N=~800
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Key eligibility criteria*:
- Histologically confirmed adenocarcinoma of the prostate
- ECOG PS 0 or 1
- Progressed on ≥1 novel ARPI, but received ≤2 ARPI for any disease stage, and discontinued any ARPI prior to randomization
- Prior bilateral orchiectomy, serum testosterone ≤50 ng/dL, or receiving ongoing ADT with a GnRHa throughout treatment
- No prior treatment with KLK2-directed therapies
- No prior chemotherapy for prostate cancer
- Participants with known BRCA1/2 mutations must have been previously treated with PARPi, unless not available or contraindicated
Primary outcome:
- rPFS
Secondary outcomes:
- OS
- Time to symptomatic progression
- Time to subsequent therapy
- Time to skeletal-related event
- Objective response rate
- DOR
- Time to PSA progression
- PSA-50 response
- PSA-90 response
- Duration of PSA response
- PFS2
- AEs and SAEs
- Clinical laboratory abnormalities
- HRQoL
*Not a complete list of inclusion and exclusion criteria.
ADT, androgen deprivation therapy; AE, adverse event; ARPI, androgen receptor pathway inhibitor; BRCA, breast cancer gene; CD, cluster of differentiation; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; GnRHa, gonadotropin-releasing hormone analog; HRQoL, health-related quality of life; KLK2, human kallikrein-2; mCRPC, metastatic castration-resistance prostate cancer; OS, overall survival; PARPi, poly (ADP-ribose) polymerase inhibitor; PFS2, progression-free survival after subsequent therapy; PSA, prostate-specific antigen; PSA-50, reduction in blood concentration of PSA (ng/mL) to 50% from baseline; PSA-90, reduction in blood concentration of PSA (ng/mL) to 90% from baseline; R, randomized; rPFS, radiographic progression-free survival; SAE, serious adverse event.