Trial intelligence / Profile preview

ARASTEP darolutamide plus ADT in high-risk biochemical recurrence of prostate cancer

2022-501343-33-00Phase 3Authorised

Sponsor
Bayer
Start
Jul 2023
Modality
Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules
Countries
23
01

Overview

Phase 3, randomised, double-blind trial in prostate cancer (PCa) comparing Darolutamide + ADT with Placebo + ADT (2 arms). Primary endpoint: rPFS by PSMA PET/CT assessed by BICR. Planned start Jul 2023; status: authorised.

02

Drugs

darolutamide
03

Conditions

prostate cancer (PCa)

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