Screen visit | Pre MDT (SBRT or surgery) | Last day of MDT (SBRT or surgery) | Follow-up M1, M3, M6, M9, M12 M15, M18, M21, M24 | |||||
---|---|---|---|---|---|---|---|---|
Informed consent | X | |||||||
Clinical examination | X | X | X | X | X | X | X | |
Laboratory analysis | X | X | X | X | X | X | X | |
Registration of pre-treatment morbidities | X | |||||||
Registration of QOL using validated questionnaires | X | X | X | X | X | X | ||
Registration of MDT induced toxicity (CTCAE for radiotherapy or Clavien-Dindo for metastasectomy) | X | X | X | X | X | X | ||
Standard imaging (after MTB decision) | X | X (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) |