NCT06040125

Debunking the Frailty-sarcopenIa-ADT Axis in mEtastatic Prostate canceR With multiComponent Exercise: The FIERCE Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

This research study is a pilot, randomized control study, which is the first-time investigators are examining this intervention in this setting. Participants will be randomized into one of two study groups: Exercise Group versus Attention Control Group. Randomization means a participant is placed into a group by chance. The research study procedures include screening for eligibility, study treatment, including extensive evaluations of fitness, physical health and strength, blood tests, muscle biopsy, surveys, and follow-up visits. Participation in this research study is expected to last about 16 weeks. It is expected that about 80 people will take part in this research study. The Prostate Cancer Foundation is providing funding for this research study.

Conditions

• PROSTATE CANCER
• Metastatic Prostate Cancer
• Metastatic Prostate Carcinoma

Interventions

Type	Name	Description
BEHAVIORAL	Supervised Circuit Training	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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-08-28
• Completion: 2027-02-28
• First posted: 2023-09-15
• Last updated: 2026-03-11

Locations

3 sites across 1 country: United States