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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 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)

  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
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BMC Cancer

ISSN: 1471-2407

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