The PARIS-BIO study evaluates whether a novel genomic biomarker, the PCAI ImmunoScore, can predict the response to neoadjuvant treatment with Darolutamide in patients with high-risk localized or locally advanced prostate cancer. Patients will receive Darolutamide monotherapy for 90-120 days prior to radical prostatectomy. The study aims to validate if the biomarker can identify patients who achieve Minimal Residual Disease (MRD) at the time of surgery.
Biopsy-confirmed high-risk prostate cancer defined as: Global ISUP score > 3 with any MRI PI-RADS score OR Global ISUP score = 3 with MRI PI-RADS score = 5
Candidate for radical prostatectomy
Clinical prostate MRI not older than 3 months at screening
ECOG performance status score of 0 or 1
Metastatic (M1) or node-positive (N2) disease
Prior treatment with androgen receptor antagonists
Prior treatment with gonadotropin-releasing hormone (GnRH)
History of prior systemic or local therapy for prostate cancer (including radiation and focal therapy)
Region Stockholm
Lead sponsor
Sahlgrenska University Hospital
Collaborator
Philips Intellectual Property & Standards
Collaborator
OHMX.bio
Collaborator
Innovative Health Initiative - European Union
Collaborator
Bayer
Collaborator