EORTC-2238-GUCG: Improving impact of anti-androgen treatments on patient's daily life and their cancer

Brief summary (registry, in English)

The primary objective of this phase III trial is to establish the risk/benefit ratio of intermittent maximum androgen blockade (iMAB) vs. continuous MAB (cMAB) in mHSPC patients with a deep PSA response (PSA≤ 0.2 ng/mL) after 6 to 12 months with ADT and one of the registered ARpI. The primary objective will be addressed through the following coprimary objectives: 1) To demonstrate among patients from the iMAB arm that the proportion of patients who do not restart their hormonal therapy within 1 year of interrupting their MAB therapy is ≥ 70% (feasibility endpoint) 2) To show that the overall survival (OS) from randomization using an iMAB regimen is non-inferior to continuous treatment (pertinence endpoint)

What you commit to

• Study type: Interventional · Phase 3
• Planned participants: 1404
• 93 sites in 10 countries
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (93)

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