A Study of the Clinical Activity and Safety of JNJ-64041809, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Apalutamide Versus Apalutamide in Subjects With Metastatic Castration-resistant Prostate Cancer

PSA Doubling Time (PSADT)

The PSADT will be determined using the method as recommended by PCWG3 criteria.

Time frame: approximately 2 years

Radiographic Progression-free Survival

Radiographic progression-free survival, is defined as the time from the date of randomization to the date of radiographic progression or death, whichever occurs first.

Time frame: approximately 2 years

Time to Unequivocal Clinical Progression

Time to unequivocal clinical progression defined as the time from the date of randomization to the date of unequivocal clinical progression as evaluated by the investigator.

Time frame: approximately 2 years

Overall Survival

Overall survival defined as time from the date of randomization to death from any cause.

Time frame: approximately 2 years

Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability

Comparison of the AE profiles of the two treatment groups.

Time frame: approximately 2 years

Blood Culture and Shedding Profile of JNJ-809 From Cultured Samples of Feces, Urine, and Saliva

Blood culture samples will be collected after the mandatory prophylactic antibiotic therapy. Bacterial shedding will be evaluated from cultured samples of feces by stool or rectal swab, urine, and sputum.