New drug combo before prostate surgery shows promise in early trial

NCT ID NCT07450599

First seen Jun 27, 2026 · Last updated Jun 27, 2026

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • 2nd affiliated Hos. Harbin Medical University

    NOT_YET_RECRUITING

    Harbin, Heilongjiang, 150086, China

  • Cancer Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100000, China

  • China Medical University (CMU) - First Affiliated Hospital

    NOT_YET_RECRUITING

    Shenyang, Liaoning, 110001, China

  • Dongyang People's Hospital

    NOT_YET_RECRUITING

    Jinhua, Zhejiang, 322199, China

  • Fujian Medical University - The First Affiliated Hospital

    NOT_YET_RECRUITING

    Fuzhou, Fujian, 350005, China

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

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430022, China

  • Jinhua Municipal Central Hospital-Oncology Department

    NOT_YET_RECRUITING

    Jinhua, Zhejiang, 321000, China

  • Kunming Medical University (KMU) - Second Affiliated Hospital

    NOT_YET_RECRUITING

    Kunming, Yunnan, 650101, China

  • Lanzhou University - The Second Hospital (The Second Clinical Medical College of Lanzhou University)

    NOT_YET_RECRUITING

    Lanzhou, Gansu, 730030, China

  • NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School

    RECRUITING

    Nanjing, Jiangsu, 210008, China

  • Nanchang University - The First Affiliated Hospital

    NOT_YET_RECRUITING

    Nanchang, Jiangxi, 330006, China

  • Nanfang Hospital, Southern Medical University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510515, China

  • Peking University First Hospital - Oncology Department

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 100034, China

  • Qilu Hosp., Shandong Univ.

    NOT_YET_RECRUITING

    Jinan, Shandong, 250012, China

  • Shanghai General Hospital

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200080, China

  • Shanghai Jiao Tong University School of Medicine (SJTUSM) - XinHua Hospital

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200092, China

  • Sichuan Cancer Hospital-Urology Department

    NOT_YET_RECRUITING

    Chengdu, Sichuan, 610041, China

  • The 2nd Hospital of Hebei Medical University

    NOT_YET_RECRUITING

    Shijiazhuang, Hebei, 050000, China

  • The Second Affiliated Hospital of Anhui Medical University

    NOT_YET_RECRUITING

    Hefei, Anhui, 230601, China

  • The Second Hospital of Tianjin Medical University

    NOT_YET_RECRUITING

    Tianjin, Tianjin Municipality, 300211, China

  • The first Affiliated Hospital of Guangzhou Medical University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510230, China

  • Wuhan University - Renmin Hospital (Wuhan University People's Hospital/Hubei Provincial People's Hospital)

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430060, China

  • Zhengzhou University - First Affiliated Hospital (Henan Medical University - First Affiliated Hospital)

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 450052, China