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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorDana-Farber Cancer Institute

About this trial

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)

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Supervised Circuit Training

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Dana-Farber Cancer Institute

Lead sponsor

Prostate Cancer Foundation

Collaborator