NCT05974774 Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors
| NCT ID | NCT05974774 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | European Organisation for Research and Treatment of Cancer - EORTC |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,600 participants |
| Start Date | 2025-05-23 |
| Primary Completion | 2035-05-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,600 participants in total. It began in 2025-05-23 with a primary completion date of 2035-05-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study addresses the global topic of treatment optimization, i.e. achieving similar benefit while reducing the duration of treatment, hence hoping to decrease the burden of side-effects, improve quality-of life and reduce resource utilization. The primary goal of de-escalation is to investigate whether using an intermittent regime results in a similar OS to continuous treatment.
Eligibility Criteria
Inclusion Criteria: * Patient treated with ADT and an ARPI for mHNPC for 6-12 months and presenting with a PSA ≤ 0.2 ng/mL Note: Patient may have received docetaxel and radiotherapy of the prostate and metastases Note: Patients with synchronous or metachronous metastases, high volume/risk 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 Exclusion Criteria: * 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
Contact & Investigator
Bertrand Tombal, Prof
STUDY CHAIR
Cliniques Universitaires de Saint Luc
Frequently Asked Questions
Who can join the NCT05974774 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 100 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05974774 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,600 participants.
Is NCT05974774 currently recruiting?
Yes, NCT05974774 is actively recruiting participants. Contact the research team at eortc@eortc.org for enrollment information.
Where is the NCT05974774 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Caen, France, Grenoble, France, Quint-Fonsegrives, France and 5 additional locations.
Who is sponsoring the NCT05974774 clinical trial?
NCT05974774 is sponsored by European Organisation for Research and Treatment of Cancer - EORTC. The principal investigator is Bertrand Tombal, Prof at Cliniques Universitaires de Saint Luc. The trial plans to enroll 1,600 participants.
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