Study period | ||||||||
---|---|---|---|---|---|---|---|---|
Pre-trial | Allocation | Post-allocation | ||||||
RC1 | RC2 | RC3 | ||||||
Timepoint | 0 | ~ 3 weeks | ~ 9 weeksa | 3 months | ~ 14 weeksb | 6 months | 12 months | |
Enrolment: | ||||||||
Eligibility screen | x | |||||||
Randomisation consent | x | |||||||
Informed consent | x | |||||||
Interview consent | x | |||||||
Assessments: | ||||||||
Demographic data | x | x | x | x | ||||
Family medical history | x | x | x | x | ||||
Height (cm) | x | |||||||
Weight (kg) | x | x | x | |||||
Blood sample | x | (x) | x | |||||
Leisure time physical activity [28] | x | x | x | x | ||||
Urinary symptoms [29] | x | x | x | x | x | |||
x | x | x | x | |||||
Patient function and bother [32] | x | x | x | x | ||||
x | x | x | x | |||||
Quality of life measures [35] | x | x | x | x | ||||
x | x | x | x | x | ||||
Lifestyle behaviours (drinking and smoking) | x | x | x | x | ||||
Prostate tissue | [x] | |||||||
Step count (pedometer) | x | x | x | x | ||||
Physical activity intensity/step count (Garmin) | x | x | x | |||||
Metformin tablet count | x | x | x | |||||
Qualitative interview | x |