DASL-HiCaP: Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (ANZUP1801). A randomised phase 3 double-blind, placebo-controlled trial of adding darolutamide to androgen deprivation therapy and definitive or salvage radiation in very high risk, clinically localised prostate cancer.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514565-18-00

Enrollment

Registered

2024-07-29

Start date

2021-07-20

Completion date

Unknown

Last updated

2024-11-14

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

Conditions

Localised Very High-Risk Cancer of the Prostate

Brief summary

Metastasis-free Survival (MFS)

Detailed description

Overall Survival (OS), Prostate cancer-specific Survival, PSA Progression-free Survival, Time to Subsequent Hormonal Therapy, Time to Castration Resistance (PCWG3 criteria), Frequency and severity of adverse events, Health Related Quality of Life (HRQL), Fear of Cancer Recurrence, Incremental cost-effectiveness, Prognostic/predictive biomarkers

Interventions

DRUGBAY 1841788

DRUGPlacebo to BAY1841788 film-coated tablet 300 mg

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Metastasis-free Survival (MFS)	—

Secondary

Measure	Time frame
Overall Survival (OS), Prostate cancer-specific Survival, PSA Progression-free Survival, Time to Subsequent Hormonal Therapy, Time to Castration Resistance (PCWG3 criteria), Frequency and severity of adverse events, Health Related Quality of Life (HRQL), Fear of Cancer Recurrence, Incremental cost-effectiveness, Prognostic/predictive biomarkers	—

Countries

Ireland

Outcome results

None listed

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