Design of debunking the frailty-sarcopenia-ADT axis in metastatic prostate cancer with multicomponent exercise: the FIERCE trial protocol.
Rebekah L Wilson, Anderson Vulczak, Alicia K Morgans...
https://pubmed.ncbi.nlm.nih.gov/41210271Actively Recruiting
Phase Not Applicable
Age: 18Years +
MALE
ID06040125
Debunking the Frailty-Sarcopenia-ADT Axis in Metastatic Prostate Cancer With Multicomponent Exercise: The FIERCE Trial
Led by Dana-Farber Cancer Institute · Updated on 2026-03-11
80
Participants Needed
3
Research Sites
26 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
P
Prostate Cancer Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether a 16-week supervised exercise program combining resistance and aerobic exercises can improve frailty, muscle loss (sarcopenia), and disease outcomes in men with metastatic prostate cancer who are receiving androgen deprivation therapy. This pilot randomized controlled study is the first to test this intervention in this patient group. The study is funded by the Prostate Cancer Foundation and led by Dana-Farber Cancer Institute. Participants are randomly assigned to either a supervised circuit training group or an attention control group. The exercise group will complete a 16-week multicomponent program with sessions supervised by a certified exercise oncology trainer and home-based aerobic exercises. They will use a stationary bike and wear an activity and heart rate monitor. The control group will continue their normal daily activities without additional exercise intervention. During the study, participants will undergo screening and extensive evaluations including fitness and strength tests, blood tests, muscle biopsies, and surveys. Researchers will assess changes in inflammation and frailty from baseline to after the 16-week program, along with muscle loss and muscle biomarkers. Participants will be monitored for safety and adherence throughout. Total participation is expected to last about 16 weeks.
CONDITIONS
Brief Title
Debunking the Frailty-sarcopenIa-ADT Axis in mEtastatic Prostate canceR With multiComponent Exercise: The FIERCE Trial
Who Can Participate
Age: 18Years +
MALE
Eligibility Criteria
You may qualify if you...
- Ability to understand and willing to sign informed consent before any study procedures
- Diagnosed with metastatic prostate cancer
- Aged 18 years or older
- Receiving androgen deprivation therapy for at least one month and expect to continue for at least 4 months
- Pre-frail or frail based on FRAIL scale (score 1-5)
- Physician clearance to participate in exercise
- Speak English
- Participate in less than 2 resistance exercise sessions per week over the last 4 months
- Participate in 60 minutes or less of moderate-to-vigorous aerobic exercise per week over the last month
- Willing to travel to Dana-Farber Cancer Institute for data collection and exercise sessions
You will not qualify if you...
- Receiving chemotherapy
- Having unstable or severely symptomatic bone lesions
- Completing 2 or more resistance exercise sessions per week over the last 4 months
- Participating in more than 60 minutes of moderate-to-vigorous aerobic exercise per week over the last month
- Having unstable health conditions preventing moderate-to-vigorous exercise
- Receiving treatment for other active cancers except basal cell carcinoma
- Unable to comply with safety monitoring requirements as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - 16 weeks
Participants in the Exercise Group engage in a 16-week supervised multicomponent exercise program, including sessions with a certified exercise trainer and home-based aerobic exercises. Participants in the Attention Control Group continue their normal daily activities without the supervised exercise intervention.
Multiple supervised and home-based exercise sessions over 16 weeks
Follow-up
Duration - 1 week
Participants complete evaluations of fitness, physical health and strength, blood tests, muscle biopsy, and surveys at baseline and post-intervention to assess changes.
2 visits (baseline and post-intervention assessments)
Trial Site Locations
Total: 3 locations
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
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Research Team
C
Christina Dieli-Conwright, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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