Advanced Prostate CarcinomaNCT05612880
Physical Function During ARSI Treatment
An observational study of Advanced Prostate Carcinoma, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Advanced Prostate Carcinoma
- What is being tested?
- androgen receptor signaling inhibitors
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2022to 6 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Show all 9Show fewer
- Availability to begin baseline testing within 8 weeks of ARSI treatment initiation.
- Physician clearance to perform physical assessments.
- Ability to speak and read English.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Assessing Physical Function Following Androgen Receptor Signaling Inhibitor Treatment for Metastatic Prostate Cancer
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.
Read the 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.
- Conditions
- Advanced Prostate Carcinoma
- Being tested
- androgen receptor signaling inhibitors
- Keywords
- androgen deprivation therapy, ARSI, physical function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
androgen receptor signaling inhibitorsDrug
Also called abiraterone, enzalutamide, darolutamide, apalutamide
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
| Study group | Role | What they receive |
|---|---|---|
| Non-intervention controls | Men with advanced prostate cancer initiating androgen receptor signaling inhibitor treatment. Receives: Drug: androgen receptor signaling inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24weeks
Secondary outcomes (48)
Body composition: lean mass
To report total body lean mass using dual-energy x-ray absorptiometry (DXA).
Measured: Baseline
Body composition: lean mass
To report total body lean mass using dual-energy x-ray absorptiometry (DXA).
Measured: 12 weeks
Body composition: lean mass
To report total body lean mass using dual-energy x-ray absorptiometry (DXA).
Measured: 24 weeks
Body composition: fat mass
To report total body fat mass using dual-energy x-ray absorptiometry (DXA).
Measured: Baseline
Body composition: fat mass
To report total body fat mass using dual-energy x-ray absorptiometry (DXA).
Measured: 12 weeks
Body composition: fat mass
To report total body fat mass using dual-energy x-ray absorptiometry (DXA).
Measured: 24 weeks
Body composition: bone mass
To report total body bone mass using dual-energy x-ray absorptiometry (DXA).
Measured: Baseline
Body composition: bone mass
To report total body bone mass using dual-energy x-ray absorptiometry (DXA).
Measured: 12 weeks
Body composition: bone mass
To report total body bone mass using dual-energy x-ray absorptiometry (DXA).
Measured: 24weeks
Body composition: thigh muscle cross-sectional area
Muscle size will be analyzed using ultrasound of the vastus lateralis of the dominant leg. Higher muscle mass and quality are associated with greater muscle strength, physical function, QoL, and mortality.
Measured: Baseline
Body composition: thigh muscle cross-sectional area
Muscle size will be analyzed using ultrasound of the vastus lateralis of the dominant leg. Higher muscle mass and quality are associated with greater muscle strength, physical function, QoL, and mortality.
Measured: 12 weeks
Body composition: thigh muscle cross-sectional area
Muscle size will be analyzed using ultrasound of the vastus lateralis of the dominant leg. Higher muscle mass and quality are associated with greater muscle strength, physical function, QoL, and mortality.
Measured: 24 weeks
Body composition: thigh muscle quality
Muscle architecture will be analyzed using ultrasound of the vastus lateralis of the dominant leg. Higher muscle mass and quality are associated with greater muscle strength, physical function, QoL, and mortality. Muscle quality is reported in arbitrary units, where a lower value indicates a higher/better muscle quality.
Measured: Baseline
Body composition: thigh muscle quality
Muscle architecture will be analyzed using ultrasound of the vastus lateralis of the dominant leg. Higher muscle mass and quality are associated with greater muscle strength, physical function, QoL, and mortality. Muscle quality is reported in arbitrary units, where a lower value indicates a higher/better muscle quality.
Measured: 12 weeks
Body composition: thigh muscle quality
Muscle architecture will be analyzed using ultrasound of the vastus lateralis of the dominant leg. Higher muscle mass and quality are associated with greater muscle strength, physical function, QoL, and mortality. Muscle quality is reported in arbitrary units, where a lower value indicates a higher/better muscle quality.
Measured: 24 weeks
Body composition: skeletal muscle
CT scans will also be performed to assess skeletal muscle (SM). The L3 scan is uploaded into a software called SliceOmatic (TomoVision, Montreal, Quebec, Canada) to segment L3 into cross-sectional SM area, SAT area, and VAT area based on Hounsfield Units (HU) ranges: -29 to 150 for SM. An add-on module called Automated Body composition Analyzer using Computed tomography image Segmentation (ABACS) automatically performs the segmentation and produces an unbiased estimation.
Measured: Baseline
Body composition: skeletal muscle
CT scans will also be performed to assess skeletal muscle (SM). The L3 scan is uploaded into a software called SliceOmatic (TomoVision, Montreal, Quebec, Canada) to segment L3 into cross-sectional SM area, SAT area, and VAT area based on Hounsfield Units (HU) ranges: -29 to 150 for SM. An add-on module called Automated Body composition Analyzer using Computed tomography image Segmentation (ABACS) automatically performs the segmentation and produces an unbiased estimation.
Measured: 12 weeks
Body composition: skeletal muscle
CT scans will also be performed to assess skeletal muscle (SM). The L3 scan is uploaded into a software called SliceOmatic (TomoVision, Montreal, Quebec, Canada) to segment L3 into cross-sectional SM area, SAT area, and VAT area based on Hounsfield Units (HU) ranges: -29 to 150 for SM. An add-on module called Automated Body composition Analyzer using Computed tomography image Segmentation (ABACS) automatically performs the segmentation and produces an unbiased estimation.
Measured: 24 weeks
Body composition: subcutaneous adipose tissue
CT scans will also be performed to subcutaneous adipose tissue (SAT). The L3 scan is uploaded into a software called SliceOmatic (TomoVision, Montreal, Quebec, Canada) to segment L3 into cross-sectional SM area, SAT area, and VAT area based on Hounsfield Units (HU) ranges: -190 to -30 for SAT. An add-on module called Automated Body composition Analyzer using Computed tomography image Segmentation (ABACS) automatically performs the segmentation and produces an unbiased estimation.
Measured: Baseline
Body composition: subcutaneous adipose tissue
CT scans will also be performed to subcutaneous adipose tissue (SAT). The L3 scan is uploaded into a software called SliceOmatic (TomoVision, Montreal, Quebec, Canada) to segment L3 into cross-sectional SM area, SAT area, and VAT area based on Hounsfield Units (HU) ranges: -190 to -30 for SAT. An add-on module called Automated Body composition Analyzer using Computed tomography image Segmentation (ABACS) automatically performs the segmentation and produces an unbiased estimation.
Measured: 12 weeks
Body composition: subcutaneous adipose tissue
CT scans will also be performed to subcutaneous adipose tissue (SAT). The L3 scan is uploaded into a software called SliceOmatic (TomoVision, Montreal, Quebec, Canada) to segment L3 into cross-sectional SM area, SAT area, and VAT area based on Hounsfield Units (HU) ranges: -190 to -30 for SAT. An add-on module called Automated Body composition Analyzer using Computed tomography image Segmentation (ABACS) automatically performs the segmentation and produces an unbiased estimation.
Measured: 24 weeks
Body composition: visceral adipose tissue
CT scans will also be performed to assess visceral adipose tissue (VAT). The L3 scan is uploaded into a software called SliceOmatic (TomoVision, Montreal, Quebec, Canada) to segment L3 into cross-sectional SM area, SAT area, and VAT area based on Hounsfield Units (HU) ranges: -150 to -50 for VAT. An add-on module called Automated Body composition Analyzer using Computed tomography image Segmentation (ABACS) automatically performs the segmentation and produces an unbiased estimation.
Measured: Baseline
Body composition: visceral adipose tissue
CT scans will also be performed to assess visceral adipose tissue (VAT). The L3 scan is uploaded into a software called SliceOmatic (TomoVision, Montreal, Quebec, Canada) to segment L3 into cross-sectional SM area, SAT area, and VAT area based on Hounsfield Units (HU) ranges: -150 to -50 for VAT. An add-on module called Automated Body composition Analyzer using Computed tomography image Segmentation (ABACS) automatically performs the segmentation and produces an unbiased estimation.
Measured: 12 weeks
Body composition: visceral adipose tissue
CT scans will also be performed to assess visceral adipose tissue (VAT). The L3 scan is uploaded into a software called SliceOmatic (TomoVision, Montreal, Quebec, Canada) to segment L3 into cross-sectional SM area, SAT area, and VAT area based on Hounsfield Units (HU) ranges: -150 to -50 for VAT. An add-on module called Automated Body composition Analyzer using Computed tomography image Segmentation (ABACS) automatically performs the segmentation and produces an unbiased estimation.
Measured: 24 weeks
Grip Strength
Grip strength will be assessed using a handgrip dynamometer. Grip strength is based on the maximal voluntary contraction of the subject's upper body muscles. One practice repetition is performed on each side. Three trials are performed on each side, alternating sides after every repetition. The maximal grip score from all six trials is recorded.
Measured: Baseline
Grip Strength
Grip strength will be assessed using a handgrip dynamometer. Grip strength is based on the maximal voluntary contraction of the subject's upper body muscles. One practice repetition is performed on each side. Three trials are performed on each side, alternating sides after every repetition. The maximal grip score from all six trials is recorded.
Measured: 12 weeks
Grip Strength
Grip strength will be assessed using a handgrip dynamometer. Grip strength is based on the maximal voluntary contraction of the subject's upper body muscles. One practice repetition is performed on each side. Three trials are performed on each side, alternating sides after every repetition. The maximal grip score from all six trials is recorded.
Measured: 24 weeks
Muscle Power
Muscular power will be assessed using a linear position transducer (LPT). A sit-to-stand (STS) power test will be performed. Two practice repetitions are performed. Subsequently, three trial repetitions are performed, each with 60 seconds of rest in between. The greatest peak and mean power output in watts (W) of the three trial repetitions are used for analysis.
Measured: Baseline
Muscle Power
Muscular power will be assessed using a linear position transducer (LPT). A sit-to-stand (STS) power test will be performed. Two practice repetitions are performed. Subsequently, three trial repetitions are performed, each with 60 seconds of rest in between. The greatest peak and mean power output in watts (W) of the three trial repetitions are used for analysis.
Measured: 12 weeks
Muscle Power
Muscular power will be assessed using a linear position transducer (LPT). A sit-to-stand (STS) power test will be performed. Two practice repetitions are performed. Subsequently, three trial repetitions are performed, each with 60 seconds of rest in between. The greatest peak and mean power output in watts (W) of the three trial repetitions are used for analysis.
Measured: 24 weeks
Fatigue: FACIT-F
Fatigue will be measured using the Functional Assessment of Chronic Illness Therapy Fatigue, a 1-page form that uses a rating scale that goes from 0 (no fatigue) to 10 (severe fatigue). It assesses the patient's fatigue levels in the last 7 days. It also measures how usual activities, performing work, walking, relationship, and enjoyment of life are affected by fatigue. A higher score indicates higher levels of perceived fatigue. Clinically meaningful changes are 3 points.
Measured: Baseline
Fatigue: FACIT-F
Fatigue will be measured using the Functional Assessment of Chronic Illness Therapy Fatigue, a 1-page form that uses a rating scale that goes from 0 (no fatigue) to 10 (severe fatigue). It assesses the patient's fatigue levels in the last 7 days. It also measures how usual activities, performing work, walking, relationship, and enjoyment of life are affected by fatigue. A higher score indicates higher levels of perceived fatigue. Clinically meaningful changes are 3 points.
Measured: 12 weeks
Fatigue: FACIT-F
Fatigue will be measured using the Functional Assessment of Chronic Illness Therapy Fatigue, a 1-page form that uses a rating scale that goes from 0 (no fatigue) to 10 (severe fatigue). It assesses the patient's fatigue levels in the last 7 days. It also measures how usual activities, performing work, walking, relationship, and enjoyment of life are affected by fatigue. A higher score indicates higher levels of perceived fatigue. Clinically meaningful changes are 3 points.
Measured: 24 weeks
Depression and Anxiety
Depression will be measured using the Hospital Anxiety and Depression Scale (HADS), a concise, self-administered 1 page form that categorizes anxiety and depression. The total score goes from 0-21, and scores are categorized from minimal to severe depression/anxiety, with higher total scores indicate worse outcomes.
Measured: Baseline
Depression and Anxiety
Depression will be measured using the Hospital Anxiety and Depression Scale (HADS), a concise, self-administered 1 page form that categorizes anxiety and depression. The total score goes from 0-21, and scores are categorized from minimal to severe depression/anxiety, with higher total scores indicate worse outcomes.
Measured: 12 weeks
Depression and Anxiety
Depression will be measured using the Hospital Anxiety and Depression Scale (HADS), a concise, self-administered 1 page form that categorizes anxiety and depression. The total score goes from 0-21, and scores are categorized from minimal to severe depression/anxiety, with higher total scores indicate worse outcomes.
Measured: 24 weeks
Bone Pain: FACT-BP
Bone pain will be determined using the FACT-BP questionnaire. FACT-BP is a 15-item scale assessing cancer-related bone pain and its effects on quality of life (QoL); the higher the aggregate score, the less the bone pain and/or the better the QoL. All scales score from 0-4 and a high scale score represents a higher response level. Minimal important differences for FACT-BP range from 3-7 points.
Measured: Baseline
Bone Pain: FACT-BP
Bone pain will be determined using the FACT-BP questionnaire. FACT-BP is a 15-item scale assessing cancer-related bone pain and its effects on quality of life (QoL); the higher the aggregate score, the less the bone pain and/or the better the QoL. All scales score from 0-4 and a high scale score represents a higher response level. Minimal important differences for FACT-BP range from 3-7 points.
Measured: 12 weeks
Bone Pain: FACT-BP
Bone pain will be determined using the FACT-BP questionnaire. FACT-BP is a 15-item scale assessing cancer-related bone pain and its effects on quality of life (QoL); the higher the aggregate score, the less the bone pain and/or the better the QoL. All scales score from 0-4 and a high scale score represents a higher response level. Minimal important differences for FACT-BP range from 3-7 points.
Measured: 24 weeks
Quality of Life: FACT-P
Quality of life (QoL) will be measured using the Functional Assessment of Cancer Therapy-Prostate (FACT-P). The FACT-P is composed of both multi-item scales and single-item measures. These include physical, social, emotional, and functional well-being, along with an assessment of prostate-specific health status. five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All scales score from 0-4 and a higher score represents higher QoL. Clinically meaningful changes are 6-10 points.
Measured: Baseline
Quality of Life: FACT-P
Quality of life (QoL) will be measured using the Functional Assessment of Cancer Therapy-Prostate (FACT-P). The FACT-P is composed of both multi-item scales and single-item measures. These include physical, social, emotional, and functional well-being, along with an assessment of prostate-specific health status. five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All scales score from 0-4 and a higher score represents higher QoL. Clinically meaningful changes are 6-10 points.
Measured: 12 weeks
Quality of Life: FACT-P
Quality of life (QoL) will be measured using the Functional Assessment of Cancer Therapy-Prostate (FACT-P). The FACT-P is composed of both multi-item scales and single-item measures. These include physical, social, emotional, and functional well-being, along with an assessment of prostate-specific health status. five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All scales score from 0-4 and a higher score represents higher QoL. Clinically meaningful changes are 6-10 points.
Measured: 24 weeks
Balance: NeuroCom
Balance will be assessed using the NeuroCom Smart Balance Master. A sensory organization test will be performed. An overall composite equilibrium score describing a person's overall level of performance during all of the trials in the sensory organization test is calculated, with a value between 0 and 100, with 0 indicating a large sway and loss of balance, and 100 indicating greater postural control. The composite score is a weighted-average of the following 14 scores: the condition 1 average score, the condition 2 average score, and the three equilibrium scores from each of the trials in conditions 3-6.
Measured: Baseline
Balance: NeuroCom
Balance will be assessed using the NeuroCom Smart Balance Master. A sensory organization test will be performed. An overall composite equilibrium score describing a person's overall level of performance during all of the trials in the sensory organization test is calculated, with a value between 0 and 100, with 0 indicating a large sway and loss of balance, and 100 indicating greater postural control. The composite score is a weighted-average of the following 14 scores: the condition 1 average score, the condition 2 average score, and the three equilibrium scores from each of the trials in conditions 3-6.
Measured: 12 weeks
Balance: NeuroCom
Balance will be assessed using the NeuroCom Smart Balance Master. A sensory organization test will be performed. An overall composite equilibrium score describing a person's overall level of performance during all of the trials in the sensory organization test is calculated, with a value between 0 and 100, with 0 indicating a large sway and loss of balance, and 100 indicating greater postural control. The composite score is a weighted-average of the following 14 scores: the condition 1 average score, the condition 2 average score, and the three equilibrium scores from each of the trials in conditions 3-6.
Measured: 24 weeks
Arterial Stiffness: SphygmoCor
Arterial stiffness will be measured using the SphygmoCor Xcel (AtCor Medical). Arterial stiffness will be assessed using brachial pulse wave analysis (PWA) augmentation index and carotid-femoral pulse wave analysis (PWV). Greater PWA augmentation index and carotid-femoral PWV time indicates greater arterial stiffness, a surrogate end-point for cardiovascular disease.
Measured: Baseline
Arterial Stiffness: SphygmoCor
Arterial stiffness will be measured using the SphygmoCor Xcel (AtCor Medical). Arterial stiffness will be assessed using brachial pulse wave analysis (PWA) augmentation index and carotid-femoral pulse wave analysis (PWV). Greater PWA augmentation index and carotid-femoral PWV time indicates greater arterial stiffness, a surrogate end-point for cardiovascular disease.
Measured: 12 weeks
Arterial Stiffness: SphygmoCor
Arterial stiffness will be measured using the SphygmoCor Xcel (AtCor Medical). Arterial stiffness will be assessed using brachial pulse wave analysis (PWA) augmentation index and carotid-femoral pulse wave analysis (PWV). Greater PWA augmentation index and carotid-femoral PWV time indicates greater arterial stiffness, a surrogate end-point for cardiovascular disease.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start13 Oct 2022
- Primary completion6 Nov 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Prostate CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erik D Hanson, PhD, Principal investigator, UNC-Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612880
- Sponsor's protocol ID
- LCCC2214
- Status last verified
- Jan 2025
- First submitted
- 19 Oct 2022
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The University of North Carolina will be adding and storing data on a secure, centralized server. No individual data will be made available to protect the identity of the patients in the trial.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Physical Function Following Androgen Receptor Signaling Inhibitor Treatment for Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT05612880
- Acronym / sponsor ID
- LCCC2214
- Conditions
- Advanced Prostate Carcinoma
- Keywords
- androgen deprivation therapy, ARSI, physical function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-intervention controls | – | Drug: androgen receptor signaling inhibitorsMen with advanced prostate cancer initiating androgen receptor signaling inhibitor treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| androgen receptor signaling inhibitorsAlso: abiraterone, enzalutamide, darolutamide, apalutamidePrior 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 | Drug | Non-intervention controls |
Primary outcome
Physical function: 400m Walk
Time frame: Baseline
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: 400m Walk
Time frame: 12 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: 400m Walk
Time frame: 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
Time frame: Baseline
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.
Physical function: Timed Up and Go
Time frame: 12 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.
Physical function: Timed Up and Go
Time frame: 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.
Physical function: Short physical performance battery
Time frame: Baseline
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: Short physical performance battery
Time frame: 12 weeks
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: Short physical performance battery
Time frame: 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.
48 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. The University of North Carolina will be adding and storing data on a secure, centralized server. No individual data will be made available to protect the identity of the patients in the trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik D Hanson, PhD principal investigator
UNC-Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Prostate Carcinoma, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical function: 400m Walk (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.