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Peri-operative darolutamide+ surgery · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Control arm | ACTIVE_COMPARATOR | - |
| Experimental arm | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Surgery alone | OTHER | Radical prostatectomy with lymph node dissection will be performed. |
| Peri-operative darolutamide + surgery. | DRUG | Darolutamide: 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg; for a total duration of 9 months. Darolutamide will start at day 1. Surgery: radical prostatectomy with lymph node dissection will be performed after at least 3 months of darolutamide treatment. |
Inclusion Criteria: 1. Age ≥18 years 2. Histologically confirmed adenocarcinoma of the prostate 3. High-risk and/or locally advanced prostate cancer diagnosis defined by: One of the following criteria is sufficient to define a high-risk and/or locally advanced prostate cancer: * ISUP grade 4...
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Peri-operative darolutamide + surgery is an investigational treatment being studied for prostate cancer. It combines the small molecule darolutamide with surgical intervention in the peri-operative setting, meaning before and/or after surgery. The approach is being evaluated in high-risk and/or locally advanced prostate cancer patients.
Darolutamide is an androgen receptor inhibitor, a type of small molecule that blocks the effects of androgens on prostate cancer cells. By inhibiting the androgen receptor, darolutamide aims to slow or stop cancer growth. In this regimen, it is given around the time of surgery to potentially improve outcomes.
Peri-operative darolutamide + surgery is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded under the ticker symbol BAYRY on the OTC market. The company is conducting clinical research to evaluate this combination approach in prostate cancer.
Peri-operative darolutamide + surgery is currently in Phase 2 clinical development. It is an investigational regimen, meaning it has not been approved by regulatory authorities. The ongoing Phase 2 trial is actively enrolling participants, though recruitment is not yet complete.
Peri-operative darolutamide + surgery is being studied in a single active Phase 2 trial with the identifier NCT05826509. The trial, titled 'SUrGery With or Without dARolutamide in High-risk and/or Locally Advanced Prostate Cancer,' is being conducted in France and aims to enroll 240 male participants aged 18 years and older.
Yes, Peri-operative darolutamide + surgery is the same as Peri-operative darolutamide + surgery. The name refers to the same investigational regimen combining darolutamide with surgery in the peri-operative period for prostate cancer. No alternative names have been established for this treatment approach.