Hormone Naive Prostate Cancer
Conditions
Brief summary
The primary endpoint is the PSA response assessed at 24 weeks. PSA response is defined as a ≥ 80% decline in PSA measurement taken at week 24 relative to the measurement taken at baseline, in the darolutamide study arm. The ADT arm is used as an internal control.
Detailed description
The main key secondary endpoint in this study is the change in hormone-treatment related symptoms scale of the EORTC QLQ-PR25 at 24 weeks compared to baseline in the darolutamide study arm. A 10-point difference is regarded as a clinically meaningful benefit., Safety according to NCI-CTC version 4.0, Objective response rate at 24 weeks in patients with RECIST 1.1 measurable disease at baseline, PSA complete response rate at 24 weeks defined as a ≥ 90% decline in PSA measurement at week 24 relative to the measurement taken at baseline
Interventions
Sponsors
European Organisation For Research And Treatment Of Cancer
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the PSA response assessed at 24 weeks. PSA response is defined as a ≥ 80% decline in PSA measurement taken at week 24 relative to the measurement taken at baseline, in the darolutamide study arm. The ADT arm is used as an internal control. | — |
Secondary
| Measure | Time frame |
|---|---|
| The main key secondary endpoint in this study is the change in hormone-treatment related symptoms scale of the EORTC QLQ-PR25 at 24 weeks compared to baseline in the darolutamide study arm. A 10-point difference is regarded as a clinically meaningful benefit., Safety according to NCI-CTC version 4.0, Objective response rate at 24 weeks in patients with RECIST 1.1 measurable disease at baseline, PSA complete response rate at 24 weeks defined as a ≥ 90% decline in PSA measurement at week 24 relative to the measurement taken at baseline | — |
Countries
Belgium, France, Italy, Spain
Outcome results
None listed