Combination of TURP and Standard Systemic Therapy for MPCa

Trial Title: Combination of TURP and Standard Systemic Therapy for MPCa

NCT ID: NCT06655259

Condition: Metastatic Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
mPCa
TURP
ADT
rPFS
prognosis

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

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

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: TURP
Description: Participants will undergo Transurethral Resection of the Prostate (TURP), a surgical procedure performed to relieve symptoms of urinary obstruction caused by the prostate tumor
Arm group label: TURP Combined with Standard Systemic Therapy

Intervention type: Drug
Intervention name: Standard Medical Therapy
Description: Participants will receive Standard Medical Therapy, which includes ADT, typically with an LHRH agonist or antagonist, to reduce testosterone levels, a key driver of prostate cancer progression. In addition to ADT, participants may be treated with second-generation anti-androgen drugs such as Abiraterone or Enzalutamide. These medications block androgen receptor signaling and further inhibit the cancer's ability to grow.
Arm group label: TURP Combined with Standard Systemic Therapy

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.

Criteria for 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).

Gender: Male

Gender based: Yes

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Fudan University Shanghai Cancer Center

Address:
City: Shanghai
Zip: 200032
Country: China

Status: Recruiting

Contact:
Last name: Dingwei Ye, MD.

Phone: 86-21-64175590
Email: dwyeli@163.com

Contact backup:
Last name: Xiaojian Qin, MD.

Phone: +86 18017317217
Email: q@urocancer.org

Contact backup:
Last name: Dingwei Ye, MD.

Start date: September 21, 2024

Completion date: December 2026

Lead sponsor:
Agency: Fudan University
Agency class: Other

Source: Fudan University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06655259