Tests a biomarker to predict response to darolutamide before prostate surgery
Tests darolutamide before surgery in adults with high-risk prostate cancer.
Plain-language title generated from the registry record
Registry title: Prostate Androgen Response Investigation Using a Stratification BIOmarker; Predicting Prostate Cancer Downstaging by Neoadjuvant Darolutamide With PCAI ImmunoScore
Key facts
- Where
- Goteborg and Solna, SwedenSee the 2 sites
- Phase
- Phase 2
Where in Sweden
- Sahlgrenska University Hospital-Vaestra GoetalandsregionenGoteborg, SwedenTaking people
- Karolinska University HospitalSolna, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Stockholm
- Trial code
- NCT07617272EU 2025-520639-17-00
- Record updated
- 1 June 2026
- Original description
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.Read full original descriptionShow less
PARIS-BIO - Prostate Androgen Response Investigation Using a Stratification BIOmarker; Predicting Prostate Cancer Downstaging by Neoadjuvant Darolutamide With PCAI ImmunoScore in a Non-randomised Open Label Prospective Trial
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.
Inclusion: 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; Able to receive Darolutamide for 90-120 days; Signed informed consent form; Willingness to use contraception if sexually active.
Exclusion: 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); Major surgery <4 weeks prior to inclusion; Metastatic (M1) or node-positive (N2) disease.