Prostate Androgen Response Investigation Using a Stratification BIOmarker; Predicting Prostate Cancer Downstaging by Neoadjuvant Darolutamide With PCAI ImmunoScore
Recruiting now · Phase 2
Conditions studied: Prostate Cancer (Adenocarcinoma)
In brief
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.
Key facts
- Study ID
- NCT07617272
- Run by
- Region Stockholm
- People needed
- 100
- Starts
- 2025-11-09
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2026-06-01
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
- Major surgery <4 weeks prior to inclusion
Where it is running
- Sahlgrenska University Hospital — Gothenburg, Sweden (enrolling)
- Karolinska University Hospital — Stockholm, Sweden (enrolling)
Full record on ClinicalTrials.gov
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