Debunking the Frailty-sarcopenIa-ADT Axis in mEtastatic Prostate canceR With multiComponent Exercise: The FIERCE Trial
1 other identifier
interventional
80
1 country
3
Brief Summary
The purpose of this study is to determine whether a 16-week supervised, clinic-based circuit training intervention utilizing resistance and functional exercises and self-directed aerobic exercise will improve frailty and sarcopenic status and disease progression outcomes among pre-frail/frail metastatic prostate cancer patients receiving androgen deprivation therapy (ADT). The names of the study intervention involved in this study is: • Supervised circuit training (aerobic and resistance exercise regimen)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started Jan 2024
Typical duration for not_applicable prostate-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2023
CompletedFirst Posted
Study publicly available on registry
September 15, 2023
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
March 11, 2026
March 1, 2026
2.7 years
August 10, 2023
March 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Circulating Inflammation for Exercise Group
Assessed by change in systemic inflammatory biomarkers through blood analysis (ul/ml).
Baseline (week 0) and Post-intervention (week 17)
Frailty
This will be assessed by the Fried Frailty Phenotype, which measures participant ratings on a five-characteristic scale and will be totaled for an overall frailty score of 1-2, identified as prefail, or ≥3, identified as frail. Participants will receive a score of 1 (experience characteristic) or 0 (do not experience) for each characteristic.
Baseline (week 0) and Post-intervention (week 17)
Secondary Outcomes (2)
Sarcopenia
Baseline (week 0) and Post-intervention (week 17)
Skeletal Muscle Biomarkers - myokines
Baseline (week 0) and Post-intervention (week 17)
Study Arms (2)
Exercise Group
EXPERIMENTALParticipants will partake in a 16-week supervised exercise program.
Attention Control Group
EXPERIMENTALParticipants will continue with their normal daily activities.
Interventions
16-week, multicomponent exercise intervention comprised of sessions supervised by certified exercise oncology trainer and home-based, self-directed aerobic exercises. Stationary bike and accelerometer (activity/heart rate monitor) will be provided.
Eligibility Criteria
You may qualify if:
- Ability to understand and the willingness to sign informed consent prior to any study-related procedures.
- Diagnosed with metastatic prostate cancer.
- Aged ≥18 years; due to the rarity of the disease in those \<18 years, this age bracket will not be included.
- Have been receiving androgen deprivation (either with or without androgen receptor targeted treatment) for at least one month and expect to remain on their treatment for at least 4 months.
- Are pre-frail or frail as indicated by the FRAIL scale (a score of 1-2 = pre-frail; 3-5 = frail).
- Have physician's clearance to participate in exercise.
- Speak English.
- Participate in less than 2 structured resistance exercise sessions per week over the last 4 months.
- Participate in less than or equal to 60 minutes of moderate-to-vigorous aerobic exercise per week over the last month.
- Willing to travel to Dana-Farber Cancer Institute for necessary data collection and exercise sessions.
You may not qualify if:
- Receiving chemotherapy. This study is exclusively targeting androgen deprivation therapy-related effects.
- Have unstable bone lesions. In general patients with severely symptomatic/unstable bone lesions due to bone metastases are at a higher risk of fractures.
- Complete 2 or more structured resistance exercise sessions per week over the last 4 months and participate in more than 60 minutes of moderate-to-vigorous aerobic exercise per week over the last month. Excess additional exercise is a confounding factor in assessing the effect of the current exercise program.
- Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities likely require supervised exercise for safety, and part of this study involves unsupervised exercise; therefore, for safety reasons, these persons are excluded.
- Patients receiving treatment for other active malignancies (except basal cell carcinoma). This study is exclusively targeting androgen deprivation therapy-related effects.
- Subjects who in the opinion of the investigators may not be able to comply with the safety monitoring requirements of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Prostate Cancer Foundationcollaborator
Study Sites (3)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Related Publications (1)
Wilson RL, Vulczak A, Morgans AK, Norris M, Greer J, Votta J, Vamvini M, Einstein DJ, Uno H, Rosenthal M, Vander Heiden MG, Dieli-Conwright CM. Design of debunking the frailty-sarcopenia-ADT axis in metastatic prostate cancer with multicomponent exercise: the FIERCE trial protocol. Front Sports Act Living. 2025 Oct 23;7:1602123. doi: 10.3389/fspor.2025.1602123. eCollection 2025.
PMID: 41210271DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christina Dieli-Conwright, MD
Dana-Farber Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
August 10, 2023
First Posted
September 15, 2023
Study Start
January 1, 2024
Primary Completion (Estimated)
August 28, 2026
Study Completion (Estimated)
February 28, 2027
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.