Table 3.
Summary of the follow-up in the first 5 years after RT
| 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 | ||||||||||
| Informed consent | X | ||||||||||
| Characteristics | X | ||||||||||
| Medical history / medication list | X | X | X | X | X | X | X | X | X | ||
| WHO performance status | X | X | X | X | X | X | X | ||||
| pT-stage and GSS | X | ||||||||||
| PSA | X | X | X | X | X | X | X | X | X | ||
| Testosterone | X | X | X | X | |||||||
| PSMA/PET CT | X | ||||||||||
| Radiotherapy treatment planning | X | ||||||||||
| Survival / progression status | X | X | X | X | X | X | X | X | |||
| Surveys | |||||||||||
| 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 | X | X | X | X | X | X | X | |||
| EORTC-QLQ-C30 | X | X | X | X | X | X | X | ||||
| SAE | X | X | X | X | X | X | X | X | |||
aHave to be completed at the end of radiotherapy (4 weeks in the experimental arm and 7 weeks in the standard arm)