A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of [177Lu]LU-PSMA-I&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer

Conditions

metastatic Castration-Resistant Prostate Cancer (mCRPC)

Brief summary

Time from randomization to radiographic progression as determined by Prostate Cancer Working Group 3 (PCWG3) criteria as assessed by blinded independent central review

Detailed description

Time from randomization to death by any cause, Time from randomization to the second radiographic progression as determined by PCWG3 or RECIST 1.1 by Blinded Independent Central Review (BICR) after crossover, Time from randomization to progression (PFS, composite) based on the following events, whichever occurs first: PCWG3 or RECIST progression, clinical/symptomatic progression and/or pain progression, or death due to any cause as determined by investigator., Time from randomization to the second progression (PFS, composite) based on the following events, whichever occurs first: PCWG3 or RECIST progression, clinical/symptomatic progression and/or pain progression, or death due to any cause as determined by investigator., PSA50 response rate, defined as a confirmed reduction of PSA from baseline of ≥ 50%, Time from randomization to first symptomatic skeletal event (SSE-free survival), Time from randomization to radiographic soft tissue progression (rSTP) as measured by RECIST 1.1 by BICR., Time from randomization to first use of chemotherapy, Quality of Life improvement based on EORTC QLQ-C30 questionnaire

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUG177LU-PSMA-I&T

DRUGPREDNISONE

DRUGENZALUTAMIDE

DRUGPylclari 1 000 MBq/mL solution for injection

DRUGABIRATERONE ACETATE

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time from randomization to radiographic progression as determined by Prostate Cancer Working Group 3 (PCWG3) criteria as assessed by blinded independent central review	—

Secondary

Measure	Time frame
Time from randomization to death by any cause, Time from randomization to the second radiographic progression as determined by PCWG3 or RECIST 1.1 by Blinded Independent Central Review (BICR) after crossover, Time from randomization to progression (PFS, composite) based on the following events, whichever occurs first: PCWG3 or RECIST progression, clinical/symptomatic progression and/or pain progression, or death due to any cause as determined by investigator., Time from randomization to the second progression (PFS, composite) based on the following events, whichever occurs first: PCWG3 or RECIST progression, clinical/symptomatic progression and/or pain progression, or death due to any cause as determined by investigator., PSA50 response rate, defined as a confirmed reduction of PSA from baseline of ≥ 50%, Time from randomization to first symptomatic skeletal event (SSE-free survival), Time from randomization to radiographic soft tissue progression (rSTP) as measure	—

Measure

Time frame

Time from randomization to death by any cause, Time from randomization to the second radiographic progression as determined by PCWG3 or RECIST 1.1 by Blinded Independent Central Review (BICR) after crossover, Time from randomization to progression (PFS, composite) based on the following events, whichever occurs first: PCWG3 or RECIST progression, clinical/symptomatic progression and/or pain progression, or death due to any cause as determined by investigator., Time from randomization to the second progression (PFS, composite) based on the following events, whichever occurs first: PCWG3 or RECIST progression, clinical/symptomatic progression and/or pain progression, or death due to any cause as determined by investigator., PSA50 response rate, defined as a confirmed reduction of PSA from baseline of ≥ 50%, Time from randomization to first symptomatic skeletal event (SSE-free survival), Time from randomization to radiographic soft tissue progression (rSTP) as measure

—

Countries

France, Italy, Spain

Outcome results

None listed