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Table 1 Schedule of the trial

From: Functional imaging-guided carbon ion irradiation with simultaneous integrated boost for localized prostate cancer: study protocol for a phase II randomized controlled clinical trial

 

Before radiation

During radiation

At the end of radiation (the final day of radiation)

Follow-up after treatment

Every week

The first year

The second and third years

The fourth year

From the fifth year

Weeks 4–6 (first time)

The 3rd month

The 6th month

The 12th month

Every 3 months

Every 6 months

Every year

Written informed consent

         

Medical history/physical examination

KPS, ECOG

Pathological diagnosis

         

Inclusion and exclusion criteria

         

Peripheral blood routine examination

a

Serum chemistry

a

Urine and stool routine examination

a

a

a

a

a

a

a

a

Levels of PSA, fPSA, testosterone, and NSE

 

Tests for HIV, syphilis

         

Tests for HBV, HCV

         

Cardiac function examination

         

CT of the chest

     

Annually

Annually

Annually

CT scan or ultrasound of the abdomen

 

mpMRI of prostate

 

Annually

Annually

Annually

Bone scan examination

a

     

Annually

Annually

Annually

68Ga-PSMA PET/CT

b

 

b

   

Annually

Annually

Annually

Evaluation of acute toxicities (NCI-CTACE)

  

  

Evaluation of late toxicities (RTOG/ EORTC)

    

EPIC

 

Annually

Annually

Annually

EQ-5D

 

Annually

Annually

Annually

IPSS

 

Annually

Annually

Annually

  1. awhen necessary
  2. brecommended