European Urology Today, the official newsletter of the European Association of Urology, publishes the results of the PCombi study
Pantarhei Oncology has developed a new concept for the endocrine treatment of locally infiltrating and/or metastatic prostate cancer in collaboration with two renowned Dutch urologists, Prof. Frans Debruyne, formerly at the Radboud UMC, Nijmegen and Prof. Jeroen van Moorselaar, Free University, Amsterdam. This collaboration has resulted in the performance of the prospective, randomized, double-blind, placebo-controlled PCombi study in four Dutch urology centers by Dr. Erik Roos (Sneek), Dr. Rik Somford (Nijmegen), Dr. Ton Roeleveld (Alkmaar) and Dr. Tjard de Haan (Zwolle) in men with advanced prostate cancer, who started androgen deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) agonist to suppress testosterone levels. Major side effects of ADT are loss of libido and sexual function, but since the loss of testosterone also implies the loss of testosterone derived estrogens, especially estradiol (E2), most side effects of ADT are related to estrogen deficiency. These side effects are the same as the symptoms of estrogen deficiency occurring in postmenopausal women and include hot flushes and sweatings, joint pain (arthralgia), sleep disturbances, mood changes and depression, fatigue, loss of energy, muscle weakness (sarcopenia), cognition problems, bone loss and an increased fracture risk with, especially in aging males, a higher risk of mortality.
The results of the Phase II PCombi study were recently published in the European Urology Open Science. The study has demonstrated several significant estrogen supplmentation and biochemical anti-tumor effects. Patients treated with E4 had fewer symptoms of estrogen deficiency than patients treated with placebo. The high dose E4 treatment was well-tolerated with no treatment-related cardiovascular adverse events.
European Urology Today, the official newsletter of the European Association of Urology, now reports on this publication: European Urology Today Vol. 33 No.5 – October 2021/ January 2022 by European Association of Urology (EAU) – Issue.