MPOWER: A pilot trial among men with prostate cancer—Optimizing wellness by enhanced relief from hot flashes with acupuncture.

Abstract

TPS12170 Background: Prostate cancer is the most commonly diagnosed cancer among men, and advanced disease often requires androgen deprivation therapy (ADT). ADT is associated with distressing side-effects, including hot flashes, sleep disturbance, fatigue, and cognitive symptoms. Acupuncture is a nonpharmacologic intervention shown to reduce hot flashes in other hormone-treated cancers, such as breast cancer; however, standardized acupuncture protocols for men receiving ADT are lacking. The primary objective of the MPOWER trial (NCT07335224) is to evaluate the feasibility and acceptability of study procedures, recruitment strategies, and delivery of a standardized acupuncture protocol to reduce hot flashes in men with prostate cancer. Feasibility will be assessed through enrollment and intervention engagement, and acceptability through satisfaction ratings and post-intervention qualitative feedback. Secondary objectives include patient-reported hot flash frequency and severity, hot flash interference, endocrine symptoms, sleep disturbance, and health-related quality of life. Methods: This randomized study compares Immediate Start Acupuncture (IA) with an Active Comparator: Delayed-Start Acupuncture (DA), allowing all participants eventual access to the intervention, among 24 men treated with ADT and/or androgen receptor pathway inhibitors. The intervention consists of a standardized 10-week protocol with weekly 30-minute manual acupuncture sessions delivered by a certified acupuncturist with oncology expertise. All participants receive lifestyle education from a nurse navigator as part of usual care. Participants randomized to the IA arm receive the acupuncture protocol during the initial 10-week intervention period, followed by 12 weeks of follow-up without acupuncture. Participants randomized to the activate comparator DA arm will receive lifestyle education per usual care without acupuncture during the initial 10-week comparison period, with bi-weekly check-ins serving as an attention control, and then initiate the acupuncture protocol after the delay period. Study assessments integrate real-time patient-reported hot flash diaries collected via a secure mobile application for remote symptom monitoring (Locus Health), validated patient-reported outcome measures, and continuous Fitbit monitoring to capture physiologic and sleep metrics, including heart rate variability, sleep duration, and nighttime awakenings. Feasibility outcomes include enrollment rates and intervention engagement. Acceptability is assessed quantitatively at multiple time points and qualitatively through semi-structured interviews. The primary patient outcome is the Hot Flash Severity Score, calculated as weekly mean hot flash frequency multiplied by severity. Enrollment began in January 2026, with accrual expected within 12 months. Clinical trial information: NCT07335224 .