18 and older, male only, with Castration-resistant Prostate Cancer or Androgen Deprivation Therapy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Patients Who Complete the Pre/Post Exercise Intervention Testing.Primary· 12 weeks after baseline testing
To estimate the feasibility of a 12 week, home-based exercise intervention in metastatic castrate resistant prostate cancer (mCPRC) patients undergoing androgen deprivation therapy by reporting the percentage of patients who complete the pre/post testing following the intervention.
This was calculated as the number of subjects who completed the trial compared to the total number who completed baseline testing.
Group
Value
95% CI
Home-based Exercise
16
Adherence to the InterventionSecondary· 12 weeks after baseline testing
To report the level of adherence to the exercise intervention in patients completing pre/post testing. Successful adherence to the program is completion of 75% of all prescribed exercise and will be assessed using wearable technology to track walking and exercise logs to track resistance training adherence.
Adherence was determined as the number of exercise sessions attempted/completed over the total number of session prescribed.
Overall
Group
Value
95% CI
Home-based Exercise
80.1
Walking
Group
Value
95% CI
Home-based Exercise
65.5
Resistance Training
Group
Value
95% CI
Home-based Exercise
72.8
Physical Function: 6m WalkSecondary· 12 weeks after baseline testing
The time to complete (in sec) the 6m rapid walk test will be performed.
Baseline
Group
Value
95% CI
Home-based Exercise
4.4
± 1.5
Post Intervention
Group
Value
95% CI
Home-based Exercise
4.5
± 1.5
Physical Function: Timed Up and GoSecondary· 12 weeks after baseline testing
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.
Baseline
Group
Value
95% CI
Home-based Exercise
10.4
± 9.1
Post Intervention
Group
Value
95% CI
Home-based Exercise
10.8
± 11.0
Physical Function: Stair ClimbSecondary· 12 weeks after baseline testing
The time to climb a flight of stairs (in sec) will be performed as an indicator of functional strength, muscle power, and balance. A lower total time (and higher calculated power output) is indicative of greater performance.
Baseline
Group
Value
95% CI
Home-based Exercise
6.4
± 2.8
Post Intervention
Group
Value
95% CI
Home-based Exercise
6.2
± 3.2
Physical Function: 400m WalkSecondary· 12 weeks after baseline testing
The time to walk 400m (in sec) will be performed as an indicator of walking endurance and gait speed will be determined. A lower total time and higher gait speed indicates greater cardiorespiratory capacity and will be correlated with cardiopulmonary function scores (outcome 14).
Baseline
Group
Value
95% CI
Home-based Exercise
329.8
± 97.8
Post Intervention
Group
Value
95% CI
Home-based Exercise
313.5
± 87.3
Patient Reported Outcomes: FatigueSecondary· 12 weeks after baseline testing
Fatigue will be measure using the Functional Assessment of Chronic Illness Therapy Fatigue, a 1 page form that uses a rating scale that goes from 0 to 52. 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 quality of life (and lower fatigue).
Baseline
Group
Value
95% CI
Home-based Exercise
39
± 10
Post Intervention
Group
Value
95% CI
Home-based Exercise
40
± 11
Patient Reported Outcomes: Quality of LifeSecondary· 12 weeks after baseline testing
Quality of life 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 of the individual questions are scored from 0-4 with total scores ranging between 0 and 156 where a higher number represents higher QoL.
Baseline
Group
Value
95% CI
Home-based Exercise
119
± 20
Post Intervention
Group
Value
95% CI
Home-based Exercise
119
± 16
Patient Reported Outcomes: DepressionSecondary· 12 weeks after baseline testing
Depression will be measured using the Hospital Anxiety and Depression Scale, 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. Higher total scores indicate greater levels of depression.
Baseline
Group
Value
95% CI
Home-based Exercise
3
± 2
Post Intervention
Group
Value
95% CI
Home-based Exercise
3
± 3
Patient Reported Outcomes: AnxietySecondary· 12 weeks after baseline testing
Depression will be measured using the Hospital Anxiety and Depression Scale, 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. Higher total scores indicate greater levels of depression.
Baseline
Group
Value
95% CI
Home-based Exercise
4
± 3
Post Intervention
Group
Value
95% CI
Home-based Exercise
3
± 2
Muscle Size (Cross-sectional Area)Secondary· 12 weeks after baseline testing
Muscle size will be analyzed using ultrasound of the vastus lateralis of the dominant leg. All assessments will be completed before and after the intervention to determine the muscle size. Higher muscle mass and quality are associated with greater muscle strength, physical function, QoL, and mortality.
Baseline
Group
Value
95% CI
Home-based Exercise
8.3
± 2.9
Post Intervention
Group
Value
95% CI
Home-based Exercise
10.2
± 4.0
Muscle QualitySecondary· 12 weeks after baseline testing
Muscle architecture will be analyzed using ultrasound of the vastus lateralis of the dominant leg. All assessments will be completed before and after the intervention to determine the muscle quality. 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.
Baseline
Group
Value
95% CI
Home-based Exercise
110.2
± 22
Post Intervention
Group
Value
95% CI
Home-based Exercise
114.3
± 16.6
Adverse events — posted to ClinicalTrials.gov
Time frame: 12 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This single arm, multi-site pilot study aims to evaluate the feasibility of recruiting and adherence to a 12 week home-based exercise intervention to be conducted in men with metastatic castration resistant prostate cancer (mCRPC) receiving androgen deprivation therapy (ADT). Thirty patients will be enrolled, with the expectation that 20-25 will complete all follow-up measures.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center
Last refreshed: 20 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03672396.