Combination of TURP and Standard Systemic Therapy for MPCa (CTUSMEP01)

Fudan University

Status and phase: Enrolling; Phase 2

Conditions: Metastatic Prostate Cancer

Treatments: Procedure: TURP; Drug: Standard Medical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06655259

2409304-4

Details and patient eligibility

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.

Enrollment: 200 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must voluntarily agree to participate and provide signed informed consent.

2. aged 18 to 80 years.

3. Pathologically or cytologically confirmed adenocarcinoma of the prostate, with neuroendocrine differentiation components ≤10%, and no small cell or signet ring cell carcinoma histological features.

4. Newly diagnosed metastatic prostate cancer with evidence of metastasis (lymph node, bone, or visceral metastases) confirmed by PSMA/PET-CT, CT, or MRI.

5. Patients must not have participated in or plan to participate in another clinical trial.

6. ECOG PS score of 0-1.

7. 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.

Exclusion criteria

1. History of hypersensitivity or intolerance to any of the drugs used in the study.
2. 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.
3. Oligometastatic mHSPC Patients: Patients with oligometastatic hormone-sensitive prostate cancer (mHSPC) who are planning to undergo radical prostatectomy as the primary treatment.
4. Patients with significant contraindications to TURP, such as severe urethral stricture or inability to catheterize.
5. 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.
6. Recent Major Surgery: Patients who have undergone major surgery within 4 weeks before starting the study treatment.
7. 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.
8. Severe Digestive Disorders: Patients with chronic diarrhea, bowel obstruction, or other factors affecting drug absorption.
9. Patients with active infections, including HIV, hepatitis B (HBsAg-positive), or hepatitis C, that may affect the safety and efficacy of the treatment.
10. Patients diagnosed with other malignancies in the past 3 years, excluding cured basal cell carcinoma of the skin.
11. Patients with active brain metastases or leptomeningeal disease.
12. Patients currently receiving any investigational drugs or devices.
13. Patients who are unlikely to comply with the treatment protocol and follow-up schedule.
14. 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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

TURP Combined with Standard Systemic Therapy

Experimental group

Description:

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).

Treatment:

Drug: Standard Medical Therapy

Procedure: TURP