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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Biopsies, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a 16-week exercise program can improve weakness, muscle loss, and how prostate cancer worsens over time. It is for adults with prostate cancer that has spread who are frail or at risk of becoming frail and take hormone-lowering treatment called ADT. The program includes supervised strength and daily-movement exercises at a clinic, plus aerobic exercise done on your own.

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)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 and have prostate cancer that has spread to other parts of the body.
  • Understand the study and agree to sign a consent form before any study procedures.
  • Have taken ADT, a treatment that lowers male hormones, for at least 1 month and expect to stay on it for at least 4 more months.
  • Be frail or at risk of becoming frail, with a score of 1–5 on the FRAIL screening tool.
  • Have a doctor's approval to exercise.
  • Speak English and be willing to travel to Dana-Farber Cancer Institute for study visits and exercise sessions.
  • Have done fewer than 2 planned strength-training sessions per week over the last 4 months.
  • Have done no more than 60 minutes per week of moderate-to-hard aerobic exercise over the last month.

Who can't join

  • Be receiving chemotherapy.
  • Have unstable areas of bone damage from cancer that may raise the risk of broken bones.
  • Have done at least 2 planned strength-training sessions per week over the last 4 months AND more than 60 minutes of moderate-to-hard aerobic exercise per week over the last month.
  • Have other health problems that are not stable and prevent safe moderate-to-hard exercise.
  • Be receiving treatment for another active cancer, except basal cell skin cancer.
  • The study team thinks you may not be able to follow the study's safety-check requirements.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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.

Study sites (3)

MA