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.
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
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
Parallel
iMAB
Drugno treatment until significant PSA increase as per treating physician at which point patient restarts ADT (LHRH agonist or antagonist) + ARPI (abiraterone or enzalutamide or apalutamide or darolutamide). Once PSA \< 0.2 ng/mL, treatment stops again.
cMAB
DrugLHRH agonist or antagonist + ARPI (abiraterone or enzalutamide or apalutamide or darolutamide)
overall survival
the overall survival (OS) using an iMAB regimen is non-inferior to continuous treatment.
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)
proportion of patients who do not restart within 1 year of interrupting their MAB therapy (given as part of the induction phase) is not less than 70%
occurrence of adverse events
Safety according to the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0 for toxicity and Serious Adverse Event reporting.
Time spent on MAB treatment
the overall time in months that the patient was on MAB treatment
Time to next systemic prostate cancer therapy
the overall time in months until the patient began the next systemic prostate cancer therapy
The magnitude of change in HRQoL
The magnitude of change in HRQoL in terms of physical functioning from EORTC QLQ-C30
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European Organisation for Research and Treatment of Cancer - EORTC
Lead sponsor
Cancer Trials Ireland
Collaborator
UNICANCER
Collaborator
Spanish Oncology Genito-Urinary Group
Collaborator
