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Study identifier: NCT07450599 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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.

Condition: High-Risk Localized Prostate Cancer  ·  Sponsor: Bayer

PhasePhase 2
Planned participants250
Who can joinMale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 trea…

This description comes directly from the study's public registry record.

Talk to the study team

Bayer Clinical Trials Contact  ·  (+)1-888-84 22937  ·  clinical-trials-contact@bayer.com

Always discuss trial participation with your own doctor first.

Locations (23)

The Second Affiliated Hospital of Anhui Medical UniversityHefei, Anhui, ChinaNot Yet Recruiting
Cancer Hospital, Chinese Academy of Medical SciencesBeijing, Beijing Municipality, ChinaRecruiting
Peking University First Hospital - Oncology DepartmentBeijing, Beijing Municipality, ChinaNot Yet Recruiting
Fujian Medical University - The First Affiliated HospitalFuzhou, Fujian, ChinaNot Yet Recruiting
Lanzhou University - The Second Hospital (The Second Clinical Medical College of Lanzhou University)Lanzhou, Gansu, ChinaNot Yet Recruiting
The first Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, Guangdong, ChinaNot Yet Recruiting
Nanfang Hospital, Southern Medical UniversityGuangzhou, Guangdong, ChinaNot Yet Recruiting
The 2nd Hospital of Hebei Medical UniversityShijiazhuang, Hebei, ChinaNot Yet Recruiting
2nd affiliated Hos. Harbin Medical UniversityHarbin, Heilongjiang, ChinaNot Yet Recruiting
Zhengzhou University - First Affiliated Hospital (Henan Medical University - First Affiliated Hospital)Zhengzhou, Henan, ChinaNot Yet Recruiting
Huazhong University of Science and Technology - Tongji Medical College - Wuhan Union HospitalWuhan, Hubei, ChinaNot Yet Recruiting
Wuhan University - Renmin Hospital (Wuhan University People's Hospital/Hubei Provincial People's Hospital)Wuhan, Hubei, ChinaNot Yet Recruiting

+ 11 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07450599