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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Second Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting
• Cancer Hospital, Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting
• The First Affiliated Hospital of Fujian Medical University
  Fuzhou, Fujian, China Recruiting
• The Second Hospital & Clinical Medical School, Lanzhou University
  Lanzhou, Gansu, China Recruiting
• The first Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting
• Nanfang Hospital
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: 0018888422937

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.