QLC5508 in Participants With Metastatic Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QLC5508, Docetaxel.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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).
Overview
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).
Interventions
- Drug QLC5508
2.0 mg/kg Q2W, administered as an IV infusion until disease progression, unacceptable adverse events (AEs), or other cessation of treatment - Drug Docetaxel
75 mg/m2 Q3W, administered as an IV infusion (up to 10 cycles)
Primary outcome measures
- Radiographic Progression Free Survival (rPFS) [Time frame: Up to approximately 36 months]
Secondary outcome measures (6)
- Overall Survival (OS) [Time frame: Up to approximately 36 months]
- Objective Response Rate (ORR) [Time frame: Up to approximately 36 months]
- Prostate-specific Antigen (PSA) Response Rate [Time frame: Up to approximately 36 months]
- Time to Prostate-specific Antigen (PSA) Progression [Time frame: Up to approximately 36 months]
- Time to Pain Progression (TTPP) [Time frame: Up to approximately 36 months]
- Number of Participants Who Experienced at Least One Adverse Event (AE) [Time frame: Up to approximately 36 months]
Eligibility criteria
Inclusion criteria
- Male, aged ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 3 months.
- Histologically or cytologically confirmed adenocarcinoma of the prostate without evidence of small-cell features.
- Diagnosis of metastatic castration-resistant prostate cancer (mCRPC).
- Prior treatment with novel hormonal agents (NHAs) and documented disease progression.
- Adequate organ function.
- Recovery from all reversible adverse events (AEs) related to prior anticancer therapies.
Exclusion criteria
- 1\. Prior treatment with a B7-H3-targeted therapy, or with an antibody-drug conjugate (ADC) using a topoisomerase I inhibitor (TOP1i) as the payload, or with any TOP1i-class agent.
2\. History of or current significant cardiovascular or cerebrovascular disease. 3. Active, uncontrolled infection. 4. Concurrent or prior history of another primary malignancy 5. History of interstitial lung disease (ILD) or non-infectious pneumonitis, or current ILD/non-infectious pneumonitis 6. Current hepatic encephalopathy, hepatorenal syndrome, or cirrhosis classified as Child-Pugh class B or worse.
7\. Known hypersensitivity or allergy to any investigational product or its excipients.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07632690 · QLC5508-302