Table 1.

Time points at which outcomes are assessed

Time point	Outcome measure
Baseline	Participant demographics (Charlson Comorbidity Index, cancer history, DRE, PSA, current medications, body mass index, ethnicity) IIEF questionnaire (Domain A) I-PSS questionnaire EQ-5D-5L questionnaire
Immediately post-procedure	ProBE questionnaire (Perception part) Histological parameters (ISUP grade groupa, cancer core length, core involvement, target biopsy cancer parameters) Burden and rate of detection of clinically significant (GGG ≥ 2) PCa Burden and rate of detection of GGG ≥ 3 PCa Burden and rate of detection of clinically insignificant (GGG 1) PCa
7 days post-procedure	ProBE questionnaire (General Symptoms part) IIEF questionnaire (Domain A) I-PSS questionnaire EQ-5D-5L questionnaire Infection Complications and SAEs
35 days post-procedure	IIEF questionnaire (Domain A) I-PSS questionnaire EQ-5D-5L questionnaire Infection Complications and SAEs Number of subsequent prostate biopsy procedures
4 months post-procedure	IIEF questionnaire (Domain A) I-PSS questionnaire EQ-5D-5L questionnaire Infection Complications and SAEs Number of subsequent prostate biopsy procedures and details of the subsequent biopsies

^aIncludes the primary outcome measure, the difference in detection rates of clinically significant PCa, defined as Gleason Grade Group ≥ 2, i.e. any Gleason pattern ≥ 4 disease