2.1. Study design and patients

This randomized, double-blind, placebo-controlled, phase 2, proof-of-concept study was conducted from March 2018 until May 2020 at four sites in the Netherlands (ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT03361969","term_id":"NCT03361969"}}NCT03361969; EudraCT 2017-003708-34). Male patients (aged ≥18 yr; body mass index 18.0–35.0 kg/m²) recently diagnosed with locally advanced or metastatic PCa qualifying for treatment with an LHRH agonist were suitable for enrollment if they had an Eastern Cooperative Oncology Group (ECOG) performance status of 0–1 [15] and life expectancy of at least 2 yr. Patients who had received any medical therapy for PCa in the last year and patients with a history of venous or arterial thromboembolic events or CV disease were excluded from participation unless they were on treatment with anticoagulants for ≥6 mo and were willing to continue anticoagulant treatment during the study. Patients with a known defect in the blood coagulation system could also not participate.