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
European Organisation for Research and Treatment of Cancer - EORTC
Lead sponsor
Cancer Trials Ireland
Collaborator
UNICANCER
Collaborator
Spanish Oncology Genito-Urinary Group
Collaborator