NCT07617272 Prostate Androgen Response Investigation Using a Stratification BIOmarker; Predicting Prostate Cancer Downstaging by Neoadjuvant Darolutamide With PCAI ImmunoScore
| NCT ID | NCT07617272 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Region Stockholm |
| Condition | Prostate Cancer (Adenocarcinoma) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-11-09 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2025-11-09 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Peter N Wiklund, MD, Professor
PRINCIPAL INVESTIGATOR
Region Stockholm represented by Karolinska University Hospital
Frequently Asked Questions
Who can join the NCT07617272 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer (Adenocarcinoma). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07617272 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07617272 currently recruiting?
Yes, NCT07617272 is actively recruiting participants. Contact the research team at per.vincent@regionstockholm.se for enrollment information.
Where is the NCT07617272 trial being conducted?
This trial is being conducted at Gothenburg, Sweden, Stockholm, Sweden.
Who is sponsoring the NCT07617272 clinical trial?
NCT07617272 is sponsored by Region Stockholm. The principal investigator is Peter N Wiklund, MD, Professor at Region Stockholm represented by Karolinska University Hospital. The trial plans to enroll 100 participants.
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