An Open-Label, Prospective, Single-Arm Clinical, Phase II Study on the Efficacy and Safety of TURP Combined with Standard Systemic Therapy in Patients with Metastatic Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Radiographic Progression-Free Survival (rPFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients must voluntarily agree to participate and provide signed informed consent.
- •aged 18 to 80 years.
- •Pathologically or cytologically confirmed adenocarcinoma of the prostate, with neuroendocrine differentiation components ≤10%, and no small cell or signet ring cell carcinoma histological features.
- •Newly diagnosed metastatic prostate cancer with evidence of metastasis (lymph node, bone, or visceral metastases) confirmed by PSMA/PET-CT, CT, or MRI.
- •Patients must not have participated in or plan to participate in another clinical trial.
- •ECOG PS score of 0-
- •Adequate Organ and Bone Marrow Function:
- •Absolute neutrophil count (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.
- •Ⅴ. Kidney function: serum creatinine ≤ 2×ULN or calculated creatinine clearance ≥ 30 mL/min.
- •Ⅵ. Coagulation function: INR ≤ 1.5.
排除标准
- •History of hypersensitivity or intolerance to any of the drugs used in the study.
- •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.
- •Oligometastatic mHSPC Patients: Patients with oligometastatic hormone-sensitive prostate cancer (mHSPC) who are planning to undergo radical prostatectomy as the primary treatment.
- •Patients with significant contraindications to TURP, such as severe urethral stricture or inability to catheterize.
- •History of seizures or medications known to lower the seizure threshold, or any disease that may induce seizures (e.g., stroke or transient ischemic attacks) within 12 months prior to the study.
- •Recent Major Surgery: Patients who have undergone major surgery within 4 weeks before starting the study treatment.
- •History of severe or unstable cardiovascular disease within the last 6 months, including severe angina, myocardial infarction, congestive heart failure (NYHA III or higher), cerebrovascular accident, or requiring medication for arrhythmia.
- •Severe Digestive Disorders: Patients with chronic diarrhea, bowel obstruction, or other factors affecting drug absorption.
- •Patients with active infections, including HIV, hepatitis B (HBsAg-positive), or hepatitis C, that may affect the safety and efficacy of the treatment.
- •Patients diagnosed with other malignancies in the past 3 years, excluding cured basal cell carcinoma of the skin.
- •Patients with active brain metastases or leptomeningeal disease.
- •Patients currently receiving any investigational drugs or devices.
- •Patients who are unlikely to comply with the treatment protocol and follow-up schedule.
- •Any condition that the investigator believes could compromise the patient's safety or interfere with the study results (e.g., uncontrolled hypertension, severe diabetes, psychiatric conditions).
研究组 & 干预措施
TURP Combined with Standard Systemic Therapy
Participants in this arm will undergo Transurethral Resection of the Prostate (TURP) to alleviate urinary obstruction and reduce tumor burden, followed by Standard Systemic Therapy. This includes Androgen Deprivation Therapy (ADT) with either an LHRH agonist or antagonist, combined with a second-generation anti-androgen, such as abiraterone or enzalutamide, depending on the patient's condition. The goal is to assess the efficacy and safety of this combined approach in treating patients with metastatic prostate cancer (mPCa).
干预措施: TURP (Procedure)
TURP Combined with Standard Systemic Therapy
Participants in this arm will undergo Transurethral Resection of the Prostate (TURP) to alleviate urinary obstruction and reduce tumor burden, followed by Standard Systemic Therapy. This includes Androgen Deprivation Therapy (ADT) with either an LHRH agonist or antagonist, combined with a second-generation anti-androgen, such as abiraterone or enzalutamide, depending on the patient's condition. The goal is to assess the efficacy and safety of this combined approach in treating patients with metastatic prostate cancer (mPCa).
干预措施: Standard Medical Therapy (Drug)
结局指标
主要结局
Radiographic Progression-Free Survival (rPFS)
时间窗: 2 years
Defined as the time from the start of treatment to radiographic evidence of disease progression, assessed by imaging techniques such as PSMA PET-CT, MRI, or CT scans, following RECIST 1.1 criteria. The primary objective is to evaluate how long patients remain free from disease progression after receiving the combination of TURP and standard systemic therapy.
Urinary Symptom Relief Rate
时间窗: 2 years
Urinary symptom relief will be assessed using the International Prostate Symptom Score (IPSS) and objective measures like urine flow rate. The goal is to evaluate the extent to which TURP alleviates urinary obstruction and related symptoms in patients with metastatic prostate cancer.
次要结局
- Overall Survival (OS)(2 years)
- Biochemical Progression-Free Survival (bPFS)(2 years)
- 3-, 6-Months PSA Response Rate(3 and 6 months)
- Quality of Life Assessment(Baseline, 3, 6, 12, and 24 months)
研究者
Ding-Wei Ye
MD, Professor of Urology, Fudan University Cancer Hospital
Fudan University