Required investigation | Inclusion (within 4 wk. prior to randomisation) | During treatment | Follow-up | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
4 wks | 7 wks | 1.5 m after RT | 3 m after RT | 6 m after RT | 9 m after RT | 12 m after RT | 18 m after RT | 24 m after RT | Every 12 m (up to 60 m) | ||
Eligibility check | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | |
Informed consent | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | |
Characteristics | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | |
Medical history / medication list | X | Â | X | X | X | X | X | X | X | X | |
WHO performance status | X | Â | X | Â | X | Â | X | X | X | X | |
pT-stage and GSS | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | |
PSA | X | Â | X | X | X | X | X | X | X | X | |
Testosterone | X | Â | Â | Â | Â | Â | X | Â | X | X | |
PSMA/PET CT | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | |
Radiotherapy treatment planning | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | |
Survival / progression status | Â | Â | X | X | X | X | X | X | X | X | |
Surveys | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | |
CTCAE v5 | X | Xa | X | X | X | X | X | X | X | X | |
RTOG-EORTC Toxicity | X | Xa | X | X | X | X | X | X | X | X | |
EORTC-QLQ-PR25 | X | Â | Â | X | X | X | X | X | X | X | |
EORTC-QLQ-C30 | X | Â | Â | Â | X | X | X | X | X | X | |
SAE | Â | Â | X | X | X | X | X | X | X | X |