PEACE 6 – Vulnerable

About this trial

This is a Phase III, international, multicentre, randomised, double-blinded placebo controlled trial, evaluating the efficacy and safety of ADT +/- darolutamide in castration-naïve de novo metastatic prostate cancer patients with vulnerable functional ability who have not elected for docetaxel or other androgen receptor pathway inhibitors. The study plans to enroll 300 patients who will be randomized (1:1) to receive either: (i) Experimental arm: ADT + darolutamide 600 mg po bid, or (ii) Control arm: ADT + placebo po bid. Response to treatment will be assessed according to the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria (Scher, 2016).

Patient Profile

The target patient population for this study is castration-naïve de novo metastatic prostate cancer patients with vulnerable functional ability who have not elected for docetaxel or other androgen receptor pathway inhibitors

Where’s this trial being run?

Tallaght University Hospital and St Vincents University Hospital

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

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Questions?

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

Questions

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Summary Data

Name:	PEACE 6 – Vulnerable
Number:	20-32
Full Title:	A double-blind randomised phase III trial evaluating the efficacy of ADT +/- darolutamide in de novo metastatic prostate cancer patients with vulnerable functional ability and not elected for docetaxel or androgen receptor targeted agents

Principal Investigator:	Prof Ray McDermott
Type:	Collaborative
Sponsor:	UNICANCER
Recruitment Started:	Global: Ireland: October 2023

Global Recruitment Target:	300
Ireland Recruitment Target:	22