A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer. (CHINANEO)

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

Researchers are looking for a better way to treat men who have high-risk localized prostate cancer, which refers to a type of prostate cancer that is still confined to the prostate gland but has certain characteristics that make it more likely to grow and spread.

The study treatment darolutamide plus androgen deprivation therapy (ADT) is under development as treatment before surgery for men who have high-risk localized prostate cancer. Darolutamide works by blocking the attachment of androgen hormones to androgen receptors in cancer cells, thereby blocking cancer progression and growth. ADT is an established treatment that is used to lower the amount of androgen hormones (e.g., testosterone) in the body.

The main purpose of this study is to learn how the cancer responds to the two different treatment durations (12 weeks or 24 weeks) of darolutamide combined with ADT used before the men undergo surgery to remove the prostate. For this, the researchers will compare the percentage of participants who either achieve complete response to the treatment (where no cancer cells are found) or with condition of minimal residual disease after the treatment (where only a small amount of cancer cells remains).

The study participants will be randomly (by chance) assigned to one of two treatment groups. Depending on the group, they will receive darolutamide tablets by mouth plus ADT administered under the skin for either 12 weeks or 24 weeks. No more than 30 days after the end of the treatments, study participants will be performed with surgery to remove the prostate.

Each participant will be in the study for approximately 29 to 32 months, including a screening phase of up to 28 days, 12 weeks or 24 weeks of treatment depending on the treatment groups, followed by the surgery no more than 30 days after the treatment, and a follow up phase of up to 2 years after the surgery.

2 visits to the study site are planned during the screening phase, followed by 3 to 6 visits (every 28 days) during treatment. The treatment period ends with a visit within 7 days after the last dose of treatment.

During the study, the doctors and their study team will:

• take blood and urine samples
• check the participants' health parameters
• do physical examinations
• check if the participants' cancer has grown and/or spread using CT (computed tomography) or MRI (magnetic resonance imaging) and, if needed, bone scan
• take tumor samples
• ask the participants questions about how they are feeling and what adverse events they are having.

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

About 30 days after the last dose of treatment, 5 weeks after the surgery and every 12 weeks thereafter, the study doctors and their team will check the participants' health and any changes in cancer. This follow-up period ends 2 years after the surgery.

Study Overview

• Status: Recruiting
• Conditions: High-Risk Localized Prostate Cancer
• Intervention / Treatment: Drug: Darolutamide; Drug: ADT

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• China
  • Beijing, China, 100000
    • Recruiting
    • Cancer Hospital, Chinese Academy of Medical Sciences
  • Beijing, China, 100034
    • Not yet recruiting
    • Peking University First Hospital - Oncology Department
  • Chengdu, China, 610041
    • Not yet recruiting
    • Sichuan Cancer Hospital-Urology Department
  • Fuzhou, China, 350005
    • Not yet recruiting
    • Fujian Medical University - The First Affiliated Hospital
  • Guangzhou, China, 510230
    • Not yet recruiting
    • The First Affiliated Hospital of Guangzhou Medical University
  • Lanzhou, China, 730030
    • Not yet recruiting
    • Lanzhou University - The Second Hospital (The Second Clinical Medical College of Lanzhou University)
  • Nanchang, China, 330006
    • Not yet recruiting
    • Nanchang University - The First Affiliated Hospital
  • Shanghai, China, 200080
    • Not yet recruiting
    • Shanghai General Hospital
  • Shanghai, China, 200092
    • Not yet recruiting
    • Shanghai Jiao Tong University School of Medicine (SJTUSM) - XinHua Hospital
  • Shenyang, China, 110001
    • Not yet recruiting
    • China Medical University (CMU) - First Affiliated Hospital
  • Tianjin, China, 300211
    • Not yet recruiting
    • The Second Hospital of Tianjin Medical University
  • Wuhan, China, 430022
    • Not yet recruiting
    • Huazhong University of Science and Technology - Tongji Medical College - Wuhan Union Hospital
  • Wuhan, China, 430060
    • Not yet recruiting
    • Wuhan University - Renmin Hospital (Wuhan University People's Hospital/Hubei Provincial People's Hospital)
  • Zhengzhou, China, 450052
    • Not yet recruiting
    • Zhengzhou University - First Affiliated Hospital (Henan Medical University - First Affiliated Hospital)
  • Anhui
    • Hefei, Anhui, China, 230601
      • Not yet recruiting
      • The Second Affiliated Hospital of Anhui Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Not yet recruiting
      • Nanfang Hospital, Southern Medical University
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Not yet recruiting
      • The 2nd Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150086
      • Not yet recruiting
      • 2nd affiliated Hos. Harbin Medical University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Not yet recruiting
      • NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
  • Shandong
    • Jinan, Shandong, China, 250012
      • Not yet recruiting
      • Qilu Hosp., Shandong Univ.
  • Yunnan
    • Kunming, Yunnan, China, 650101
      • Not yet recruiting
      • Kunming Medical University (KMU) - Second Affiliated Hospital
  • Zhejiang
    • Jinhua, Zhejiang, China, 322199
      • Not yet recruiting
      • Dongyang People's Hospital
    • Jinhua, Zhejiang, China, 321000
      • Not yet recruiting
      • Jinhua Municipal Central Hospital-Oncology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Darolutamide + ADT (12 weeks); Participants will receive darolutamide and androgen deprivation therapy (ADT) as neoadjuvant treatment for 12 weeks, followed by radical prostatectomy (RP).	Drug: Darolutamide; Oral tablets of 600 mg twice daily (BID).; Drug: ADT; Goserelin acetate implant (ZOLADEX), at a dose of 10.8 mg, will be administered subcutaneously every 12 weeks into the anterior abdominal wall below the navel line.
Experimental: Darolutamide + ADT (24 weeks); Participants will receive darolutamide and androgen deprivation therapy (ADT) as neoadjuvant treatment for 24 weeks, followed by radical prostatectomy (RP).	Drug: Darolutamide; Oral tablets of 600 mg twice daily (BID).; Drug: ADT; Goserelin acetate implant (ZOLADEX), at a dose of 10.8 mg, will be administered subcutaneously every 12 weeks into the anterior abdominal wall below the navel line.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of participants achieving pathologic response rate (pRR: pathologic complete response [pCR] or minimal residual disease [MRD])	pRR is defined as the proportion of participants with either condition of pCR or MRD at week 12 or 24 in corresponding arm. Proportion of participants with pCR is defined as the proportion of participants with no residual tumor detected in radical prostatectomy (RP) specimens following 12 or 24 weeks of neoadjuvant treatment of darolutamide and ADT per randomization. Proportion of participants with MRD is defined as the proportion of participants that have residual cancer burden (RCB) ≤0.25 cm^3 in the RP specimens.	Completion of Follow-up 1, 30 days after last dose of study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with pathologic complete response (pCR)	Proportion of participants with pCR is defined as the proportion of participants with no residual tumor detected in radical prostatectomy (RP) specimens following 12 or 24 weeks of neoadjuvant treatment of darolutamide and ADT per randomization.	Completion of Follow-up 1, 30 days after last dose of study drug
Percentage of participants with positive surgical margin (PSM)	PSM is defined as the presence of cancer cells at the edge of the tissue removed during surgery.	Immediately after radical prostatectomy
Biochemical complete response (CR) rate prior to radical prostatectomy (RP) and at landmark timepoints post-RP	Biochemical CR rate is defined as participants who attain serum prostate-specific antigen (PSA) level below 0.1 ng/mL (PSA <0.1 ng/mL).	At pre-RP, at 5 weeks, 12 weeks post-RP, and every 3 months after that until Year 2 after RP or end of follow up
Biochemical recurrent free survival since radical prostatectomy (RP) among participants with prostate-specific antigen (PSA) <0.1 ng/mL after RP	Biochemical recurrent free survival is defined as time from RP to biochemical recurrence or death, whichever occurs first. The endpoint will be assessed only among participants with PSA <0.1 ng/mL after RP. Biochemical recurrence is defined as PSA ≥0.1 ng/mL in 2 consecutive measurements after RP. The date of the first measurement defines the date of biochemical recurrence.	From RP to biochemical recurrence or death whichever occurs first, up to 2.5 years
Incidence and severity of treatment-emergent adverse events (TEAEs) (including treatment-emergent serious adverse events [TESAEs])	TEAEs are defined as AEs with an onset date on or after the first dose of study drug and up to the end-of-study drug plus 30 days or with an onset date prior to the first dose of study drug but worsening in intensity after the study drug. Events with missing onset dates will be included as treatment-emergent.	From first dose of study drug up to 30 days after the end of study drug administration
Percentage of participants with tumor downstaging (e.g. clinical T3 to pathologic T2)	The pathology review will compare the T stage of tumor tissue at baseline (Screening) with the T stage of radical prostatectomy (RP) specimen at RP and calculate the proportion of participants whose tumor stage has decreased from the baseline T stage.	At baseline and immediately after radical prostatectomy

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): October 15, 2030

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: darolutamide
• Other Study ID Numbers: 22982

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access.

As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No