Androgen Deprivation therapy for Oligo-recurrent Prostate cancer in addition to radioTherapy (ADOPT): study protocol for a randomised phase III trial

Table 2 Follow up after radiotherapy treatment

Required investigation	Baseline	Treatment period		Follow-up
Required investigation	Baseline	Treatment period	1 m after RT	3 m after RT	6 m after RT	9 m after RT	12 m after RT	Every 6 (up to 36 months) months until progression^b
Eligibility check	X
Informed consent	X
ADT (arm 2)		X
Patient characteristics/ medical history	X		X	X	X	X	X	X
Laboratory assessment
PSA	X		X	X	X		X	X
Testosterone	X		X		X		X	X
Hb	X			X	X		X	X
ALP	X			X	X		X	X
Whole body PSMA PET/CT^a	X						X	Every 12 months
Treatment and dosimetric data		X
Toxicity & QoL
CTCAE v4	X	X^c	X	X	X		X	X
RTOG-EORTC toxicity	X	X^c	X	X	X		X	X
EORTC-QlQ-25	X				X	X	X	X
EORTC-QLQ-C-30	X				X		X	X
SAE		X	X	X	X	X	X	X^d

^a PSMA before inclusion, at progression and for patients without progression only at 12 and 24 months
^b 36 months visit, only lab, EORTC-QLQ-C-30 and CTCAE toxicity criteria
^c only in case of WPRT or prostate bed RT, the toxicity measurements should be intended at 4th week of treatment course
^d Until 2.5 years after treatment completion

ISSN: 1471-2407