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Table 1 Study visits and procedures

From: Metastasis-directed therapy in castration-refractory prostate cancer (MEDCARE): a non-randomized phase 2 trial

 Screen visitPre MDT (SBRT or surgery)Last day of MDT (SBRT or surgery)Follow-up
M1, M3, M6, M9, M12
M15, M18, M21, M24
Informed consentX       
Clinical examinationX XXXXXX
Laboratory analysisX XXXXXX
Registration of pre-treatment morbidities X      
Registration of QOL using validated questionnaires X XXXXX
Registration of MDT induced toxicity (CTCAE for radiotherapy or Clavien-Dindo for metastasectomy)  XXXXXX
Standard imaging (after MTB decision)XX (imaging at month M6, M12, M18 and M24 and at any time in case of PSA progression or symptoms)
Investigational Imaging (18F PSMA-PET CT)X (Blinded)X (in case of PSA rise (confirmed once), radiographic progression on standard imaging or symptoms)
  1. X reflects the timepoint of a certain assessment
  2. MDT metastasis-directed therapy, SBRT stereotactic body radiation therapy, QOL quality of life, CTCAE Common Toxicity Criteria of Adverse Effects, MTB multidisciplinary tumor board, PSA prostate specific antigen, PSMA PET-CT prostate-specific membrane antigen positron emission tomography-computed tomography