Combining TURP with standard therapy for metastatic prostate cancer
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
This study is testing if combining a procedure to relieve urinary blockage with standard cancer treatments can help men with metastatic prostate cancer live longer and feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06655259 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 to 80 with newly diagnosed metastatic prostate cancer confirmed by imaging.
Not a fit: Patients with small cell or signet ring cell carcinoma histological features will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and quality of life for patients with metastatic prostate cancer.
How similar studies have performed: While combining surgical and systemic therapies is a common approach, this specific combination has not been extensively tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Dingwei Ye, MD.
- Email: dwyeli@163.com
- Phone: +862164175590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.