Clinical Trial

QLC5508 in Participants With Metastatic Prostate Cancer

Not Yet Recruiting Phase 3
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Summary
This is a randomized, open-label, active-controlled, multicenter Phase III trial evaluating QLC5508 versus docetaxel in participants with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after prior treatment with novel hormonal agents (NHAs). Participants are randomized to receive either QLC5508 monotherapy (experimental arm) or docetaxel (control arm). The primary objective is to compare the efficacy of QLC5508 versus docetaxel, as measured by radiographic progression-free survival (rPFS) assessed by an Independent Radiological Review Committee (IRC).
Trial Details
NCT Number NCT07632690
Lead Sponsor Qilu Pharmaceutical Co., Ltd.
Conditions Prostate Cancer
Enrollment 700 participants
Start Date 2026-06-20
Primary Completion 2028-06-20 (estimated)
Study Completion 2030-11-20 (estimated)
Updated on ClinicalTrials.gov 2026-06-08