Prostate cancer is the most common cancer among men in the United States. Many men with prostate cancer are treated with hormone therapy, also called androgen deprivation therapy (ADT). While this treatment is effective, it often causes bothersome side effects such as hot flashes, poor sleep, fatigue, and other physical and emotional symptoms. There is currently no standard treatment to help manage these side effects in men. Acupuncture is a non-drug treatment that has been shown to help reduce hot flashes and related symptoms in women receiving hormone therapy for breast cancer. However, much less is known about whether acupuncture is helpful for men receiving hormone therapy for prostate cancer. This study will test whether an acupuncture program, combined with usual lifestyle education, is feasible and acceptable for men undergoing ADT. The study will also explore whether acupuncture may help reduce hot flashes and improve related symptoms. A total of 24 men with prostate cancer receiving ADT will be randomly assigned to one of two groups: one group will begin acupuncture right away, and the other group will begin acupuncture after a delay, with regular check-ins during the waiting period. All participants will receive standard lifestyle education. Participants will be followed for about five months and will be asked to complete daily hot flash diaries, questionnaires about their symptoms and quality of life, and wear a Fitbit to track sleep. The results of this pilot study will help determine whether a larger study should be conducted to better understand the role of acupuncture in managing hormone therapy side effects in men with prostate cancer.
Male
At least 18 years of age
Histologically or cytologically confirmed adenocarcinoma of prostate of any stage I-IV
Undergoing androgen deprivation therapy (ADT) and/or androgen receptor pathway inhibitors
Severe or uncontrolled concurrent disease, infection or co-morbidity that, in the opinion of the Investigator, would make the patient inappropriate for enrollment
Known hypersensitivity to the acupuncture needles
Any condition that in the opinion of the Investigator would impair the patients' ability to comply with the study procedures
Unable to comply with study requirements
Parallel
Acupuncture
Other interventionAcupuncture is a form of alternative medicine and a component of traditional Chinese medicine (TCM) in which thin needles are inserted into the body
Lifestyle Management
Behaviorallifestyle education per usual care without acupuncture for the first 10 weeks. At week 12, they will begin the acupuncture protocol (weekly 30-minute sessions).
Study feasibility - patient enrollment
Study feasibility will be measured by patient enrollment rates, defined as the proportion of eligible patients approached about the study who consent to participate.
Study feasibility - Patient intervention engagement
Study feasibility will be measured by patient intervention engagement, defined as the proportion of enrolled patient subjects who attend at least 6 of 10 scheduled acupuncture visits.
Intervention acceptability - quantitative
Intervention acceptability will be measured using satisfaction ratings.
Intervention acceptability - qualitative
Intervention acceptability will be evaluated using thematic analysis of post-intervention semi-structured interviews.
Hot Flash Severity Score
The primary patient outcome is the weekly mean hot flash score, which is calculated by multiplying hot flash frequency by severity, as recorded in the Daily Hot Flash Diary (DHFD).
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