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Prostate Androgen Response Investigation Using a Stratification BIOmarker; Predicting Prostate Cancer Downstaging by Neoadjuvant Darolutamide With PCAI ImmunoScore (PARIS-BIO)

24. maj 2026 opdateret af: Region Stockholm

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Sverige
      • Gothenburg, Sverige
        • Rekruttering
        • Sahlgrenska University Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Johan Stranne, MD, Professor
      • Stockholm, Sverige, SE-17176

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

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Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Neoadjuvant Darolutamide
All participants receive Darolutamide 600 mg orally twice daily for 90-120 days prior to radical prostatectomy
Medicin: Darolutamide
Neoadjuvant Darolutamide alone (without ADT) 2x300 mg orally twice daily is given to all study subjects for 90-120 days prior to prostatectomy.
Andre navne:
  • Nubeqa
  • Neoadjuvant ARPI
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
Andre navne:
  • RALP
  • RARP
  • Robot-assisted prostatectomy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The association between the pre-treatment probability of treatment response given by PCAI ImmunoScore and the occurrence of minimal residual disease (MRD)
Tidsramme: 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.
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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The association between PCAI ImmunoScore and pathologic complete response (pCR)
Tidsramme: 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.
The study endpoint pCR is defined as no residual tumour visible at final pathology and will be dichotomized into responder (if pCR is met) or non-responder (if pCR 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) (baseline model) of Darolutamide response. The extended model including the additional covariates will be tested equivalent to the baseline model.
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)
Tidsramme: Pathological T-stage will be ascertained shortly after radical prostatectomy (day 90-120)
Staging of the tumor at final pathology
Pathological T-stage will be ascertained shortly after radical prostatectomy (day 90-120)
Residual tumor size
Tidsramme: At the time of radical prostatectomy (day 90-120)
Measurement of the largest cross-sectional dimensions (mm) of residual tumor
At the time of radical prostatectomy (day 90-120)
PSA Kinetics
Tidsramme: Baseline, Day 30, Day 60, Day 90, and within 4 weeks after surgery
Change in blood PSA concentration (ng/ml) during treatment
Baseline, Day 30, Day 60, Day 90, and within 4 weeks after surgery
Hormonal side effects
Tidsramme: From baseline up to 12 months post-surgery
Incidence and severity of adverse events assessed by CTCAE v5.0 and patient-reported quality-of-life using the 26-question questionnaire Expanded Prostate cancer Index Composite (EPIC-26), where lower scores indicate worse outcome
From baseline up to 12 months post-surgery
Patient-reported urinary continence
Tidsramme: Pre-surgery (day 80-119), 3 months post-surgery, 12 months post-surgery

Assessment of pre-and post-treatment urinary function using the Swedish national questionnaires (electronic patient-reported outcome measurements -ePROM "Symtom- och biverkningsenkät" that all patients undergoing prostate cancer treatment in Sweden routinely are invited to answer), where urinary continence is assessed using the question "How many protective pads do you use daily due to urine leakage?" The reply alternatives are:

None Fewer than 1 per day About 1 per day About 2 per day About 3-4 per day About 5 or more per day
Pre-surgery (day 80-119), 3 months post-surgery, 12 months post-surgery
Patient-reported erectile function
Tidsramme: Pre-surgery (day 80-119), 3 months post-surgery, 12 months post-surgery

Assessment of pre-and post-treatment erectile function using the Swedish national questionnaires (electronic patient-reported outcome measurements -ePROM "Symtom- och biverkningsenkät" that all patients undergoing prostate cancer treatment in Sweden routinely are invited to answer), where erectile function is assessed using the question "How would you describe your erection?" The reply alternatives are:

No noticeable filling or firmness Some filling, but not sufficient for full function Moderate firmness Full firmness
Pre-surgery (day 80-119), 3 months post-surgery, 12 months post-surgery
MRI tumor response
Tidsramme: Pre-surgery (day 90-120)
Change in tumor size and Extraprostatic Extension (EPE) score (Likert scale 1-5) on MRI compared to baseline MRI
Pre-surgery (day 90-120)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Region Stockholm

Samarbejdspartnere

Bayer
Sahlgrenska University Hospital
Philips Intellectual Property & Standards
OHMX.bio
Innovative Health Initiative - European Union

Efterforskere

  • Ledende efterforsker: Peter N Wiklund, MD, Professor, Region Stockholm represented by Karolinska University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

9. november 2025

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. december 2030

Datoer for studieregistrering

Først indsendt

12. december 2025

Først indsendt, der opfyldte QC-kriterier

24. maj 2026

Først opslået (Faktiske)

1. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. maj 2026

Sidst verificeret

1. november 2025

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 5.1.1-2025-027483
  • 2025-520639-17-00 (Ctis)

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