Treatment phase (cycle length = 28 days) | Follow-up phase | ||||||||
---|---|---|---|---|---|---|---|---|---|
Required investigations | Baseline day −28 to 0 | Cycle 1 Day 1 | Cycle 1 Day 15 | Cycle 2 and 3 Day 1 | Cycles 4, 7, 10 (continue every 3rd cycle) Day 1 | Any other cycle, Day 1 | At treatment discontinuation | End-of-treatment visit | Follow-up visit (every 3 months) |
Procedures | |||||||||
Signed consent form | X | ||||||||
Medical history, prior Prostate cancer therapies | X | ||||||||
Worst pain within last 24 h | X | X | X | X | X | X | X | ||
Physical exam and weight | X | X | X | X | X | X | |||
Vital signs | X | X | X | X | X | X | X | ||
ECOG | X | X | X | X | X | X | X | ||
12-lead ECG | X | X | X | ||||||
Cardiac echo | X | X | |||||||
Dosing compliance | X | X | X | X | X | ||||
Concomitant medication | X | X | X | X | X | X | X | ||
Adverse events | X | X | X | X | X | X | X | X | |
Laboratory assessments | |||||||||
Hematology | X | X | X | X | X | ||||
Serum chemistry, electrolytes | X | X | X | X | X | X | |||
Liver function test | X | X | X | X | X | X | |||
Serum lipids | X | X | X | X | |||||
Plasma glucose | X | X | X | X | X | X | |||
PSA | X | X | X | X | X | X | |||
Serum testosterone, hormones | X | X | X | X | X | ||||
Tumor assessments | |||||||||
CT/MRI | X | X | X | X | |||||
Bone scan | X | X | X | X | |||||
Disease progression assessments | X | X | X | X | |||||
Next therapy for prostate cancer | X |