TIMEPOINT | STUDY PERIOD | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Screening | Allocation | Treatment period | Follow-up period | |||||||
Within 8 weeks prior to randomization | Within 2 weeks prior to randomization | Baseline | Start | During | End | 1 month after treatment ± 7 days | 3 months after treatment ± 14 days | 6 months after treatment ± 14 days | 6-monthly, yearly, until progression (g) ± 14 days | |
Window | ||||||||||
ENROLMENT: | ||||||||||
Eligibility screen | x | |||||||||
Signed ICF | x | |||||||||
Randomization | x | |||||||||
INTERVENTIONS (a,b): | ||||||||||
If sLND | x | x | x | |||||||
If WPRT | x | x | x | |||||||
If SBRT | x | x | x | |||||||
ADT | x | x | x | x | x | x | ||||
ASSESSMENTS: | ||||||||||
Medical history | x | |||||||||
Patients characteristics | x | |||||||||
Physical exam (c) | x | x | x | x | x | x | ||||
Lab | ||||||||||
PSA | x | x (h) | x | x | x | x | ||||
Testosterone | x | x | x | x | x | |||||
Biomarker | x | x (i) | ||||||||
Imaging | ||||||||||
PET-CT (d) | x | (x) | (x) | (x) | ||||||
MRI (e) | x | |||||||||
Adverse Events | ||||||||||
Baseline toxicity | x | |||||||||
Acute toxicity (f) | (x) | (x) | x | x | x | |||||
Late toxicity | x | x | ||||||||
Medication | ||||||||||
Prior medication | x | |||||||||
Con med’s | x | x | x | x | x | |||||
Quality of life | ||||||||||
QLQ-C30 | x | x | x | x | ||||||
QLQ-PR25 | x | x | x | x | ||||||
Survival status | x | x | x | x |