DASL-HiCaP

Current Clinical Trials

Prostate — In Follow-up

The purpose of this study is to see if a new tablet drug, darolutamide, combined with the current best treatments, can improve outcomes for people with high risk prostate cancer that has not spread beyond the prostate area. Previous studies have shown promising results for darolutamide preventing disease progression and improving survival for people with advanced prostate cancer.

DASL-HiCaP is being led internationally by ANZUP with another exciting opportunity to collaborate with our partners at the NHMRC Clinical Trials Centre, the Canadian Cancer Trials Group, Cancer Trials Ireland (Ireland and UK), and the Memorial Sloan Kettering Cancer Center and Prostate Cancer Clinical Trials Consortium in the US. The University of Sydney is the Sponsor and and the NHMRC Clinical Trials Centre is the global coordinating centre. We thank and acknowledge Bayer for providing funding and product for the DASL-HiCaP Trial.

The trial is now closed to recruitment, and enrolled 1,106 people from Australia, New Zealand, Canada, US, Ireland, and the UK.

If you think this trial might be right for you, please ask your doctor.

TRIAL TITLE

Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate

CONSUMER TITLE

Trial assessing whether adding darolutamide to standard treatment improves outcomes for people with high-risk prostate cancer that has not spread beyond the prostate. Participants are randomly assigned to different treatment groups.

CANCER TYPE

Prostate

TRIAL STATUS

In Follow-up

PROTOCOL NUMBER

ANZUP 1801

CO-ORDINATING CENTRE

NHMRC Clinical Trials Centre

STUDY CHAIR

Prof Christopher Sweeney and Assoc/Prof Tamim Niazi

PATIENT POPULATION

People aged 18 years or older with either very high-risk localised prostate cancer, or very high risk features with PSA persistence or rise within one year following radical prostatectomy, suitable for RT.

RECRUITMENT TARGET

1100

ACKNOWLEDGEMENT

DASL-HiCaP is an ANZUP investigator-initiated study is being led by ANZUP in collaboration with the NHMRC Clinical Trials Centre, Canadian Cancer Trials Group, Cancer Trials Ireland, Memorial Sloan Kettering Cancer Center, and the Prostate Cancer Clinical Trials Consortium. We thank Bayer for providing funding and study drug for the DASL-HiCaP Trial.