New drug combo before prostate surgery shows promise in early trial

NCT ID NCT07450599

Recruiting now Disease control Sponsor: Bayer Source: ClinicalTrials.gov ↗

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.

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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

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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