Table 1

Primary objectives and outcomes within the FINESSE trial

Objectives	Outcome measures	Timepoint(s) of evaluation of this outcome measure (if applicable)	Additional information
Primary objective: To compare adherence with AS in men with low or intermediate PCa with and without 2 years of finasteride during follow-up of between 3 and 5 years from randomisation. Adherence is defined as men who have received neither radical nor palliative treatment, and have remained under surveillance, at each timepoint.	Rate of either radical prostatectomy, radical radiotherapy, brachytherapy or prostate-cancer targeted treatment. Rate of use of systemic therapies. Rate of use of androgen deprivation therapy. Rate of other treatment for PCa. Rate of participant death from PCa. Rate of men discontinuing AS for any other reason.	All cessation from AS events from participants during follow-up of between 3 and 5 years from randomisation, will be included in the first analysis. Later analysis will use passive follow-up (up to 10 years after trial closure).	Rates in each arm will be measured by patient self-reporting. Participants who are lost to follow-up, or who die of a cause unrelated to PCa will be taken as censored.