AcTFirst: Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC

Time to death due to any cause.

Time to first documented progression or death due to any cause.

Time to first documented progression on next line of antineoplastic therapy or death from any cause.

The proportion of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR) in soft tissue.

The proportion of participants with BOR of confirmed CR, PR, stable disease (SD) or non-CR/non-progressive disease (PD) in soft tissue.

Time between the date of first documented response and the date of first documented radiographic progression or death due to any cause.

Time to radiographic soft tissue progression.

Time to date of first new symptomatic skeletal event of death due to any cause.

The percentage of participants who achieved ≥ 50% and ≥ 90% decrease from baseline, respectively.

Time-concentration profiles and PK parameters of AAA817 (e.g. AUC, Cmax).

Change from baseline on FACT-P Prostate Cancer Subscale (PCS). FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment.

Time to worsening on the Worst Pain is defined as the time from randomization to the first occurrence of worsening on the Worst Pain item (BPI-SF) or death due to any cause, whichever occurs first.

rPFS time to the date of first documented radiographic disease progression or death due to any cause, whichever occurs first.

Time to radiographic disease progression, using by blinded independent central review (BICR) using conventional imaging and Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1 criteria or death due to any cause.

Time to death due to any cause.