuroCom

Time Frame: Baseline

Balance: NeuroCom

Time Frame: 12 weeks

Balance: NeuroCom

Time Frame: 24 weeks

Arterial Stiffness: SphygmoCor

Time Frame: Baseline

Arterial Stiffness: SphygmoCor

Time Frame: 12 weeks

Arterial Stiffness: SphygmoCor

Time Frame: 24 weeks

Timeline

  • Last Updated
    October 18, 2024
  • Start Date
    November 10, 2022
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    December 31, 2024

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