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Table 1 Summary of time schedules, events and follow-up

From: Functional imaging guided stereotactic ablative body radiotherapy (SABR) with focal dose escalation and bladder trigone sparing for intermediate and high-risk prostate cancer: study protocol for phase II safo trial

Study Procedure

Screening

visit

During SABR Protocol treatment

Follow-up

  

During SABR treatment

End of SABR treatment

Year 1–2

First month and every 3months

Years 3

Every 6 months

End of study

Medical history and physical examination

X

  

X

X

X

Informed consent

X

     

Concomitant medications

X

 

X

X

X

X

Bood counts, Serum chemistry

PSA/Testosterona

X

  

X

X

X

Urinary or rectal comorbidities

X

X

X

X

X

X

Adverse events

X

X

X

X

X

X

Prostate MRI

X

  

X

X*

 

Standard imaging work up

X#

     

PET–TC (PSMA or Choline in High Risk

X#

     

QoL questionaires

X

 

X

X

X

X

Urinary and rectal events and grades

X

X

X

X

X

X

Survival

X

 

X

X

X

X

  1. *: at 3 months and 6–12 months when required
  2. #: At screening and when required