Trial ID:NCT04485767
Protocol #:20-193
Condition(s):Physical Function, Prostate Cancer
Phase:II
Principal Investigator:Basaria, Shehzad
Trial Description:
The overall goal of this study is to determine if implementing structured exercises prevent
decline in muscle mass, muscle strength and physical function in men with prostate cancer
undergoing androgen deprivation therapy (ADT). Our main hypothesis is that structured
resistance exercise training in men undergoing ADT will preserve physical function assessed
by loaded stair climbing power compared with the control group. The trial will also examine
the efficacy of the exercise regimen on muscle strength, QOL and fatigue. The findings of
this trial will lay the groundwork for definitive intervention trials to prevent frailty and
falls in these men.
Eligibility Requirements:
- Men with active Prostate Cancer who are 60 years or older.
- Hormone-naive men about to undergo medical or surgical ADT.
- Planned ADT for at least 6 months.
- Life expectancy of at least 6 months from enrollment.
- Ability and willingness to provide informed consent.
Exclusion Criteria:
- Active medical conditions affecting participation in exercise training (limiting
arthropathies, myopathies, severe peripheral vascular disease, or severe neuropathy).
- Cardiovascular disease (current angina, severe valvular disease, advanced congestive
heart failure, arrhythmias, or stroke with residual muscular weakness).
- Prior hip or knee replacement.
- History of lower extremity fracture in the past 6 months.
Protocol #: 20-193