A Study Called ARAMON to Learn to What Extent Does Study Treatment With Darolutamide Affects Testosterone Levels in Men With Prostate Cancer That Had Not Been Treated With Hormonal Therapy Compared to Treatment With Enzalutamide
2期
已完成
NCT05526248
| 适应症 | Biochemically Recurrent Prostate Cancer |
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| 分期 | 2期 |
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| 申办方 | Bayer |
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| 状态 | 已完成 |
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| 受试者人数 | 28 人 |
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| 干预(药物) | Darolutamide(BAY1841788, Nubeqa), Enzalutamide |
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| 开始日期 | 2022年12月19日 |
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| 完成日期 | 2024年8月20日 |
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| 结果公布日 | 2025年10月15日 |
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摘要
Researchers are looking for a better way to treat men who have biochemically recurrent hormone-naïve prostate cancer. Hormone-naïve prostate cancer is a prostate cancer that has not yet been treated with hormonal therapy including androgen deprivation therapy (ADT). Biochemically recurrence (BCR) means that patients who received local treatment (surgery or radiation therapy) for prostate cancer now present with a rise in the blood level of a specific protein called PSA (prostate-specific antigen) but no detectable cancer or cancer spreading after a treatment that aimed to cure their prostate cancer (e.g. surgery and radiation). This may mean that the cancer has come back as the PSA level can be taken as a marker for prostate cancer development. Although men with BCR may not have symptoms for many years, proper treatment for BCR is important as the cancer may spread to other parts of the body in 7-8 years. In prostate cancer patients, male sex hormones like testosterone (also called androgens) can sometimes help the cancer spread and grow. To reduce androgen levels in these patients, androgen deprivation therapy (ADT) is often used. Second generation androgen receptor inhibitors inc
Percent Change in Serum Testosterone
From baseline to week 12 · percentage (%)
| Lead-in Phase: Darolutamide Treatment | 53.46 percentage (%) |
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