Metformin and longevity (METAL): a window of opportunity study investigating the biological effects of metformin in localised prostate cancer

Table 5 Trial Flow Chart

Phase	Screening	Pre-surgery Treatment			Surgery	Post-surgery
Time point	≤14 days before baseline	Baseline Day 1 of treatment	Day 21 (+/- 2 days)	Day 28 (+/- 1 week) prior to surgery	Day 28 (+/- 1 week)	8-10^f weeks post-op
Informed consent	x
Eligibility review	x	x
Randomisation		x
Medical History^a	x
Demographics	x
Physical Exam	x	x	x	x		x
Vital signs^b	x		x	x		x
ECOG PS	x	x	x	x		x
Height	x
Weight	x			x		x
Waist/Hip ratio	x			x		x
Haematology	x		x	x		x
Biochemistry^c	x		x	x		x
Fasting Glucose/Lipids	x			x
PSA and Testosterone	x			x		x
HbA1c	x
Whole blood and Serum save^d	X			X
Study Drug Administration		x	x	x
Medication review	x	x	x	x		x
Compliance evaluation (diary and verbal)			x	x
Adverse events (CTCAE v4)^e		x	x	x		x
Paraffin embedded tissue sent to laboratory	x				x
Prostatectomy					x
MRI safety assessment^g	x
¹⁸F Choline PET/MRI^g	x			X^e

^aFull medical history, including history other disease, active or resolved, concomitant illnesses and cancer diagnosis
^bBlood pressure, pulse rate and oxygen saturation, BM
^cRenal profile, liver function tests, bone profile
^dTo be taken at selected sites only and according to the Trial specific SOP
^eClavien Dindo assessment to be completed at 8-10 weeks post operatively
^fThis review will coincide with routine post-operative review
^gOnly for the 5 subjects participating in the exploratory PET-MRI group

ISSN: 1471-2407