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Trial Title:
Physical Function During ARSI Treatment
NCT ID:
NCT05612880
Condition:
Advanced Prostate Carcinoma
Conditions: Official terms:
Prostatic Neoplasms
Androgens
Conditions: Keywords:
androgen deprivation therapy
ARSI
physical function
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
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
Arm group label:
Non-intervention controls
Other name:
abiraterone
Other name:
enzalutamide
Other name:
darolutamide
Other name:
apalutamide
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Contact:
Last name:
Erik D Hanson, PhD
Phone:
919-962-0816
Email:
edhanson@email.unc.edu
Investigator:
Last name:
Young Whang, MD
Email:
Sub-Investigator
Investigator:
Last name:
Matthew Milowsky, MD
Email:
Sub-Investigator
Investigator:
Last name:
Ethan Basch, MD
Email:
Sub-Investigator
Investigator:
Last name:
Tracy Rose, MD
Email:
Sub-Investigator
Investigator:
Last name:
Brian Miller, MD
Email:
Sub-Investigator
Investigator:
Last name:
Claudio Battaglini, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Eric Ryan, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Dominic Moore, MS
Email:
Sub-Investigator
Start date:
October 13, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05612880
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
