Table 1.
Study calendar
Visits | Inclusion | Treatment period | follow-up | |||
---|---|---|---|---|---|---|
Visits | Max 2 months prior to RT day 1 | M1 1 month after end of RT | Before progression | After progression | ||
Every 6 months during 2 years | Every 6 months until progression | Every 6 months until death | ||||
Inclusion/exclusion criteria | X | |||||
Signed consent form | X | |||||
Inclusion (max 2 months prior to RT) | X | |||||
FCH PET | X (a) | X (b) | ||||
Physical examination with PS | X | X (d) | X | X | X | X |
Prior history, tumor characteristics | X | |||||
Blood Pressure | X | X (d) | X | X | ||
Acute toxicity during ADT and RT (f) | X (d) | X | ||||
Late toxicity (f) | X | |||||
QLQ-C30 et QLQ-PR25 | X | X | X | |||
PSA | X | X (f) | X (f) | X (f) | ||
Testosterone | X (g) | X | X | X | ||
ADT (c) + RT | X |
(a) maximum 3 months prior to initiation of ADT
(b) at progression
(c) 6 months treatment staring on RT day 1 or maximum 3 months prior to RT
(d) once per week during RT
(e) biochemical progression = PSA higher than inclusion PSA with 2 successive rises in the same laboratory
(f) NCI-CTCAE v4.0
(g) 28 days prior to ADT