Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT06040125

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

Led by Dana-Farber Cancer Institute · Updated on 2026-03-11

80

Participants Needed

3

Research Sites

164 weeks

Total Duration

On this page

Sponsors

D

Dana-Farber Cancer Institute

Lead Sponsor

P

Prostate Cancer Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand and willingness to sign informed consent before any study procedures
  • Diagnosed with metastatic prostate cancer
  • Age 18 years or older
  • Receiving androgen deprivation therapy (with or without androgen receptor targeted treatment) for at least one month and expected to continue for at least 4 months
  • Pre-frail or frail based on the FRAIL scale (score 1-2 = pre-frail; 3-5 = frail)
  • Physician clearance to participate in exercise
  • Speak English
  • Engaged in less than 2 structured resistance exercise sessions per week in the last 4 months
  • Participated in 60 minutes or less of moderate-to-vigorous aerobic exercise per week in the last month
  • Willing to travel to Dana-Farber Cancer Institute for data collection and exercise sessions
Not Eligible

You will not qualify if you...

  • Currently receiving chemotherapy
  • Have unstable bone lesions or severely symptomatic bone metastases
  • Completed 2 or more resistance exercise sessions per week in the last 4 months and more than 60 minutes of moderate-to-vigorous aerobic exercise per week in the last month
  • Have unstable comorbidities that prevent moderate-to-vigorous intensity exercise
  • Receiving treatment for other active cancers (except basal cell carcinoma)
  • Unable to comply with study safety monitoring requirements according to investigators

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Not Yet Recruiting

2

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02215

Actively Recruiting

3

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Not Yet Recruiting

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Research Team

C

Christina Dieli-Conwright, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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