Actively Recruiting

Phase 2
Age: 18Years - 80Years
MALE
NCT06655259

Combination of TURP and Standard Systemic Therapy for MPCa

Led by Fudan University · Updated on 2024-10-23

200

Participants Needed

1

Research Sites

114 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Combination of TURP and Standard Systemic Therapy for MPCa

Who Can Participate

Age: 18Years - 80Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must voluntarily agree to participate and provide signed informed consent.
  • Age between 18 and 80 years.
  • Pathologically or cytologically confirmed prostate adenocarcinoma with neuroendocrine differentiation �3C=10%, excluding small cell or signet ring cell carcinoma.
  • Newly diagnosed metastatic prostate cancer with metastasis confirmed by PSMA/PET-CT, CT, or MRI.
  • No participation in other clinical trials.
  • ECOG performance status score of 0-1.
  • Adequate organ and bone marrow function including neutrophil count �3E=1500/bcL, hemoglobin �3E=9.0 g/dL, platelet count �3E=100,000/bcL.
  • Liver function: total bilirubin �3C=1.5x upper limit normal (ULN), AST/ALT and alkaline phosphatase �3C=2.5x ULN.
  • Kidney function: serum creatinine �3C=2x ULN or creatinine clearance �3E=30 mL/min.
  • Coagulation function: INR �3C=1.5.
Not Eligible

You will not qualify if you...

  • History of hypersensitivity or intolerance to study drugs.
  • Diagnosed with metastatic castration-resistant prostate cancer who had TURP without urinary obstruction or hematuria.
  • Oligometastatic hormone-sensitive prostate cancer patients planning radical prostatectomy.
  • Significant contraindications to TURP such as severe urethral stricture or inability to catheterize.
  • History of seizures, use of seizure-lowering medications, or diseases causing seizures within the last 12 months.
  • Major surgery within 4 weeks before study treatment.
  • Severe or unstable cardiovascular disease within 6 months (including severe angina, myocardial infarction, heart failure NYHA III or higher, cerebrovascular accident, arrhythmia requiring medication).
  • Severe digestive disorders affecting drug absorption.
  • Active infections including HIV, hepatitis B, or hepatitis C.
  • Other malignancies in past 3 years except cured basal cell skin carcinoma.
  • Active brain metastases or leptomeningeal disease.
  • Current use of investigational drugs or devices.
  • Likely non-compliance with treatment or follow-up.
  • Any condition compromising safety or study results (e.g., uncontrolled hypertension, severe diabetes, psychiatric conditions).

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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Research Team

D

Dingwei Ye, MD.

CONTACT

X

Xiaojian Qin, MD.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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