Combination of TURP and Standard Systemic Therapy for MPCa

Официальное название

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

Обзор

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.

Вмешательства

• Процедура TURP
  Participants will undergo Transurethral Resection of the Prostate (TURP), a surgical procedure performed to relieve symptoms of urinary obstruction caused by the prostate tumor
• Препарат Standard Medical Therapy
  Participants will receive Standard Medical Therapy, which includes ADT, typically with an LHRH agonist or antagonist, to reduce testosterone levels, a key driver of prostate cancer progression. In addition to ADT, participants may be treated with second-generation anti-androgen drugs such as Abiraterone or Enzalutamide. These medications block androgen receptor signaling and further inhibit the cancer\'s ability to grow.

Первичные конечные точки

• Radiographic Progression-Free Survival (rPFS) [Срок оценки: 2 years]
• Urinary Symptom Relief Rate [Срок оценки: 2 years]

Вторичные конечные точки (4)

• Overall Survival (OS) [Срок оценки: 2 years]
• Biochemical Progression-Free Survival (bPFS) [Срок оценки: 2 years]
• 3-, 6-Months PSA Response Rate [Срок оценки: 3 and 6 months]
• Quality of Life Assessment [Срок оценки: Baseline, 3, 6, 12, and 24 months]

Критерии участия

Критерии включения

• 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 0-1.
• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT06655259 · 2409304-4

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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