First patient randomized in the PCombi study with Estetrol in patients with prostate cancer.
On 3 May 2018 the first patient has been randomized in the phase IIA clinical study assessing efficacy and safety of the fetal estrogen estetrol (E4) in prostate cancer patients. The study is a double blind, randomised, placebo-controlled multi-center study in prostate cancer patients treated with an LHRH agonist. In total 60 patients will be enrolled at eight centers in the Netherlands.
The main objectives of this study are to evaluate the additional effect of E4 on testosterone (T) suppression (total T as well as free T) by the LHRH agonist as well as the prevention and treatment of hypoestrogenic side effects due to the concomitant suppression of estrogens.