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High-risk Localized Prostate CancerPhase 2CHINANEONCT07450599

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.

A Phase 2 study testing Darolutamide and ADT in people with High-risk Localized Prostate Cancer, run by Bayer at 23 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
High-risk Localized Prostate Cancer
What is being tested?
Darolutamide and ADT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
23 sitesChina
Study dates
27 Apr 2026to 15 Oct 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • Any contraindications for RP.
  • Uncontrolled or treatment-resistant hypertension.
  • History of another malignancy within 5 years prior to randomization.

Trial locations and contacts

23 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Bayer Clinical Trials Contact contact

0018888422937

clinical-trials-contact@bayer.com

23 sites in 1 country

China23 sites, 23 recruiting

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Not yet recruiting

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610041

    Not yet recruiting

  • Dongyang People's Hospital

    Dongyang, Zhejiang, 322100

    Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

    Recruiting

  • The first Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120

    Not yet recruiting

  • Nanfang Hospital

    Guangzhou, Guangdong, 510515

    Not yet recruiting

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

    Not yet recruiting

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230601

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Recruiting

  • Jinhua Municipal Central Hospital (Affiliated Jinhua Hospital, Zhejiang University School of Medicine)

    Jinhua, Zhejiang, 321000

    Recruiting

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650101

    Not yet recruiting

  • The Second Hospital & Clinical Medical School, Lanzhou University

    Lanzhou, Gansu, 730030

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Recruiting

  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

    Recruiting

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

    Recruiting

  • Xinhua Hospital affiliated to shanghai jiao tong university school of medicine

    Shanghai, Shanghai Municipality, 200092

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Not yet recruiting

  • The 2nd Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Recruiting

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300211

    Not yet recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Not yet recruiting

Other trials in China

About this study

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

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.

Read more

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.

Being tested
Darolutamide, ADT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DarolutamideDrug

    Oral tablets of 600 mg twice daily (BID).

  • ADTDrug

    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.

Study groups in NCT07450599
Study groupRoleWhat they receive
Darolutamide + ADT (12 weeks)ExperimentalParticipants will receive darolutamide and androgen deprivation therapy (ADT) as neoadjuvant treatment for 12 weeks, followed by radical prostatectomy (RP).
Receives: Drug: Darolutamide; Drug: ADT
Darolutamide + ADT (24 weeks)ExperimentalParticipants will receive darolutamide and androgen deprivation therapy (ADT) as neoadjuvant treatment for 24 weeks, followed by radical prostatectomy (RP).
Receives: Drug: Darolutamide; Drug: ADT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (6)

  1. 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.

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

  2. 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.

    Measured: At baseline and immediately after radical prostatectomy

  3. 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.

    Measured: Immediately after radical prostatectomy

  4. 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).

    Measured: 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

  5. 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.

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

  6. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2026
  2. Study start27 Apr 2026
  3. Primary completion15 Oct 2028 (estimated)
  4. Study completion15 Oct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07450599
Sponsor's protocol ID
22982
Acronym
CHINANEO
Status last verified
10 Oct 2026
First submitted
12 Feb 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Darolutamide and ADT in people with High-risk Localized Prostate Cancer, run by Bayer at 23 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bayer Clinical Trials Contact (0018888422937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of participants achieving pathologic response rate (pRR: pathologic complete response [pCR] or minimal residual disease [MRD]) (time frame: Completion of Follow-up 1, 30 days after last dose of study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07450599.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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