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PROSTATE CANCERNCT06040125

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

A study testing Supervised Circuit Training in people with PROSTATE CANCER and Metastatic Prostate Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Supervised Circuit Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
3 sitesUnited States
Study dates
1 Jan 2024to 28 Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Christina Dieli-Conwright, MD contact

617-582-8321

ChristinaM_Dieli-Conwright@dfci.harvard.edu

United States3 sites, 3 recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    David Einstein, MD, (617) 667-1957, Deinstei@bidmc.harvard.edu

    David Einstein, MD

    Not yet recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02215

    Christina Dieli-Conwright, PhD, MPH, 617-582-8321, ChristinaM_Dieli-Conwright@DFCI.HARVARD.EDU

    Christina Dieli-Conwright, PhD, MPH

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Christina Dieli-Conwright, MD, 617-582-8321, ChristinaM_Dieli-Conwright@dfci.harvard.edu

    Not yet recruiting

Other trials in United States

About this study

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)
Read the 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.

Being tested
Supervised Circuit Training
Keywords
Prostate Cancer, Metastatic Prostate Cancer, Metastatic Prostate Carcinoma
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supervised Circuit TrainingBehavioural

    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.

Study groups in NCT06040125
Study groupRoleWhat they receive
Exercise GroupExperimentalParticipants will partake in a 16-week supervised exercise program.
Receives: Behavioral: Supervised Circuit Training
Attention Control GroupExperimentalParticipants will continue with their normal daily activities.
Receives: Behavioral: Supervised Circuit Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Circulating Inflammation for Exercise Group

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

    Measured: Baseline (week 0) and Post-intervention (week 17)

  2. Frailty

    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.

    Measured: Baseline (week 0) and Post-intervention (week 17)

Secondary outcomes (2)

  1. Sarcopenia

    A sarcopenia score of ≤10.75 kg/m2, as assessed by computed tomography (CT), will be the cut point used for identifying muscle loss = 1 point.

    Measured: Baseline (week 0) and Post-intervention (week 17)

  2. Skeletal Muscle Biomarkers - myokines

    Assessed from muscle biopsy specimens of the vastus lateralis (ul/ml).

    Measured: Baseline (week 0) and Post-intervention (week 17)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2023
  2. Study start1 Jan 2024
  3. Primary completion28 Aug 2027 (estimated)
  4. Study completion28 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06040125
Sponsor's protocol ID
23-109
Status last verified
Sep 2026
First submitted
10 Aug 2023
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Publications

  • Wilson RL, Vulczak A, Morgans AK, Norris M, Greer J, Votta J, Vamvini M, Einstein DJ, Uno H, Rosenthal M, Vander Heiden MG, Dieli-Conwright CM. Design of debunking the frailty-sarcopenia-ADT axis in metastatic prostate cancer with multicomponent exercise: the FIERCE trial protocol. Front Sports Act Living. 2025 Oct 23;7:1602123. doi: 10.3389/fspor.2025.1602123. eCollection 2025.

    PubMed 41210271

Questions about this trial

What is this clinical trial studying?

A study testing Supervised Circuit Training in people with PROSTATE CANCER and Metastatic Prostate Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christina Dieli-Conwright, MD (617-582-8321, ChristinaM_Dieli-Conwright@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Circulating Inflammation for Exercise Group (time frame: Baseline (week 0) and Post-intervention (week 17)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06040125, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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