Introduction
Patients and methods
The AVAIL study design
Patients
Inclusion criteria
1. Men aging from 18 to 75 years with histologically confirmed primary invasive carcinoma of the prostate 2. Receiving a stable dose of hormonal therapy for at least 4 weeks before the study with plans to continue for at least an additional 6 weeks after participation to the AVAIL study 3. With at least 14 or more times hot flashes per week during screening 4. Patients did not receive acupuncture before 5. Patients have an estimated survival time of at least 1 year |
Exclusion criteria
1. The patient did not recover from side-effects of the surgery on the prostate 2. Patients with cognitive dysfunction who cannot cooperate with treatment and assessment 3. Use of drugs that may affect hot flashes symptoms: androgens, estrogens, progestational agents, gabapentin, pregabalin within the past 3 months. Antidepressants will be allowed if the patient had been on a stable dose for at least 1 month and did not plan to modify this treatment during the ensuing 14 weeks. |
Verum acupuncture
Sham acupuncture
Usual care
Allocation
Masking and blinding assessment
Outcomes
Primary endpoint
Change from baseline to 6 weeks for the HFSSS |
Secondary endpoints
1. Change from baseline to 2, 4, 10, and 14 weeks for the HFSSS 2. Change from baseline to 2, 4, 6, 10, and 14 weeks for the frequency of hot flashes 3. Changes from baseline to 2, 4, 6, 10, and 14 weeks for the severity of hot flashes 4. The proportion of responders (at least a 50% reduction in the HFSSS) at 6, 10, and 14 weeks 5. Changes from baseline to 6, 10, and 14 weeks for the FACT-P 6. Changes from baseline to 6, 10, and 14 weeks for the IIEF-5 7. Changes from baseline to 6, 10, and 14 weeks for the SAS 8. Changes from baseline to 6, 10, and 14 weeks for the SDS |