drugset / Trial / NCT07617272
Prostate Androgen Response Investigation Using a Stratification BIOmarker; Predicting Prostate Cancer Downstaging by Neoadjuvant Darolutamide With PCAI ImmunoScore
Phase 2
Recruiting
100 enrolled
Region Stockholm
Bayer · collabInnovative Health Initiative - European Union · collabOHMX.bio · collabPhilips Intellectual Property & Standards · collabSahlgrenska University Hospital · collab
NaSingle-groupOpen-labelOther
Summary
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.
Timeline
- Start
- 2025-11-09
- Primary completion
- 2027-06
- Completion
- 2030-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darolutamide | Other / unclassified | 600 mg | Oral |