Clinical trial NCT06655259: Combination of TURP and Standard Systemic Therapy for MPCa
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Metastatic Prostate Cancer
Keywords: mPCa
TURP
ADT
rPFS
prognosis
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-arm, open-label, prospective Phase II clinical trial. The model focuses on evaluating the combination of TURP (Transurethral Resection of the Prostate) and standard systemic therapy in patients newly diagnosed with metastatic prostate cancer (mPCa). All participants will receive TURP followed by androgen deprivation therapy (ADT), and second-generation anti-androgens such as abiraterone or enzalutamide. The study aims to assess both the efficacy and safety of this combined approach, with radiographic progression-free survival (rPFS) as the primary outcome, and secondary outcomes including overall survival (OS), biochemical progression-free survival (bPFS), and PSA response. The trial is conducted at a single center with a targeted enrollment of 200 patients.
Primary purpose: TREATMENT

Brief 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 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).

Primary outcomes:
measure: Radiographic Progression-Free Survival (rPFS)
timeFrame: 2 years
measure: Urinary Symptom Relief Rate
timeFrame: 2 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 2 years
measure: Biochemical Progression-Free Survival (bPFS)
timeFrame: 2 years
measure: 3-, 6-Months PSA Response Rate
timeFrame: 3 and 6 months
measure: Quality of Life Assessment
timeFrame: Baseline, 3, 6, 12, and 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: