A phase II salvage trial of transdermal estradiol in the treatment of hormone and chemotherapy refractory prostate cancer: A Cancer Institute of New Jersey Oncology Group Study NJ1803

4695 Background: Options for patients with progression of prostate cancer following androgen ablation and chemotherapy are limited. Prior studies have demonstrated the efficacy of estrogen in this group of patients, but safe and effective agents are limited. Given prior data demonstrating the safety and ease of using an estradiol patch, we tested the hypothesis that the patch would be a safe and effective option for patients with hormone and chemotherapy refractory prostate cancer. Methods: In this ongoing study, ten patients with hormone refractory prostate cancer who had progressed after at least one chemotherapy regimen were enrolled. Patients were treated with two transdermal patches (total daily dose: 0.2 mg of estradiol) changed weekly. Results: 7/10 patients received one prior and 3/10 two or more prior chemotherapy regimens. Median age was 64 years (range 57 to 76). Prostate specific antigen (PSA) decreased in 5/10 patients (mean decrease 27%). 2/3 patients that were treated for at least 3 months ...