Assessing Physical Function Following Androgen Receptor Signaling Inhibitor Treatment for Metastatic Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Physical function: Short physical performance battery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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
研究组 & 干预措施
Non-intervention controls
Men with advanced prostate cancer initiating androgen receptor signaling inhibitor treatment.
干预措施: androgen receptor signaling inhibitors (Drug)
结局指标
主要结局
Physical function: Short physical performance battery
时间窗: 24weeks
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.
Physical function: 400m Walk
时间窗: 24 weeks
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.
Physical function: Timed Up and Go
时间窗: 24 weeks
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.
次要结局
- Body composition: lean mass(24 weeks)
- Body composition: thigh muscle cross-sectional area(24 weeks)
- Muscle Power(24 weeks)
- Fatigue: FACIT-F(24 weeks)
- Depression and Anxiety(24 weeks)
- Bone Pain: FACT-BP(24 weeks)
- Body composition: fat mass(24 weeks)
- Body composition: bone mass(24weeks)
- Body composition: thigh muscle quality(24 weeks)
- Body composition: skeletal muscle(24 weeks)
- Body composition: visceral adipose tissue(24 weeks)
- Grip Strength(24 weeks)
- Body composition: subcutaneous adipose tissue(24 weeks)
- Quality of Life: FACT-P(24 weeks)
- Balance: NeuroCom(24 weeks)
- Arterial Stiffness: SphygmoCor(24 weeks)