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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