177Lu-PSMA-617 pour le cancer de la prostate résistant à la castration métastatique au Japon

177Lu-PSMA-617

68Ga-PSMA-11

Best supportive/best standard of care

Part 1 (safety run-in part): Dose Limiting Toxicity (DLT) during 1 cycle (6 weeks)

Part 2 (Post-taxane part) and Part 3 (Pre-taxane part): Overall Response Rate (ORR) based on local assessment

Part 2 and Part 3 (main part): Absorbed dose and Effective whole-body dose 68Ga-PSMA-11

Part 2 and Part 3 (main part): Overall Survival (OS)

Part 2 and Part 3 (main part): Radiographic Progression-Free-Survival (rPFS) based on local assessment

Part 2 and Part 3 (main part): Overall Response Rate (ORR) based on central review

Part 2 and Part 3 (main part): Percentage of Participants with treatment emergent adverse events

Part 2 and Part 3 (main part): Disease Control Rate (DCR) as per central and local review

Part 2 and Part 3 (main part): Duration of Response (DOR) based on local imaging

Part 2 and Part3 (main part): Time to first symptomatic skeletal event (SSE) of 177Lu-PSMA-617

Part 2 and Part 3 (main part): Progression Free Survival (PFS)

Part 2 and Part 3 (main part): Percentage of Participants with Biochemical Response as measured by Prostate Specific Antigen (PSA)

Part 2 and Part 3 (main part): Change from Baseline in European Quality of Life (EuroQol) - 5 Domain 5 Level scale (EQ-5D- 5L)

Part 2 and Part 3 (main part): Change from Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire

Part 2 and Part 3 (main part): Change from Baseline in Brief Pain Inventory - Short Form (BPISF) Questionnaire: Pain Severity Score

Part 2 and Part 3 (main part): Change from Baseline in Brief Pain Inventory - Short Form (BPISF) Questionnaire: Pain Interference Score

Part 2 and Part 3 (main part): Absorbed dose and Effective whole-body dose of 177Lu-PSMA-617

Part 2 and Part 3 (main part): Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of 68Ga-PSMA-11

Part 2 and Part 3 (main part): Time of maximum observed drug concentration occurrence (Tmax) of 68Ga-PSMA-11

Part 2 and Part 3 (main part): Observed maximum plasma concentration (Cmax) of 68Ga-PSMA-11

Part 2 and Part 3 (main study): Area Under the plasma concentration-time Curve from the time 0 to the last observed quantifiable concentration (AUC(0-t)) of 68Ga-PSMA-11

Part 2 and Part 3 (main study): AUC(0-t) divided by the dose administered (AUC(0- t)/D) of 68Ga-PSMA-11

Part 2 and Part 3 (main study): Terminal elimination half-life (T1/2) of 68Ga-PSMA-11

Part 2 and Part 3 (main study): Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) of 68Ga-PSMA-11

Part 2 and Part 3 (main study): Total systemic clearance for intravenous administration (CL) of 68Ga-PSMA-11

Part 2 and Part 3 (main study): volume of distribution during the terminal phase following intravenous elimination (Vz) of 68Ga-PSMA-11

Part 2 and Part 3 (main part): Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of 177Lu-PSMA-617

Part 2 and Part 3 (main part): Time of maximum observed drug concentration occurrence (Tmax) of 177Lu-PSMA-617

Part 2 and Part 3 (main part): Observed maximum plasma concentration (Cmax) of 177Lu-PSMA-617

Part 2 and Part 3 (main study): Area Under the plasma concentration-time Curve from the time 0 to the last observed quantifiable concentration (AUC(0-t)) of 177Lu-PSMA-617

Part 2 and Part 3 (main study): AUC(0-t) divided by the dose administered (AUC(0- t)/D) of 177Lu-PSMA-617

Part 2 and Part 3 (main study): Terminal elimination half-life (T^1/2) of 177Lu-PSMA-617

Part 2 and Part 3 (main study): Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) of 177Lu-PSMA-617

Part 2 and Part 3 (main study): Total systemic clearance for intravenous administration (CL) of 177Lu-PSMA-617

Part 2 and Part 3 (main study): volume of distribution during the terminal phase following intravenous elimination (Vz) of 177Lu-PSMA-617

Part 4 (expanded trial part): Overall Response Rate (ORR) based on local assessment

Part 4 (expanded trial part): Radiographic Progression-Free-Survival (rPFS) based on local assessment

Part 4 (expanded trial part): Progression Free Survival (PFS)

Part 4 (expanded trial part): Overall Survival (OS)