Debunking the Frailty-sarcopenIa-ADT axis in mEtastatic prostate canceR with multiComponent Exercise: The FIERCE 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)

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.