OncoMatch/Clinical Trials/NCT06655259
Combination of TURP and Standard Systemic Therapy for MPCa
Is NCT06655259 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Standard Medical Therapy for metastatic prostate cancer.
Treatment: Standard Medical Therapy — This is a Phase II, open-label, prospective, single-arm clinical study designed to evaluate the efficacy and safety of combining transurethral resection of the prostate (TURP) with standard systemic therapy in patients with metastatic prostate cancer (mPCa). All participants will undergo TURP to relieve urinary obstruction and reduce tumor burden, followed by androgen deprivation therapy (ADT) and second-generation anti-androgen agents, such as abiraterone or enzalutamide. The primary outcome is radiographic progression-free survival (rPFS), with secondary outcomes including overall survival (OS), biochemical progression-free survival (bPFS), PSA response rates at 3 and 6 months, and quality of life assessments. The trial will enroll 200 newly diagnosed metastatic prostate cancer patients, with regular follow-up for monitoring disease progression and treatment safety. The study will be conducted at Fudan University Cancer Hospital.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage IV
Metastatic disease required
Newly diagnosed metastatic prostate cancer with evidence of metastasis (lymph node, bone, or visceral metastases) confirmed by PSMA/PET-CT, CT, or MRI.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: transurethral resection of the prostate (TURP)
Exception: only if mCRPC and no lower urinary tract obstruction or hematuria
Patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC) who have already undergone TURP and do not present with lower urinary tract obstruction or hematuria.
Cannot have received: major surgery
Exception: within 4 weeks before starting the study treatment
Patients who have undergone major surgery within 4 weeks before starting the study treatment.
Lab requirements
Blood counts
ANC ≥ 1.5×10⁹/L (1500/μL); Hemoglobin ≥ 90 g/L (9.0 g/dL); Platelet count ≥ 80×10⁹/L (100,000/μL)
Kidney function
serum creatinine ≤ 2×ULN or calculated creatinine clearance ≥ 30 mL/min
Liver function
total bilirubin ≤ 1.5×ULN, AST/ALT and alkaline phosphatase ≤ 2.5×ULN
Adequate Organ and Bone Marrow Function: ANC ≥ 1.5×10⁹/L (1500/μL); Hemoglobin ≥ 90 g/L (9.0 g/dL); Platelet count ≥ 80×10⁹/L (100,000/μL); Liver function: total bilirubin ≤ 1.5×ULN, AST/ALT and alkaline phosphatase ≤ 2.5×ULN; Kidney function: serum creatinine ≤ 2×ULN or calculated creatinine clearance ≥ 30 mL/min; Coagulation function: INR ≤ 1.5.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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