Prostate cancer
Conditions
Interventions
cohort A:QL1706+Lenvatinib
cohort B:QL1706+Lenvatinib+Cyclophosphamide
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
Male
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Histologically/Cytologically Confirmed Prostate Adenocarcinoma * Pure adenocarcinoma without small cell neuroendocrine components. 2. Age >= 18 years. 3. ECOG Performance Status 0–2. 4. Life Expectancy >3 months. 5. Surgical/Chemical Castration Status * Bilateral orchiectomy and/or ongoing androgen deprivation therapy with serum testosterone = 1 novel androgen receptor inhibitor (e.g., enzalutamide, abiraterone). * Received >= 2 cycles of taxane-based chemotherapy (e.g., docetaxel). 7. mCRPC Diagnosis (Per PCWG3 Criteria) * Confirmed by >= 1 of: * PSA progression: >= 2 consecutive rises (>= 1 week apart) from baseline, with minimum value >= 2.0 ng/mL. * Soft-tissue progression: >= 20% increase in sum of target lesion diameters (RECIST 1.1). * Bone progression: New lesions on bone scan (2+2 rule). 8. Measurable Disease * >= 1 metastatic lesion confirmed by CT/MRI/bone scan within 28 days prior to enrollment. 9. Organ Function Requirements * Hematological: * WBC >= 3×10^9/L or ANC >= 1.5×10^9/L * Platelets >= 100×10^9/L * Hemoglobin >= 9 g/dL * Hepatic: * Total bilirubin = 50 mL/min * Albumin >3.0 g/dL 10. Recovery from Prior Toxicity * All treatment-related adverse events resolved to Grade <= 2 (per CTCAE v5.0).
Exclusion criteria
Exclusion criteria: 1. Prior Therapies * Anti-angiogenic agents (e.g., bevacizumab, cabozantinib) or immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1/CTLA-4). 2. Allergy * Known hypersensitivity to any component of the study drugs. 3. CNS Metastases * History of untreated or symptomatic brain metastases. Note: Treated and stable CNS lesions (confirmed by MRI/CT) without corticosteroid dependence are allowed. 4. Spinal Cord Compression * Symptomatic cord compression or impending compression requiring urgent intervention. 5. Comorbidities * NYHA Class III/IV heart failure, congenital long QT syndrome, uncontrolled infections, active HBV/HCV (unless on antiviral therapy), or other conditions deemed by the investigator to compromise study participation. 6. Concurrent Malignancy * Other active malignancies except: * Adequately treated non-melanoma skin cancer/superficial bladder cancer. * Malignancies with >3-year disease-free survival.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| radiographic progression-free survival (rPFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| PSA response rate;Time to PSA progression;Overall survival;Objective response rate;Clinical benefit rate; | — |
Countries
China
Contacts
Public ContactYanxia Shi
Sun Yat-sen University Cancer Center
Outcome results
None listed