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Table 4 Schedule of patient assessments through the study period

From: SABR-Dual: a phase II/III trial of two-fraction versus five-fraction stereotactic radiotherapy for localized low- and favorable intermediate-risk prostate cancer

Schedule of Assessments

Notes

Visit Name

SCR

Simulation & treatment

2-week toxicity assessmenta

1st year follow upb

Follow up years 2-5c

Follow up year 6 and thereafterd

 

Medical history

X

      

Concomitant medication review

X

     

Adverse events assessment

 

X

X

X

X

 

Physical examination

X

 

X

X

X

 

PSA

X

 

X

X

X

Staging PSA will be obtained within 1 month prior to enrollment

IPSS

X

 

X

X

X

 

EPIC

X

 

X

X

X

 

SHIM

X

 

X

X

X

 

Hydrogel spacer insertion

X

      

Staging PET CT/CT/Bone scan

X

     

optional

Prostate MRI

X

   

X

 

2-year MRI per physician recommendation

Prostate biopsy

    

X

 

Following the 2-year MRI– biopsy should be both targeted and systematic

  1. a. For the first three patients. b. During the 1st -year, follow up will be performed at 1, 3, 6, 9, and 12 months. c. Every 6 months. d. Annually