Combining TURP with standard therapy for metastatic prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II, open-label clinical study aims to evaluate the efficacy and safety of combining transurethral resection of the prostate (TURP) with standard systemic therapy in patients diagnosed with metastatic prostate cancer (mPCa). Participants will undergo TURP to alleviate urinary obstruction and reduce tumor burden, followed by androgen deprivation therapy (ADT) and second-generation anti-androgen agents like abiraterone or enzalutamide. The primary outcome measured will be radiographic progression-free survival (rPFS), while secondary outcomes will include overall survival, biochemical progression-free survival, PSA response rates, and quality of life assessments. The study plans to enroll 200 patients and will be conducted at Fudan University Cancer Hospital.

Why it matters

Who can join: the full rules

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).

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Dingwei Ye, MD.
• Email: dwyeli@163.com
• Phone: +862164175590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.