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Table 1 Summary of the main trail activities

From: Neoadjuvant degarelix with or without apalutamide followed by radical prostatectomy for intermediate and high-risk prostate cancer: ARNEO, a randomized, double blind, placebo-controlled trial

Activities

Visits

Perioperative period

 

Screening

V1

   

V2

   

V3

   

V4

T

PO

Cycles (weeks)

 

1

2

3

4

5

6

7

8

9

10

11

12

     

Randomization

 

X

                

Drugs dispensation

 

X

   

X

   

X

        

Informed consent

X

                 

Inclusion/exclusion criteria

X

X

                

Questionnaires IIEF5, ICIQ EORTC, QLQ-C30

 

X

           

X

  

X

 

PSA

X

    

X

   

X

   

X

  

X

 

Testosterone

 

X

           

X

  

X

X

SHBG

 

X

           

X

    

Blood and urine sampling for research purposes

 

X

           

X

    

Anestesiological visit

             

X

    

RP + PLND

              

X

   

Charlson comorbidity index

 

X

                

Clavien-Dindo

               

X

  

PSMA PET/MR

X

            

X

    
  1. V: visit. T: treatment. PO: postoperative. SHBG: sex hormone binding globulin
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