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

NCT07617272 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-06-01

No results posted yet for this study

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.

Conditions

  • Prostate Cancer (Adenocarcinoma)

Interventions

DRUG

Darolutamide

Neoadjuvant Darolutamide alone (without ADT) 2x300 mg orally twice daily is given to all study subjects for 90-120 days prior to prostatectomy.

PROCEDURE

Radical prostatectomy

Robot-assisted radical prostatectomy, with or without extirpation of pelvic lymph nodes according to clinician's choice in concordance with local guidelines

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Philips Intellectual Property & Standards

    collaborator UNKNOWN

  • OHMX.bio

    collaborator UNKNOWN

  • European Union

    collaborator OTHER

  • Bayer

    collaborator INDUSTRY

  • Region Stockholm

    lead OTHER_GOV

Principal Investigators

  • Peter N Wiklund, MD, Professor · Region Stockholm represented by Karolinska University Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-09
Primary Completion
2027-06-30
Completion
2030-12-31

Countries

  • Sweden

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07617272 on ClinicalTrials.gov