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

RecruitingPhase 2Ages 18 Years - anyMaleRegion Stockholm
NCT07617272 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • Darolutamide
  • Radical prostatectomy
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Where

2 sites
Sahlgrenska University Hospital
Gothenburg, Sweden
Karolinska University Hospital
Stockholm, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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