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New drug combo before prostate surgery shows promise in early trial

NCT ID NCT07450599

Disease control Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times

Summary

This study tests whether taking darolutamide (a hormone-blocking pill) plus standard hormone therapy for 12 or 24 weeks before prostate removal surgery can reduce or eliminate cancer in men with high-risk localized prostate cancer. About 250 men in China will be randomly assigned to one of two treatment durations. The main goal is to see how many men have no cancer or only minimal cancer left in the removed prostate. Participants will be followed for up to 2 years after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Darolutamide (oral tablets) plus goserelin acetate implant (ADT)
What this could lead to
If successful, this could show that a shorter or longer course of darolutamide plus ADT before surgery improves cancer clearance, potentially leading to better outcomes for men with high-risk localized prostate cancer.
What could go wrong
This is an early Phase 2 study with only 250 participants, so results may not apply to all patients. The treatment may cause side effects, and it's not yet known if it improves long-term survival or just pathological response.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

High risk localized prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    23 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cancer Hospital Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100021, China

  • Dongyang People's Hospital

    NOT_YET_RECRUITING

    Dongyang, Zhejiang, 322100, China

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

    NOT_YET_RECRUITING

    Jinhua, Zhejiang, 321000, China

  • Nanfang Hospital

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510515, China

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

    RECRUITING

    Nanjing, Jiangsu, 210008, China

  • Peking University First Hospital

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 100034, China

  • Qilu Hospital of Shandong University

    NOT_YET_RECRUITING

    Jinan, Shandong, 250012, China

  • Renmin Hospital of Wuhan University

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430060, China

  • Shanghai General Hospital

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200080, China

  • Sichuan Cancer Hospital

    NOT_YET_RECRUITING

    Chengdu, Sichuan, 610041, China

  • The 2nd Affiliated Hospital of Harbin Medical University

    NOT_YET_RECRUITING

    Harbin, Heilongjiang, 150001, China

  • The First Affiliated Hospital of Fujian Medical University

    NOT_YET_RECRUITING

    Fuzhou, Fujian, 350005, China

  • The First Affiliated Hospital of Guangzhou Medical University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510120, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Zhengzhou University

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 450052, China

  • The First Hospital of China Medical University

    NOT_YET_RECRUITING

    Shenyang, Liaoning, 110001, China

  • The Second Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230601, China

  • The Second Affiliated Hospital of Kunming Medical University

    NOT_YET_RECRUITING

    Kunming, Yunnan, 650101, China

  • The Second Hospital & Clinical Medical School, Lanzhou University

    NOT_YET_RECRUITING

    Lanzhou, Gansu, 730030, China

  • The Second Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, 050000, China

  • The Second Hospital of Tianjin Medical University

    NOT_YET_RECRUITING

    Tianjin, Tianjin Municipality, 300211, China

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

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430022, China

  • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200092, China

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