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Darolutamide plus hormone therapy before prostate removal for men with high-risk localized prostate cancer

CHINANEO: A China Phase 2, Open-Label, Randomized, Multicenter Study to Investigate the Efficacy and Safety of Darolutamide + ADT as Neo-Adjuvant Treatment for 12 Weeks vs 24 Weeks in Treatment-Naïve Participants Who Have Planned for Radical Prostatectomy (RP) With High-Risk Localized Prostate Cancer

Phase 2 Interventional Bayer · NCT07450599

This study tests whether adding darolutamide to standard hormone (androgen-deprivation) therapy for 12 or 24 weeks before prostate removal helps men with high-risk localized prostate cancer.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years and up
SexMale
SponsorBayer Industry-sponsored
Locations23 sites (Hefei, Anhui and 22 other locations)
Trial IDNCT07450599 on ClinicalTrials.gov

What this trial studies

Men with high-risk localized prostate cancer who plan radical prostatectomy will receive darolutamide in combination with androgen-deprivation therapy before surgery. Participants are assigned to receive the combination for either 12 weeks or 24 weeks so researchers can compare cancer response between the two durations. After neoadjuvant treatment, patients undergo radical prostatectomy with pelvic lymph node dissection and tissue and imaging findings will be used to judge tumor response. The study compares the percentage of patients with favorable pathological changes and other prespecified outcomes between the two treatment durations.

Who should consider this trial

Good fit: Men aged 18 or older with darolutamide‑naïve, high‑risk localized prostate adenocarcinoma per NCCN criteria, no distant metastases on recent imaging, and who are candidates for radical prostatectomy with pelvic lymph node dissection are ideal candidates.

Not a fit: Men with metastatic disease, those not planning prostatectomy, or those who have already received darolutamide are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination could shrink tumors before surgery and lower the chance of residual disease or early recurrence.

How similar studies have performed: Similar neoadjuvant approaches combining ADT with androgen‑receptor blockers have produced promising tumor shrinkage and pathologic responses in early trials, but long‑term survival benefits remain unproven.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participants must be 18 years or older at the time of signing the informed consent.
* Darolutamide-naïve participants who are with localized prostate adenocarcinoma who plan to receive radical prostatectomy (RP) and defined as high risk with National Comprehensive Cancer Network (NCCN) criteria (version 1.2025).
* No evidence of distant metastasis based on computed tomography (CT), magnetic resonance imaging (MRI), and whole body bone scan (WBBS) within 42 days prior to start of study treatment.
* Candidate for RP with pelvic lymph node dissection (PLND) or extended PLND (ePLND) as per the investigator.
* Participants must have at least one of the following features according to NCCN definition of high-risk:

  * Biopsy Gleason score ≥8, and/or
  * Prostate-specific antigen (PSA) \>20 ng/mL measured during Screening and prior to randomization, or
  * Clinical stage ≥ T3a.
* Participants with pelvic lymph node involvement (N1) can be included.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Exclusion Criteria:

* Prostate cancer with known neuroendocrine (NE) differentiation or small cell features.
* Evidence of metastatic disease. Minimum imaging requirements to exclude metastatic disease are diagnostic quality imaging of the chest, pelvis, and the abdomen (CT or MRI with intravenous \[IV\] contrast), and WBBS. Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion.
* Intolerant to darolutamide or androgen deprivation therapy (ADT) treatment.
* History of

  * Loss of consciousness or transient ischemic attack or stroke within 6 months prior to randomization, or
  * Significant cardiovascular disease within 6 months prior to randomization.
  * Any contraindications for RP.
* Uncontrolled or treatment-resistant hypertension.
* History of another malignancy within 5 years prior to randomization.

Where this trial is running

Hefei, Anhui and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions High-Risk Localized Prostate Cancer
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.