High-risk prostate cancer (PCa) patients frequently experience recurrence and progression after radical prostatectomy (RP). Neoadjuvant androgen deprivation therapy (ADT) has not demonstrated a clear oncological benefit and is not currently recommended.
The SUGAR trial is the first phase 2, randomised, controlled, multicentre, noncommercial, open-label study investigating single-agent perioperative darolutamide compared with the standard of care (ie, upfront RP, without neoadjuvant ADT).
SUGAR aims to randomise 240 men affected by nonmetastatic PCa, with the major eligibility criteria being International Society of Urological Pathology grade group ≥4, seminal vesicle invasion at magnetic resonance imaging and/or clinically node-positive disease. Patients in the experimental arm will undergo neoadjuvant darolutamide monotherapy, RP, and adjuvant darolutamide, completing 9 mo of treatment.
The primary endpoint is noncurable recurrence-free survival, an innovative and clinically meaningful measure; the secondary endpoints encompass safety; recurrence-free, metastasis-free, and overall survival; pathological response; and quality of life. A predictive biomarker analysis will also be performed.
Initial data suggest that intensified neoadjuvant treatment with androgen receptor signalling inhibitors (ARSIs) is associated with a sustained pathological response and may improve outcomes, via tumour downstaging and micrometastasis eradication. ARSI monotherapy could further enhance tolerability.
SUGAR will provide efficacy and safety information on perioperative darolutamide monotherapy compared with upfront RP, in a contemporary high-risk PCa population undergoing surgery.
The on-going SUGAR clinical trial evaluates 9 mo of darolutamide treatment in addition to radical prostatectomy, in men affected by prostate cancer with specific high-risk characteristics. It investigates whether this hormonal treatment can lower the rates of noncurable recurrences, maintaining a favourable tolerability profile.
European urology oncology. 2023 Oct 06 [Epub ahead of print]
Giorgio Calleris, Thomas Filleron, Claudia Kesch, Guilhem Roubaud, Benjamin Pradère, Bastien Cabarrou, Bernard Malavaud, Morgan Roupret, Loic Mourey, Guillaume Ploussard
Department of Urology UROSUD, La Croix du Sud Hospital, Toulouse, France; Department of Urology, San Giovanni Battista Hospital, Città della Salute e della Scienza and University of Turin, Turin, Italy., Biostatistics & Health Data Science Unit, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse, France., Department of Urology UROSUD, La Croix du Sud Hospital, Toulouse, France; Department of Urology and West German Cancer Center, University Hospital Essen, Essen, Germany., Department of Oncology, Institut Bergonié, Bordeaux, France., Department of Urology UROSUD, La Croix du Sud Hospital, Toulouse, France., Surgery Department, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse, France., GRC 5 Predictive Onco-Urology Research Group and Urology Department, Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris, Sorbonne University, Paris, France., Oncology Department, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse, France., Department of Urology UROSUD, La Croix du Sud Hospital, Toulouse, France; Surgery Department, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse, France. Electronic address: .