Enrolment | Baseline | Treatment period | End of study | ||||||
---|---|---|---|---|---|---|---|---|---|
Day - 60 | Day - 30 | 0 | Week 6 | Week 18 | Week 30 | Week 42 | Week 54 | Week 66 | |
Informed consent | X | ||||||||
Eligibility screen | X | X | X | ||||||
Tysabri® (routine care) | X | X | X | X | X | X | X | X | |
Clinical examination | X | X | X | X | X | X | X | X | |
Medical history | X | ||||||||
Prostate examination by a urologist | X | X | |||||||
Prostate-specific antigen | X | X | X | X | |||||
Blood test (*fasting) | X | X | X* | X* | X* | X* | X* | X* | X* |
Hormonal dosage | X | X | X | X | X | X | X | ||
MRI | X | X | X | ||||||
Nebido®/Placebo | X | X | X | X | X | X | X | ||
Scales and cognitive tests | X | X | X | ||||||
AE/concomitant treatments | X | X | X | X | X | X | X | X | X |