NCT06655259RecruitingPhase 2
Combination of TURP and Standard Systemic Therapy for MPCa
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
Source: ClinicalTrials.gov · Last updated 23 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 13 Oct 2024
- Start date
- 21 Sept 2024
- Primary completion date
- Sept 2026
- Lead sponsor
- Fudan University
- Diseases
- Prostate cancer
- NCT number
- NCT06655259
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 200
- From 21 Sept 2024 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Patients currently receiving any investigational drugs or devices.
Other illness
- 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.
- 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.
- Patients with active brain metastases or leptomeningeal disease.
- 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).
Other
- Patients with significant contraindications to TURP, such as severe urethral stricture or inability to catheterize.
- Patients who are unlikely to comply with the treatment protocol and follow-up schedule.
Who the study is looking for
- 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 0-1.
- 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.
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.