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.

NCT07450599
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
250
clinicaltrials.gov
Lead sponsor
Bayer
clinicaltrials.gov
Start date
2026-04-27
clinicaltrials.gov
Number of sites
23
clinicaltrials.gov

Summary
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 2years 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.
clinicaltrials.gov
Acronym
CHINANEO
clinicaltrials.gov
Short title
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.
clinicaltrials.gov
Official title
A China Interventional Phase II, Single Arm, Multicenter Study Evaluating the Effectiveness and Safety of Darolutamide + ADT as Neo-Adjuvant Treatment in Treatment-naïve Patients Who Have Planned for Radical Prostatectomy (RP) With High Risk Localized Prostate Cancer
clinicaltrials.gov

Control arm
Open label
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2030-10-15
clinicaltrials.gov
First posted
2026-03-04
clinicaltrials.gov
Registry last updated
2026-10-13
clinicaltrials.gov
Primary completion date
2028-10-15
clinicaltrials.gov
Start date
2026-04-27
clinicaltrials.gov

Participants
250
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
250
clinicaltrials.gov
Protocol amendments
2
clinicaltrials.gov
Number of sites
23
clinicaltrials.gov

Data monitoring committee
No
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Bayer
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07450599
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07450599
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. The proportion of participants achieving pathologic response rate (pRR: pathologic complete response [pCR] or minimal residual disease [MRD])

    Timeframe: Completion of Follow-up 1, 30 days after last dose of study drug

    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.

  1. Proportion of participants with pathologic complete response (pCR)

    Timeframe: Completion of Follow-up 1, 30 days after last dose of study drug

    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.

  2. Percentage of participants with tumor downstaging (e.g. clinical T3 to pathologic T2)

    Timeframe: At baseline and immediately after radical prostatectomy

    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.

  3. Percentage of participants with positive surgical margin (PSM)

    Timeframe: Immediately after radical prostatectomy

    PSM is defined as the presence of cancer cells at the edge of the tissue removed during surgery.

  4. Biochemical complete response (CR) rate prior to radical prostatectomy (RP) and at landmark timepoints post-RP

    Timeframe: 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 CR rate is defined as participants who attain serum prostate-specific antigen (PSA) level below 0.1 ng/mL (PSA \<0.1 ng/mL).

  5. Biochemical recurrent free survival since radical prostatectomy (RP) among participants with prostate-specific antigen (PSA) <0.1 ng/mL after RP

    Timeframe: From RP to biochemical recurrence or death whichever occurs first, up to 2.5 years

    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.

  6. Incidence and severity of treatment-emergent adverse events (TEAEs) (including treatment-emergent serious adverse events [TESAEs])

    Timeframe: From first dose of study drug up to 30 days after the end of study drug administration

    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.

Sources for outcomes
clinicaltrials.gov

Sex
Male
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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.

Sources for eligibility
clinicaltrials.gov

  • The Second Affiliated Hospital of Anhui Medical UniversityHefei, ChinaRecruiting
  • Cancer Hospital, Chinese Academy of Medical SciencesBeijing, ChinaRecruiting
  • Peking University First HospitalBeijing, ChinaNot yet recruiting
  • The First Affiliated Hospital of Fujian Medical UniversityFuzhou, ChinaRecruiting
  • The Second Hospital & Clinical Medical School, Lanzhou UniversityLanzhou, ChinaRecruiting
  • The first Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaNot yet recruiting
  • Nanfang HospitalGuangzhou, ChinaNot yet recruiting
  • The 2nd Hospital of Hebei Medical UniversityShijiazhuang, ChinaRecruiting
  • The 2nd Affiliated Hospital of Harbin Medical UniversityHarbin, ChinaNot yet recruiting
  • The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaNot yet recruiting
  • Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaRecruiting
  • Renmin Hospital of Wuhan UniversityWuhan, ChinaRecruiting
  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical SchoolNanjing, ChinaRecruiting
  • The First Affiliated Hospital of Nanchang UniversityNanchang, ChinaRecruiting
  • The First Hospital of China Medical UniversityShenyang, ChinaNot yet recruiting
  • Qilu Hospital of Shandong UniversityJinan, ChinaRecruiting
  • Shanghai General HospitalShanghai, ChinaRecruiting
  • Xinhua Hospital affiliated to shanghai jiao tong university school of medicineShanghai, ChinaRecruiting
  • Sichuan Cancer HospitalChengdu, ChinaNot yet recruiting
  • The Second Hospital of Tianjin Medical UniversityTianjin, ChinaNot yet recruiting
  • The Second Affiliated Hospital of Kunming Medical UniversityKunming, ChinaNot yet recruiting
  • Dongyang People's HospitalDongyang, ChinaRecruiting
  • Jinhua Municipal Central Hospital (Affiliated Jinhua Hospital, Zhejiang University School of Medicine)Jinhua, ChinaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Targets (2)