Prostate Androgen Response Investigation using a Stratification BIOmarker - PARIS-BIO

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Karolinska University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

12 Nov 2025 → ongoing

Decision date (initial)

2025-06-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Bayer AB · Philips Electronics · European Union · OHMX.Bio

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Efficacy

To retrospectively assess the predictive value of the pre-treatment genomic biomarker PCAI ImmunoScore for pathologic minimal residual disease (MRD) in patients undergoing neoadjuvant Darolutamide treatment before radical prostatectomy

Secondary objectives 4

1. To assess the association of the genomic biomarker PCAI Immunoscore with specific variables of response to neoadjuvant Darolutamide
2. To assess the correlation between Pathological response and MRI response after neoadjuvant Darolutamide.
3. To assess hormonal side effects of Darolutamide during treatment and up to 12 months after treatment start (as reported, not compared)
4. To assess functional outcomes after radical prostatectomy, such as incontinence and impotence (as reported, not compared)

Conditions and MedDRA coding

High-risk localized or locally advanced prostate adenocarcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Patients must be >= 18 years of age
2. A clinically relevant Prostate MRI
3. Biopsy confirmed high-risk prostate cancer defined as a global ISUP-score ≥4 with any MRI PIRADS score or global ISUP=3 with any MRI PIRADS score =5
4. Candidate for radical prostatectomy
5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
6. Able to receive Darolutamide for 90-120 days
7. Signed informed consent form
8. A participant who is sexually active is eligible if he is willing to use a condom from the screening visit up to 1 week after last dose of Darolutamide except if the male participant is sterile (e.g. vasectomised); the unique female sexual partner is postmenopausal, is permanently sterilized (e.g. hysterectomy or tubal ligation) or use a highly effective method of contraception (< 1% documented failure rate).
9. Able to understand and comply with planned study procedures and willing to be available for all study-required procedures, visits and calls for the duration of the study.

Exclusion criteria 5

1. ≥M1 or ≥N2
2. Prior treatment with androgen receptor antagonists
3. Treatment with gonadotropin-releasing hormone (GnRH)
4. History of prior systemic or local therapy for prostate cancer, including pelvic radiation to the prostate
5. Major surgery <=4 weeks prior to inclusion

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Association of pathological response (MRD) with the pre-treatment genomic biomarker PCAI ImmunoScore

Secondary endpoints 10

1. The associaton of the PCAI ImmunoScore with pathologic complete response (pCR)
2. The associaton of the PCAI ImmunoScore with pT-stage at final pathology
3. The associaton of the PCAI ImmunoScore with size of largest cross-sectional dimension of residual tumour on pathology
4. The associaton of the PCAI ImmunoScore with number of resection specimen slides in which the tumour can be seen on pathology
5. The associaton of the PCAI ImmunoScore with MRI assessment of changes in tumour size, cross sectional dimension, volume, and EPE
6. The associaton of the PCAI ImmunoScore with blood PSA concentration during treatment
7. Correlation between Pathological response and MRI response.
8. Hormonal side effects during and after treatment, measured through AE/SAE registration and repeated validated questionnaires as well as changes in blood testosterone concentration
9. Post- surgical functional outcomes (erectile function and urinary continence) in the cohort measured through questionnaires
10. The association of the PCAI ImmunoScore with Residual Cancer Burden (RCB), defined as residual tumour volume in mm³ corrected for tumour cellularity.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Karolinska University Hospital

Sponsor organisation

Karolinska University Hospital

Address

Eugeniavagen 3

City

Solna

Postcode

171 64

Country

Sweden

Scientific contact point

Organisation

Karolinska University Hospital

Contact name

Peter Wiklund

Public contact point

Organisation

Karolinska University Hospital

Contact name

Peter Wiklund

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications