Predicting prostate cancer response to neoadjuvant darolutamide with a gene biomarker

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, single-arm trial enrolls 100 men with high-risk localized or locally advanced prostate cancer who are candidates for radical prostatectomy. Participants receive darolutamide 600 mg twice daily for 90 to 120 days, with MRI performed before surgery. The study aims to see if the PCAI ImmunoScore, derived from diagnostic biopsies, can predict pathological response at prostatectomy, defined as minimal residual disease. Secondary analyses include MRI response, PSA kinetics, and patient-reported functional outcomes. The investigation is conducted at major Swedish centers with regional collaboration to validate a genomic biomarker for treatment stratification.

Why it matters

Who can join: the full rules

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

Where it's running

• Sahlgrenska University Hospital
  Gothenburg, Sweden Recruiting
• Karolinska University Hospital
  Stockholm, Sweden Recruiting

Study contacts

• Principal investigator: Peter N Wiklund, MD, Professor — Region Stockholm represented by Karolinska University Hospital
• Study coordinator: Per H Vincent, MScEng, PhD
• Email: per.vincent@regionstockholm.se
• Phone: +46(0)708239320

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.