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Behavioral Intervention

Exercise Program for Prostate Cancer

N/A
Recruiting
Led By Christina Dieli-Conwright, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Have unstable bone lesions. In general patients with severely symptomatic/unstable bone lesions due to bone metastases are at a higher risk of fractures
Patients receiving treatment for other active malignancies (except basal cell carcinoma). This study is exclusively targeting androgen deprivation therapy-related effects
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 0) and post-intervention (week 17)
Awards & highlights
No Placebo-Only Group

Summary

This trial is to find if it can help prostate cancer patients improve their frailty and sarcopenic status through a 16-week exercise program.

Who is the study for?
The FIERCE Trial is for English-speaking men over 18 with metastatic prostate cancer who are pre-frail or frail and on ADT. They must be willing to travel to Dana-Farber Cancer Institute, have physician clearance for exercise, and not already doing much structured exercise.
What is being tested?
This study tests a 16-week supervised circuit training program combining resistance and functional exercises with self-directed aerobic activity. It aims to see if this can improve frailty, sarcopenia (muscle loss), and disease progression in patients.
What are the potential side effects?
While the trial itself doesn't involve medication that would cause side effects, exercising may lead to muscle soreness, fatigue, or injury especially if participants are not used to physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with prostate cancer that has spread.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have bone lesions that are at high risk of fractures.
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I am not receiving treatment for any cancer other than basal cell carcinoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0) and post-intervention (week 17)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0) and post-intervention (week 17) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Circulating Inflammation for Exercise Group
Frailty
Secondary study objectives
Sarcopenia
Skeletal Muscle Biomarkers - myokines

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Exercise GroupExperimental Treatment1 Intervention
Participants will partake in a 16-week supervised exercise program.
Group II: Attention Control GroupExperimental Treatment1 Intervention
Participants will continue with their normal daily activities.

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,108 Previous Clinical Trials
357,131 Total Patients Enrolled
77 Trials studying Prostate Cancer
15,789 Patients Enrolled for Prostate Cancer
Prostate Cancer FoundationOTHER
48 Previous Clinical Trials
2,787 Total Patients Enrolled
27 Trials studying Prostate Cancer
1,900 Patients Enrolled for Prostate Cancer
Christina Dieli-Conwright, MDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
30 Total Patients Enrolled
~48 spots leftby Feb 2026
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