Exercise program to improve health in men with metastatic prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study investigates the effects of a 16-week supervised circuit training program, which includes resistance and functional exercises along with self-directed aerobic activities, on frailty and sarcopenic status in pre-frail and frail patients with metastatic prostate cancer undergoing androgen deprivation therapy. Participants will be randomly assigned to either an exercise group or an attention control group, with comprehensive evaluations including fitness assessments, blood tests, and muscle biopsies conducted throughout the study. The goal is to determine if this exercise intervention can positively influence health outcomes and disease progression in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting
• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Not yet recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Not yet recruiting

Study contacts

• Principal investigator: Christina Dieli-Conwright, MD — Dana-Farber Cancer Institute
• Study coordinator: Christina Dieli-Conwright, MD
• Email: ChristinaM_Dieli-Conwright@dfci.harvard.edu
• Phone: 617-582-8321

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.