An investigation into the efficacy and safety of Estetrol (E4) for potential use in the treatment of advanced prostate cancer demonstrated decreased testosterone levels along with acceptable safety parameters. These results suggest that E4 may be suitable for standalone or combination treatment with androgen deprivation therapy (ADT).
QPS Netherlands performed the Phase II randomized, double-blind, placebo-controlled, multiple rising dose study in healthy men on behalf of Netherlands pharma developer Pantarhei Oncology BV. The study was conducted under the supervision of T. Mensinga, MD, PhD, in accordance with the Declaration of Helsinki and the ICH Guidelines for Good Clinical Practices (NCT02718378).
E4, a natural fetal estrogen, is also under various stages of study for use in breast cancer, menopause and contraception. Its particular value in prostate cancer therapy would be its relative affordability and its lack of certain hypoestrogenic side effects (hot flashes, arthralgias, bone loss, and mood, sleep and cognitive disturbances) that can occur with other ADT therapies.
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