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EORTC-2238-GUCG: Improving impact of anti-androgen treatments on patient's daily life and their cancer
EU CTIS ID: 2023-506817-23-01
What this study is testing
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)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient treated with ADT (luteinizing hormone–releasing hormone (LHRH) agonist or antagonist) and an ARpI for mHNPC for 6-12 months and presenting with a PSA ≤ 0.2 ng/mL
- Patients with synchronous or metachronous metastases, high volume or low volume/risk who fulfil the criteria can be included.
- Before patient's enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations
You likely can't join if
- Patients with M1a on modern imaging technique (PET-Choline or -PSMA or Whole Body MRI) for whom radiation therapy and 2-3 years of hormone therapy is planned
- Patients who underwent or will undergo a bilateral orchiectomy
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment for this trial
- Patients who have received a systemic anti-prostate cancer treatment not approved by EMA together with MAB or a radical prostatectomy for M1 disease
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.