NCT06040125Recruiting
Debunking the Frailty-sarcopenIa-ADT Axis in mEtastatic Prostate canceR With multiComponent Exercise: The FIERCE Trial
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 10 Aug 2023
- Start date
- 1 Jan 2024
- Primary completion date
- 28 Aug 2027
- Lead sponsor
- Dana-Farber Cancer Institute
- Diseases
- Prostate cancer
- NCT number
- NCT06040125
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 1 Jan 2024 to the primary completion date, 28 Aug 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving chemotherapy. This study is exclusively targeting androgen deprivation therapy-related effects.
- Patients receiving treatment for other active malignancies (except basal cell carcinoma). This study is exclusively targeting androgen deprivation therapy-related effects.
Other
- 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.
- Subjects who in the opinion of the investigators may not be able to comply with the safety monitoring requirements of the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Not yet recruiting |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Not yet recruiting |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
Related publications
- Design of debunking the frailty-sarcopenia-ADT axis in metastatic prostate cancer with multicomponent exercise: the FIERCE trial protocol.Front Sports Act Living · 2025 · PMID 41210271
This page is information, not medical advice. Discuss any trial with your doctor.