TABLE 1

Study Protocol Demonstrating Data Collected at Each of 4 Patient Visits

Event	Visit 1 prescan data (≤4 wk before scan)	Visit 2 (day of scan)	Visit 3, by telephone (next working day)	Visit 4, outpatient (∼2 wk after scan)^*
Eligibility confirmation	X
Informed consent	X
Demographics	X
Medical history, including prostate cancer treatment history and imaging history	X	X
Physical examination^†	X	X		X
ECOG performance status	X			X
Concomitant medications	X	X	X	X
Management plan^‡	X			X
Study registration	X
Serum full blood count, urea, electrolytes, liver function tests, PSA	X			X
Urinalysis	X			X
Cardiovascular profile (electrocardiography)	X	X^§		X
Vital signs	X	X^‖		X
⁶⁸Ga-THP PSMA PET/CT administration and imaging		X
AEs		X	X	X

↵* Window of 0–6 wk was permitted, depending on local clinical practice.
↵† Comprised height (visit 1 only), weight, body surface area, and description of external signs of cancer.
↵‡ It was recognized that revised management plan might be decided on before outpatient appointment, and this was permitted. Deciding management plan outside of visit did not constitute protocol deviation.
↵§ Electrocardiography: visit 2, approximately 1 h before scan.
↵‖ Vital signs: visit 2, before scan, during injection, after scan (for 2 h after injection), and before discharge.
ECOG = Eastern Cooperative Oncology Group.