Combination of TURP and Standard Systemic Therapy for MPCa

Last updated: October 21, 2024
Sponsor: Fudan University
Overall Status: Active - Recruiting

Phase

2

Condition

Prostate Cancer

Metastatic Cancer

Urologic Cancer

Treatment

TURP

Standard Medical Therapy

Clinical Study ID

NCT06655259
2409304-4
  • Ages 18-80
  • Male

Study 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.

Eligibility Criteria

Inclusion

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, withneuroendocrine differentiation components ≤10%, and no small cell or signet ringcell 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 clinicaltrial.

  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 alkalinephosphatase ≤ 2.5×ULN. Ⅴ. Kidney function: serum creatinine ≤ 2×ULN or calculatedcreatinine clearance ≥ 30 mL/min. Ⅵ. Coagulation function: INR ≤ 1.5.

Exclusion

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) whohave already undergone TURP and do not present with lower urinary tract obstructionor hematuria.

  3. Oligometastatic mHSPC Patients: Patients with oligometastatic hormone-sensitiveprostate cancer (mHSPC) who are planning to undergo radical prostatectomy as theprimary treatment.

  4. Patients with significant contraindications to TURP, such as severe urethralstricture or inability to catheterize.

  5. History of seizures or medications known to lower the seizure threshold, or anydisease 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 weeksbefore 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 IIIor higher), cerebrovascular accident, or requiring medication for arrhythmia.

  8. Severe Digestive Disorders: Patients with chronic diarrhea, bowel obstruction, orother factors affecting drug absorption.

  9. Patients with active infections, including HIV, hepatitis B (HBsAg-positive), orhepatitis C, that may affect the safety and efficacy of the treatment.

  10. Patients diagnosed with other malignancies in the past 3 years, excluding curedbasal 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-upschedule.

  14. Any condition that the investigator believes could compromise the patient's safetyor interfere with the study results (e.g., uncontrolled hypertension, severediabetes, psychiatric conditions).

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: TURP
Phase: 2
Study Start date:
September 21, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

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