Exercise program to improve health in men with metastatic prostate cancer
Debunking the Frailty-sarcopenIa-ADT Axis in mEtastatic Prostate canceR With multiComponent Exercise: The FIERCE Trial
This study is testing whether a 16-week exercise program can help men with metastatic prostate cancer feel stronger and healthier while they are receiving treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Boston, Massachusetts and 2 other locations) |
| Trial ID | NCT06040125 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of a 16-week supervised circuit training program, which includes resistance and functional exercises along with self-directed aerobic activities, on frailty and sarcopenic status in pre-frail and frail patients with metastatic prostate cancer undergoing androgen deprivation therapy. Participants will be randomly assigned to either an exercise group or an attention control group, with comprehensive evaluations including fitness assessments, blood tests, and muscle biopsies conducted throughout the study. The goal is to determine if this exercise intervention can positively influence health outcomes and disease progression in this patient population.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with metastatic prostate cancer who are pre-frail or frail and receiving androgen deprivation therapy.
Not a fit: Patients who are not pre-frail or frail, or those who have been participating in regular structured exercise, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance physical health and potentially slow disease progression in men with metastatic prostate cancer.
How similar studies have performed: While this specific intervention is novel, similar studies have shown positive outcomes with exercise programs in cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Boston, Massachusetts and 2 other locations
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Not_yet_recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Christina Dieli-Conwright, MD — Dana-Farber Cancer Institute
- Study coordinator: Christina Dieli-Conwright, MD
- Email: ChristinaM_Dieli-Conwright@dfci.harvard.edu
- Phone: 617-582-8321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.