Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Darolutamide · 1 trial · 1 indication
Improvement in PSMA PET metastasis free survival (ppMFS)
EPIC mean changes in sexual subdomain scores over time will be compared, both for change from baseline and absolute scores
EPIC mean changes in hormonal subdomain scores over time will be compared, both for change from baseline and absolute scores
| Arm | Type | Description |
|---|---|---|
| Phase 2 Open Label | EXPERIMENTAL | Darolutamide for up to 96 weeks (24 months) and primary SOC RT |
| Phase 3 Blinded Experimental | EXPERIMENTAL | Darolutamide + LHRHA for up to 96 weeks (24 months) and primary SOC RT |
| Phase 3 Blinded Comparator | PLACEBO_COMPARATOR | Darolutamide matched placebo + LHRHA for up to 96 weeks (24 months) and primary SOC RT |
| Name | Type | Description |
|---|---|---|
| Darolutamide | DRUG | 2x300 mg tablets twice daily, for up to 96 weeks |
| Darolutamide matched placebo | DRUG | 2x300 mg tablets twice daily, for up to 96 weeks |
| Radiotherapy | RADIATION | Preferred regimens: 60 to 62 Gy delivered in 20 fractions of 3.0 to 3.1Gy per fraction; 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction, 2-3 fractions per week |
| Zoladex 3.6Mg Implant | DRUG | 3.6 mg, subcutaneous use |
| Zoladex LA | DRUG | 10.8 mg, subcutaneous use |
| Decapeptyl sustained release 22.5 mg | DRUG | 22.5 mg, intramusculair injection |
| Decapeptyl sustained release 11.25 mg | DRUG | 11.25 mg, intramusculair injection |
| Depo-Eligard 45 mg | DRUG | 45 mg, subcutaneous use |
| Depo-Eligard 22.5 mg | DRUG | 22.5 mg, subcutaneous use |
| Depo-Eligard 7.5 mg | DRUG | 7.5 mg, subcutaneous use |
| Firmagon 120 MG Injection | DRUG | 120 mg, subcutaneous use |
| Firmagon 80 MG Injection | DRUG | 80 mg, subcutaneous use |
| Docetaxel | DRUG | 75 mg per square m, IV infusion |
Inclusion Criteria: 1. Histopathology-proven PCa 2. High-risk locally advanced disease is defined as any of the following factors: PSA \> 20 ng/mL OR T-stage 3 or 4 OR Gleason score 8-10 OR cN1. Note: documentation of the clinical T-stage may be obtained from any clinical assessment acceptable ...
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Darolutamide is an investigational small molecule being studied for the treatment of prostate cancer. It is currently in Phase 2 clinical development, evaluated in a randomized, double-blind, placebo-controlled trial for high-risk prostate cancer. The drug is not yet approved and remains under clinical investigation.
Darolutamide targets the androgen receptor (AR) and acts as an antagonist. By blocking the androgen receptor, it is designed to interfere with androgen signaling that can drive prostate cancer growth. This mechanism is being evaluated in a Phase 2 clinical trial for prostate cancer.
Darolutamide is being developed by Veracyte, Inc., a company traded on the stock exchange under the ticker VCYT. The company is conducting a Phase 2 clinical trial of darolutamide in prostate cancer, with the study currently recruiting participants in Belgium.
Darolutamide is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing Phase 2 trial is a randomized, double-blind, placebo-controlled study enrolling 493 male participants aged 18 years and older with prostate cancer.
Darolutamide is being studied in one active Phase 2 clinical trial with the identifier NCT06282588. The trial, titled 'Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers,' is recruiting participants in Belgium. The study is randomized, double-blind, and placebo-controlled, with a planned enrollment of 493 participants.