Clinical trial · Interventional
Debunking the Frailty-sarcopenIa-ADT Axis in mEtastatic Prostate canceR With multiComponent Exercise: The FIERCE Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
| PROSTATE CANCER | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Supervised Circuit Training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise Group
- description
- Participants will partake in a 16-week supervised exercise program.
- interventionNames
- Behavioral: Supervised Circuit Training
- type
- EXPERIMENTAL
- label
- Attention Control Group
- description
- Participants will continue with their normal daily activities.
- interventionNames
- Behavioral: Supervised Circuit Training
Primary outcomes (2)
- measure
- Change in Circulating Inflammation for Exercise Group
- timeFrame
- Baseline (week 0) and Post-intervention (week 17)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (1)
- DERIVEDWilson 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 41210271