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

ClinicalTrials.gov ID

NCT07617272

Lead Sponsor

Region StockholmOTHER_GOV

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

100Estimated

Last Update Posted

Jun 1, 2026Actual

Start Date

Nov 9, 2025Actual

Primary Completion Date

Jun 2027Estimated

Completion Date

Dec 2030Estimated

Official Title

PARIS-BIO - Prostate Androgen Response Investigation Using a Stratification BIOmarker; Predicting Prostate Cancer Downstaging by Neoadjuvant Darolutamide With PCAI ImmunoScore in a Non-randomised Open Label Prospective Trial

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.

Detailed Description

High-risk prostate cancer patients are at risk for recurrence after local therapy. The presence of micro-metastatic disease, undetectable by conventional imaging, likely contributes to the poor prognosis. Neoadjuvant hormonal therapy, particularly with the advent of ARPIs like Darolutamide, has shown promise, but patient selection remains crucial for optimizing outcomes. This Phase II, single-arm, open-label trial investigates the predictive value of the PCAI ImmunoScore, a gene expression signature derived from diagnostic biopsies.

100 participants with high-risk prostate cancer scheduled for radical prostatectomy will be enrolled. They will receive Darolutamide (600 mg twice daily) for a period of 90 to 120 days. MRI imaging will be performed between day 90 and 120 prior to surgery. Radical prostatectomy is performed within the same window.

The primary analysis compares the pre-treatment biomarker score with the pathological response (Minimal Residual Disease) observed in the surgical specimen. Secondary analyses include MRI response, PSA kinetics, and patient-reported functional outcomes.

• Prostate Cancer (Adenocarcinoma)

• Darolutamide
• Radical prostatectomy

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Male

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Other

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Region StockholmOTHER_GOV

Collaborators

Sahlgrenska University HospitalOTHER

Philips Intellectual Property & StandardsUNKNOWN

OHMX.bioUNKNOWN

European UnionOTHER

BayerINDUSTRY

johan.bjorklund@regionstockholm.se+46(0)709583113

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