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About this trial

Denosumab is used for the prevention of skeletal related events in adults with bone metastases from solid tumours. Significant symptomatic and survival benefits have also been demonstrated with the use of the anti-androgens e.g. Enzalutamide in patients with advanced castration resistant prostate cancer. This study investigates the progression free survival of patients treated with a combination of Denosumab and Enzalutamide in progressive metastatic castrate-resistant prostate cancer. Patients receive a subcutaneous injection of Denosumab on day 1 of each 4 week cycle for 24 cycles and Enzalutamide capsules 160mg orally daily. All patients who are eligible for this study receive both Denosumab and Enzalutamide. Patients will attend for a study visit every 4 weeks for approximately 24 months.

Patient Profile

Localized Intermediate Risk Prostate Cancer

Where’s this trial being run?

Cork University Hospital, Sligo University Hospital, Tallaght University Hospital, St Vincents University Hospital, University Hospital Limerick, University Hospital Galway, and University Hospital Waterford

Can I join this study / trial?

The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.

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For more detailed information

Questions?

Here’s a list of questions you may have for your doctor or local cancer research team.

Summary Data

Name: DICE Study
Number: CTRIAL-IE 17-17
Full Title:

DICE Study A Phae II study of Denosumab In Combination with Enzalutamide in progressive metastatic castrate-resistant prostate cancer and bone metastases

Principal Investigator:
Type:
Sponsor:

Cancer Trials Ireland

Recruitment Started: Global: February 2019
Ireland: February 2019
Global Recruitment Target: NA Ireland only
Ireland Recruitment Target: 88