Secondary outcome measures
BONE METASTASES
Secondary outcomes include the following:(1) Progression-free survival from randomization to appearance of new bone metastases outside the field of targeted therapy on WB-DWI (according to BICR).(2) Progression-free survival from randomization to exacerbation of bone metastases on WB-DWI (according to each investigator’s judgment).(3) Progression-free survival from randomization to the appearance of new bone metastases outside the field of targeted therapy on WB-DWI (according to each investigator’s judgment).(4) Overall survival.(5) Time to PSA progression.(6) Changes in PSA.(7) Time to exacerbation of total alkaline phosphatase (ALP).(8) Total ALP response defined as a reduction of ≥ 30% from the baseline value, confirmed ≥ 4 weeks later.(9) Normalization of total ALP.(10) Changes in total ALP.(11) Interval between completion of targeted therapy and start of treatment with other hormone therapy, anticancer drugs or radiation therapy.(12) Therapeutic effect on bone metastatic lesions as assessed by MET-RADS-P at six months after completion of targeted therapy.(13) Therapeutic effect on whole metastatic lesions as assessed by MET-RADS-P at six months after completion of targeted therapy.(14) Quality of life (QOL): Changes in FACT-P at six months and one year after completion of targeted therapy.(15) QOL: Changes in EQ-5D at six months and one year after the completion of targeted therapy.