Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors
Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors; a Phase 3 Pragmatic Randomized Trial.
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC + Cancer Trials Ireland, UNICANCER
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
overall survival
Time frame: 10 years from randomisation
proportion of patients who do not restart their hormonal therapy within 1 year of interrupting their MAB therapy (given as part of the induction phase)
Time frame: 1 year from stopping the MAB therapy
Secondary Endpoints
occurrence of adverse events
Time spent on MAB treatment
Time to next systemic prostate cancer therapy
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 o…
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