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Table 2 Study calendar

From: BioPro-RCMI-1505 trial: multicenter study evaluating the use of a biodegradable balloon for the treatment of intermediate risk prostate cancer by intensity modulated radiotherapy; study protocol

  Within 60 days before the first day of radiation therapy Within 30 days before the first day of radiation therapy Within 3 weeks before the first day of radiation therapy During radiotherapy At the end of treatment Monitoring period Study exit
Before balloon implantation After balloon implantation
Clinical exams
 History of the disease, main health history, previous treatments X        
 Complete clinical examination with assessment of the general condition (Performance Status) X     X 1 / week X X X
 IPSS score X    X X At mid-treatment X X At 3, 6, 12 et 24 months X
Laboratory tests
 PSA level X       X At 3 months then every 6 months X
Quality of life
 EORTC-QLQ-C30 Questionnaire   X   X X At mid-treatment X X At 3, 6, 12 et 24 months X
 EORTC-QLQ-PR25 Questionnaire   X   X X At mid-treatment X X At 3, 6, 12 et 24 months X
Paraclinical exams
 Tumor evaluation by computed tomography scanner    X      
 Full description and measurements according to RECIST    X      
 Dosimetric computed tomography scanner    X X     
Treatments
 Side effects related to radiotherapy      X 1 / week X X At 3, 6, 12 et 24 months X