Table 2.
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 |