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

NCT07617272 | Recruiting Phase 2

• 2 other identifiers: 5.1.1-2025-0274832025-520639-17-00
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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)

Keywords

Prostate cancer; Neoadjuvant; Darolutamide; ARPI; Prediction of treatment response

Outcome Measures

Primary Outcomes (1)

• The association between the pre-treatment probability of treatment response given by PCAI ImmunoScore and the occurrence of minimal residual disease (MRD)

  The primary outcome is the association between the pre-treatment PCAI ImmunoScore and the occurrence of minimal residual disease (MRD) after 90-120 days of neoadjuvant Darolutamide treatment. MRD is defined as \< 0.05 cm3 residual tumour on final pathology after prostatectomy. The study endpoint MRD will be dichotomized into responder (if MRD is met) or non-responder (if MRD is not met) as input for the statistical data analysis. This classification (ground truth) will be tested in AUROC analysis against the calculated PCAI ImmunoScore-based probability p (0\<p\<1) of Darolutamide response. PCAI ImmunScore is calculated from RNA sequencing of tumor material from diagnostic (pre-treatment) biopsies. The collection of RNA and calculation of PCAI ImmunoScore will take place after the recruitment period. Sequencing will be performed in bulk once all samples have been collected. The objective is to assess the predictive value of the pre-treatment genomic biomarker for pathological response.

  MRD is ascertained shortly after radical prostatectomy (day 90-120). PCAI ImmunoScore will be ascertained after bulk sequencing of all samples, tentatively 1 year after surgery of the 100th study subject. The association will be calculated thereafter.

Secondary Outcomes (8)

• The association between PCAI ImmunoScore and pathologic complete response (pCR)

  pCR is ascertained shortly after radical prostatectomy (day 90-120). PCAI ImmunoScore will be ascertained after bulk sequencing of all samples, tentatively 1 year after surgery of the 100th study subject. The association will be calculated thereafter.

• Pathological T-stage (pT-stage)

  Pathological T-stage will be ascertained shortly after radical prostatectomy (day 90-120)

• Residual tumor size

  At the time of radical prostatectomy (day 90-120)

• PSA Kinetics

  Baseline, Day 30, Day 60, Day 90, and within 4 weeks after surgery

• Hormonal side effects

  From baseline up to 12 months post-surgery

Study Arms (1)

Neoadjuvant Darolutamide

EXPERIMENTAL

All participants receive Darolutamide 600 mg orally twice daily for 90-120 days prior to radical prostatectomy

Drug: Darolutamide; Procedure: Radical prostatectomy

Interventions

Darolutamide DRUG

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

Also known as: Neoadjuvant ARPI, Nubeqa

Neoadjuvant Darolutamide

Radical prostatectomy PROCEDURE

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

Also known as: RALP, RARP, Robot-assisted prostatectomy

Neoadjuvant Darolutamide

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• OHMX.bio: collaborator
• Bayer: collaborator
• Region Stockholm: lead
• Sahlgrenska University Hospital: collaborator
• Philips Intellectual Property & Standards: collaborator
• Innovative Health Initiative - European Union: collaborator

Study Sites (2)

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Karolinska University Hospital

Stockholm, SE-17176, Sweden

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Interventions

darolutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Peter N Wiklund, MD, Professor

  Region Stockholm represented by Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Per H Vincent, MScEng, PhD

CONTACT

+46(0)708239320; per.vincent@regionstockholm.se

Sara Göransson, PhD

CONTACT

+46(0)812377000; sara.goransson@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: June 1, 2026
• Study Start: November 9, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 1, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)