RAndomized, open label, multicenter study of Docetaxel versus an Androgen Receptor-targeted agent (abiraterone orenzalutamide) as first-line of therapy in mCRPC patients with adverse prognostic factors (RADAR-1 CRPC)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518623-30-00

Acronym

RADAR-1 CRPC

Enrollment

Registered

2024-11-26

Start date

2020-10-01

Completion date

Unknown

Last updated

2024-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic castration resistant prostate cancer without mutations of BRCA1/2 genes or unknown

Brief summary

To compare the radiographic Progression-Free Survival (rPFS) rate at 9 months of chemotherapy (Arm A, docetaxel plus prednisone) versus androgen receptor targeted therapy (Arm B, enzalutamide or abiraterone acetate plus prednisone) in mCRPC BRCA negative or unknown patients with adverse prognostic factors

Detailed description

To compare efficacy of docetaxel plus prednisone to enzalutamide or abiraterone acetate plus prednisone for: - PSA response rate; - Median rPFS; - Overall survival, To compare the safety of each treatment amog docetaxel abiraterone end enzalutamide, To compare Health-Related Quality Of Life (HRQOL) according to FACT-P questionnaire and Health status/utility (EQ-5D-5L) test

Interventions

DRUGENZALUTAMIDE

DRUGDOCETAXEL

DRUGABIRATERONE

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To compare the radiographic Progression-Free Survival (rPFS) rate at 9 months of chemotherapy (Arm A, docetaxel plus prednisone) versus androgen receptor targeted therapy (Arm B, enzalutamide or abiraterone acetate plus prednisone) in mCRPC BRCA negative or unknown patients with adverse prognostic factors	—

Secondary

Measure	Time frame
To compare efficacy of docetaxel plus prednisone to enzalutamide or abiraterone acetate plus prednisone for: - PSA response rate; - Median rPFS; - Overall survival, To compare the safety of each treatment amog docetaxel abiraterone end enzalutamide, To compare Health-Related Quality Of Life (HRQOL) according to FACT-P questionnaire and Health status/utility (EQ-5D-5L) test	—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026