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.