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Exercise for Metastatic Prostate Cancer Patients on ADT

This study, called FIERCE, is for men with metastatic prostate cancer (cancer that has spread) who are receiving androgen deprivation therapy (ADT). It's looking at whether a 16-week exercise program can help improve frailty (weakness and low energy) and sarcopenia (muscle loss), and potentially affect how the disease progresses. The exercise program involves supervised circuit training with resistance and functional exercises, plus self-directed aerobic exercises at home. Researchers will measure changes in inflammation and frailty at the beginning and end of the 16-week program to see if the exercise is successful. The study aims to enroll about 80 men aged 18 or older who have been diagnosed with metastatic prostate cancer and are willing to sign an informed consent form.

Study design
This is a pilot, randomized controlled study with about 80 participants. You would be randomly assigned to either an exercise group or an attention control group.
What's involved
Your participation would last about 16 weeks and involve extensive evaluations of fitness, physical health, and strength, blood tests, muscle biopsy, surveys, and follow-up visits.
Compensation
Not stated in the trial record.
Follow-up
Frailty and inflammation will be measured at the end of the 16-week intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06040125

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

Recruiting
NAAges 18+InterventionalSupportive care
Dana-Farber Cancer Institute
~80 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested:Supervised Circuit Training

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Circulating Inflammation for Exercise Group
Measured over Baseline (week 0) and Post-intervention (week 17)
+1 more outcome measured

Conditions

PROSTATE CANCER
Metastatic Prostate Cancer
Metastatic Prostate Carcinoma

Explore related trials

Prostate Carcinoma

Where it's being run

3 sites across 1 states
Massachusetts3

Study leadership

  • Christina Dieli-Conwright, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

Christina Dieli-Conwright, MD
[email protected]
617-582-8321
Email the study team

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Do you actually qualify for this trial?

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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.

What this trial measures

  • Change in Circulating Inflammation for Exercise GroupBaseline (week 0) and Post-intervention (week 17)

    Assessed by change in systemic inflammatory biomarkers through blood analysis (ul/ml).

  • FrailtyBaseline (week 0) and Post-intervention (week 17)

    This will be assessed by the Fried Frailty Phenotype, which measures participant ratings on a five-characteristic scale and will be totaled for an overall frailty score of 1-2, identified as prefail, or ≥3, identified as frail. Participants will receive a score of 1 (experience characteristic) or 0 (do not experience) for each characteristic.