Approval Probability
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Darolutamide twice daily · 2 trials · 2 indications
Radiographic progression-free survival (rPFS) is defined as the time from randomization to radiographic disease progression or death from any cause, whichever occurs first. Progression is assessed using RECIST 1.1 for soft tissue and PCWG3 criteria for bone lesions. The 3-year rPFS rate will be estimated using the Kaplan-Meier method.
PSA response rate of ≥50% decline is defined as the proportion of participants who have achieved a decline of 50% or more from baseline during treatment at any time.
| Arm | Type | Description |
|---|---|---|
| PSMA PET/CT-Guided SBRT + Darolutamide + ADT | EXPERIMENTAL | After a 6-month run-in period of darolutamide plus androgen deprivation therapy, eligible participants without disease progression and with residual PSMA PET/CT-positive active tumor lesions will receive PSMA PET/CT-guided stereotactic body radiotherapy to all active tumor lesions while continuing darolutamide plus androgen deprivation therapy. |
| Darolutamide + ADT | ACTIVE_COMPARATOR | After a 6-month run-in period of darolutamide plus androgen deprivation therapy, eligible participants without disease progression and with residual PSMA PET/CT-positive active tumor lesions will continue darolutamide plus androgen deprivation therapy without local radiotherapy. |
| Darolutamide in addition to Androgen deprivation therapy | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) | RADIATION | Stereotactic body radiotherapy will be delivered in the experimental arm after the 6-month run-in period of darolutamide plus androgen deprivation therapy. Radiotherapy will target all residual PSMA PET/CT-positive active tumor lesions, while participants continue darolutamide plus androgen deprivation therapy. Target lesions may include active lesions in the prostate or prostate bed and metastatic sites. Dose and fractionation will be selected according to lesion location, lesion size, and organ-at-risk constraints as specified in the study protocol. |
| Darolutamide 600 mg twice daily | DRUG | Darolutamide will be administered orally at 600 mg twice daily with food during the 6-month run-in period in combination with androgen deprivation therapy. After randomization, darolutamide will be continued in both treatment groups according to the assigned treatment strategy. Treatment may be interrupted or dose-reduced according to protocol-defined toxicity management rules. |
| Androgen Deprivation Therapy (ADT) | DRUG | Androgen deprivation therapy will be maintained throughout study treatment in both groups. The method of androgen deprivation therapy will be selected by the investigator according to the participant's clinical condition and may include surgical castration or medical castration with a luteinizing hormone-releasing hormone agonist or antagonist. Treatment will aim to maintain castrate testosterone levels according to the study protocol. |
Inclusion Criteria: * Male participants aged ≥18 years and \<85 years. * Histologically confirmed prostate adenocarcinoma. * No neuroendocrine carcinoma, ductal adenocarcinoma, small-cell carcinoma, signet-ring cell carcinoma, or sarcomatoid carcinoma component. * Metastatic prostate cancer confirm...
Darolutamide twice daily is an investigational small molecule being studied for prostate cancer, including metastatic hormone-sensitive prostate cancer (mHSPC). It is taken as a 600 mg dose twice daily and is currently in Phase 2 clinical development.
Darolutamide twice daily is being developed by Bayer AG, which trades under the ticker BAYRY. The company is conducting Phase 2 clinical trials to evaluate the drug in prostate cancer indications.
Darolutamide twice daily is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials are listed, one completed and one not yet recruiting.
Darolutamide twice daily is being studied in two Phase 2 trials. NCT05171387, completed, enrolled 78 men with high-risk nonmetastatic prostate cancer in China. NCT07649421, not yet recruiting, plans to enroll 254 men with mHSPC in China, combining PSMA PET/CT-guided SBRT with darolutamide.
Yes, Darolutamide twice daily is the same as Darolutamide 600 mg twice daily. The drug is administered at a dose of 600 mg twice daily, and both names refer to the same investigational treatment.
Darolutamide twice daily is a small molecule that targets the androgen receptor, a key driver in prostate cancer growth. By blocking this receptor, it aims to inhibit cancer cell proliferation. It is being studied in combination with androgen deprivation therapy in clinical trials.