Prostate Androgen Response Investigation Using a Stratification BIOmarker; Predicting Prostate Cancer Downstaging by Neoadjuvant Darolutamide With PCAI ImmunoScore

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.

NCT Number	NCT07617272
Lead Sponsor	Region Stockholm Collaborators: Sahlgrenska University Hospital, Philips Intellectual Property & Standards, OHMX.bio, European Union, Bayer
Conditions	Prostate Cancer (Adenocarcinoma)
Enrollment	100 participants
Start Date	2025-11-09
Primary Completion	2027-06 (estimated)
Study Completion	2030-12 (estimated)
Updated on ClinicalTrials.gov	2026-06-01