Darolutamide for Prostate adenocarcinoma (high-risk localized or locally advanced)

Inclusion criteria

• {"criterion_text":"- Patients must be >= 18 years of age"}
• {"criterion_text":"- A clinically relevant Prostate MRI"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Candidate for radical prostatectomy"}
• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1"}
• {"criterion_text":"- Able to receive Darolutamide for 90-120 days"}
• {"criterion_text":"- Signed informed consent form"}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- 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

• {"criterion_text":"- ≥M1 or ≥N2"}
• {"criterion_text":"- Prior treatment with androgen receptor antagonists"}
• {"criterion_text":"- Treatment with gonadotropin-releasing hormone (GnRH)"}
• {"criterion_text":"- History of prior systemic or local therapy for prostate cancer, including pelvic radiation to the prostate"}
• {"criterion_text":"- Major surgery <=4 weeks prior to inclusion"}

Primary endpoints

• {"endpoint_text":"- Association of pathological response (MRD) with the pre-treatment genomic biomarker PCAI ImmunoScore","definition_or_measurement_approach":"Association between pathological response (minimal residual disease, MRD) assessed on surgical pathology specimens after neoadjuvant Darolutamide and the pre-treatment genomic biomarker PCAI ImmunoScore."}

Secondary endpoints

• {"endpoint_text":"- The associaton of the PCAI ImmunoScore with pathologic complete response (pCR)","definition_or_measurement_approach":"Correlation between PCAI ImmunoScore and pathological complete response as determined on final pathology."}
• {"endpoint_text":"- The associaton of the PCAI ImmunoScore with pT-stage at final pathology","definition_or_measurement_approach":"Association between PCAI ImmunoScore and pathological T-stage at final pathology."}
• {"endpoint_text":"- The associaton of the PCAI ImmunoScore with size of largest cross-sectional dimension of residual tumour on pathology","definition_or_measurement_approach":"Correlation between PCAI ImmunoScore and the largest cross-sectional tumour dimension measured on pathology."}
• {"endpoint_text":"- The associaton of the PCAI ImmunoScore with number of resection specimen slides in which the tumour can be seen on pathology","definition_or_measurement_approach":"Association between PCAI ImmunoScore and the number of histology slides showing tumour in the resection specimen."}
• {"endpoint_text":"- The associaton of the PCAI ImmunoScore with MRI assessment of changes in tumour size, cross sectional dimension, volume, and EPE","definition_or_measurement_approach":"Correlation between PCAI ImmunoScore and MRI-assessed changes in tumour size, cross-sectional dimension, tumour volume, and extracapsular extension (EPE)."}
• {"endpoint_text":"- The associaton of the PCAI ImmunoScore with blood PSA concentration during treatment","definition_or_measurement_approach":"Association between PCAI ImmunoScore and serial blood PSA concentrations measured during treatment."}
• {"endpoint_text":"- Correlation between Pathological response and MRI response.","definition_or_measurement_approach":"Comparison/correlation of pathological response endpoints with MRI response assessments."}
• {"endpoint_text":"- Hormonal side effects during and after treatment, measured through AE/SAE registration and repeated validated questionnaires as well as changes in blood testosterone concentration","definition_or_measurement_approach":"Hormonal side effects captured via adverse event/serious adverse event reporting, repeated validated questionnaires, and serial blood testosterone measurements."}
• {"endpoint_text":"- Post- surgical functional outcomes (erectile function and urinary continence) in the cohort measured through questionnaires","definition_or_measurement_approach":"Post-surgical functional outcomes assessed by patient questionnaires addressing erectile function and urinary continence."}
• {"endpoint_text":"- The association of the PCAI ImmunoScore with Residual Cancer Burden (RCB), defined as residual tumour volume in mm³ corrected for tumour cellularity.","definition_or_measurement_approach":"Association between PCAI ImmunoScore and Residual Cancer Burden (RCB), where RCB is defined as residual tumour volume in mm³ corrected for tumour cellularity."}

Sweden

Earliest CTIS Part Ii Submission Date

03-04-2025

Latest Decision Or Authorization Date

16-04-2026

Processing Time Days

378

Number Of Sites

2

Number Of Participants

100

Primary sponsor

Full Name

Karolinska University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden

Third parties

• {"country":"","full_name":"Bayer AB","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"Philips Electronics","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"European Union","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"OHMX.Bio","duties_or_roles":"Source of monetary support","organisation_type":""}