Clinical Research Directory
Browse clinical research sites, groups, and studies.
QLC5508 in Participants With Metastatic Prostate Cancer
Sponsor: Qilu Pharmaceutical Co., Ltd.
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).
Official title: A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Trial Comparing QLC5508 Versus Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Have Progressed After Treatment With Novel Hormonal Agents (NHA).
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
700
Start Date
2026-06-20
Completion Date
2030-11-20
Last Updated
2026-06-08
Healthy Volunteers
No
Conditions
Interventions
QLC5508
2.0 mg/kg Q2W, administered as an IV infusion until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
Docetaxel
75 mg/m2 Q3W, administered as an IV infusion (up to 10 cycles)