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

Table 2 Study calendar

	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
	Within 60 days before the first day of radiation therapy	Within 30 days before the first day of radiation therapy	Before balloon implantation	After balloon implantation	During radiotherapy	At the end of treatment	Monitoring period	Study exit
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

ISSN: 1471-2407