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High-Risk Localized Prostate Cancer

Bayer Identifier:
22982
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - N/A
    - 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.

Trial summary

Enrollment Goal
250
Trial Dates
April 2026 - October 2030
Phase
Phase 2
Could I Receive a placebo
No
Products
Darolutamide+ADT (BAY1841788)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Not yet recruiting
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med SchoolNanjing, 210008, China
Not yet recruiting
Shanghai Jiao Tong University School of Medicine (SJTUSM) - XinHua HospitalShanghai, 200092, China
Not yet recruiting
The Second Hospital of Anhui medical universityHefei, 230601, China
Not yet recruiting
Cancer Hospital, Chinese Academy of Medical SciencesBeijing, 100000, China
Not yet recruiting
Peking University First Hospital - Oncology DepartmentBeijing, 100034, China
Not yet recruiting
Lanzhou University - The Second Hospital (The Second Clinical Medical College of Lanzhou University)Lanzhou, 730030, China
Not yet recruiting
Dongyang People's HospitalJinhua, 322199, China
Not yet recruiting
Kunming Medical University (KMU) - Second Affiliated HospitalKunming, 650101, China
Not yet recruiting
Qilu Hosp., Shandong Univ.Jinan, N/A, China
Not yet recruiting
Nanchang University - The First Affiliated HospitalNanchang, 330006, China
Not yet recruiting
Huazhong University of Science and Technology - Tongji Medical College - Wuhan Union HospitalWuhan, 430022, China
Not yet recruiting
Fujian Medical University - The First Affiliated HospitalFuzhou, 350005, China
Not yet recruiting
Jinhua Municipal Central Hospital-Oncology DepartmentJinhua, 321000, China
Not yet recruiting
The first Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, 510230, China
Not yet recruiting
Zhengzhou University - First Affiliated Hospital (Henan Medical University - First Affiliated Hospital)Zhengzhou, 450052, China
Not yet recruiting
The Second Hospital of Tianjin Medical UniversityTianjin, 300211, China
Not yet recruiting
Shanghai General HospitalShanghai, 200080, China
Not yet recruiting
2nd affiliated Hos. Harbin Medical UniversityHarbin, 150086, China
Not yet recruiting
The 2nd Hospital of Hebei Medical UniversityShijiazhuang, 050000, China
Not yet recruiting
Nanfang Hospital, Southern Medical UniversityGuangzhou, 510515, China
Not yet recruiting
Wuhan University - Renmin Hospital (Wuhan University People's Hospital/Hubei Provincial People's Hospital)Wuhan, 430060, China
Not yet recruiting
Sichuan Cancer Hospital-Urology DepartmentChengdu, 610041, China
Not yet recruiting
China Medical University (CMU) - First Affiliated HospitalShenyang, 110001, China

Primary Outcome

  • 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.
    date_rangeTime Frame:
    Completion of Follow-up 1, 30 days after last dose of study drug

Secondary Outcome

  • 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.
    date_rangeTime Frame:
    Completion of Follow-up 1, 30 days after last dose of study drug
  • 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.
    date_rangeTime Frame:
    At baseline and at RP
  • 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.
    date_rangeTime Frame:
    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).
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    From first dose of study drug up to 30 days after the end of study drug administration

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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