Comparing Acupuncture vs. Sham Acupuncture for the Management of Hot Flashes in Prostate Cancer Patients Receiving Hormone Therapy
This study is evaluating whether acupuncture may help reduce hot flashes in men receiving hormone therapy for prostate cancer. Hot flashes are a common side effect of androgen deprivation therapy (ADT) and may negatively affect sleep, mood, concentration, daily activities, and overall quality of life. Participants enrolled in this study will receive acupuncture treatment over a defined treatment period. The study will assess changes in hot flash frequency, severity, and quality of life using patient questionnaires and symptom diaries. Participants will complete a daily hot flash diary during selected 7-day assessment periods and quality-of-life questionnaires during study visits. The primary goal of this study is to determine whether acupuncture may improve hot flash symptoms and related quality of life in men undergoing treatment for prostate cancer.
• Patients with history of prostate cancer with currently receiving hormone therapy or had received hormone therapy in the past two years
• Hormone therapies may include androgen deprivation therapy ( ADT; e.g., leuprolide, degarelix, or relugolix) or androgen signaling inhibitors (e.g., enzalutamide, apalutamide, or darolutamide) or adrenal steroid synthesis inhibitor (e.g., abiraterone acetate).
• Patients may also receive additional treatments such as chemotherapy, radioligand therapy or target therapy in combination with hormone therapy.
• Reports hot flashes at least twice per day. Patients may already be taking medications for hot flashes. There is no limit on the number of hot flash medications they can be using.
• ECOG performance status =3 (see Appendix A).
• Patients may participate in other therapeutic clinical trials for the treatment of prostate cancer. They will remain eligible as long as they meet the eligible criteria.
• Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
• Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
• Patients with a prior or concurrent malignancy are eligible for this trial.
• Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.