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
Overview
- Phase
- Phase 2
- Intervention
- TURP
- Conditions
- Metastatic Prostate Cancer
- Sponsor
- Fudan University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Radiographic Progression-Free Survival (rPFS)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Ding-Wei Ye
MD, Professor of Urology, Fudan University Cancer Hospital
Fudan University
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Arms & Interventions
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).
Intervention: TURP
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).
Intervention: Standard Medical Therapy
Outcomes
Primary Outcomes
Radiographic Progression-Free Survival (rPFS)
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)