Table 1

Summary of INTERVAL-GAP4 assessments

	Screening	On-treatment study period (each cycle=28 days)																									Off-treatment
	Screening	Cycle 0: baseline	Supervised exercise								Transition			Self-managed exercise programme													Follow-up period
Cycle		0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21	22	23	24
Informed consent	X
Randomisation	X
Clinical history
Medical history*	X																									X
Medication/treatment history	X				X			X			X			X			X			X			X			X
Body measurements
Weight, waist, hip circumference, height (at baseline only)	X							X						X						X						X
Lab studies
CBC w/diff, blood chemistries	X							X						X
Fasting lipid profile, fasting glucose, haemoglobin A1c		X						X
Efficacy
Overall survival, disease progression, symptomatic-skeletal event†								X						X						X						X	Twice yearly
WHO Analgesic Scale	X				X			X			X			X			X			X			X			X	Once yearly
Exercise testing—supervised arm	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Exercise testing—self-directed arm		X						X						X						X						X
Safety
Medical clearance	X							X						X						X						X
Vital signs	X	X						X						X						X						X
ECOG performance status	X				X			X			X			X			X			X			X			X
Bone pain at exercise visits		Assessed at each supervised exercise visit using VAS
Adverse events‡	X		X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Concomitant medications	X		X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Metabolic research studies
Research blood (fasting)		X						X						X												X
FFPE tumour specimens		Request
Urine specimens		X						X						X												X
Patient-reported outcomes
Demographics and health history questionnaire	X
Exercise screening questionnaire	X
Exercise, quality of life and memory questionnaires (3-month or 6-month intervals, depending on survey)	X				X			X			X			X			X			X			X			X	X§
Food Frequency Questionnaire	X													X												X

*New conditions diagnosed on-study are recorded during the on-study period.
†Per review of medical records or other documentation. Mortality data will be collected through medical records, death records and other resources every 6 months during the on-treatment and follow-up periods. If the participant is lost to follow-up, we will contact next of kin or alternate contact. Death certificates will also be requested and all medical information pertaining to the death will be centrally reviewed to determine cause of death.
‡Continuously reported from informed consent until 28 days after cycle 24, day 1.
§Selected assessments will be administered during the follow-up period on a yearly basis. If no response is received from the participant and medical records do not indicate death, we will follow up with next of kin or alternate contact.
CBC, Complete Blood Count; WHO, World Health Organisation; VAS, Visual Analog Scale; ECOG, Eastern Cooperative Oncology Group; FFPE, formalin-fixed paraffin-embedded; INTERVAL-GAP4, Intense Exercise for Survival among Men with Metastatic Castrate-Resistant Prostate Cancer - Global Action Plan 4