Condition: High-Risk Localized Prostate Cancer · Sponsor: Bayer
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.
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| The Second Affiliated Hospital of Anhui Medical University | Hefei, Anhui, China | Not Yet Recruiting |
| Cancer Hospital, Chinese Academy of Medical Sciences | Beijing, Beijing Municipality, China | Recruiting |
| Peking University First Hospital - Oncology Department | Beijing, Beijing Municipality, China | Not Yet Recruiting |
| Fujian Medical University - The First Affiliated Hospital | Fuzhou, Fujian, China | Not Yet Recruiting |
| Lanzhou University - The Second Hospital (The Second Clinical Medical College of Lanzhou University) | Lanzhou, Gansu, China | Not Yet Recruiting |
| The first Affiliated Hospital of Guangzhou Medical University | Guangzhou, Guangdong, China | Not Yet Recruiting |
| Nanfang Hospital, Southern Medical University | Guangzhou, Guangdong, China | Not Yet Recruiting |
| The 2nd Hospital of Hebei Medical University | Shijiazhuang, Hebei, China | Not Yet Recruiting |
| 2nd affiliated Hos. Harbin Medical University | Harbin, Heilongjiang, China | Not Yet Recruiting |
| Zhengzhou University - First Affiliated Hospital (Henan Medical University - First Affiliated Hospital) | Zhengzhou, Henan, China | Not Yet Recruiting |
| Huazhong University of Science and Technology - Tongji Medical College - Wuhan Union Hospital | Wuhan, Hubei, China | Not Yet Recruiting |
| Wuhan University - Renmin Hospital (Wuhan University People's Hospital/Hubei Provincial People's Hospital) | Wuhan, Hubei, China | Not Yet Recruiting |
+ 11 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07450599