Status:
RECRUITING
Debunking the Frailty-sarcopenIa-ADT Axis in mEtastatic Prostate canceR With multiComponent Exercise: The FIERCE Trial
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Prostate Cancer Foundation
Conditions:
PROSTATE CANCER
Metastatic Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06040125
Start Date
January 1 2024
End Date
February 28 2027
Last Update
February 27 2025
Active Locations (3)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215