Combination of TURP and Standard Systemic Therapy for MPCa

NCT ID: NCT06655259

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-21
• Study Completion Date: 2026-12-31

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.

Conditions

Metastatic Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TURP Combined with Standard Systemic Therapy

Participants in this arm will undergo Transurethral Resection of the Prostate (TURP) to alleviate urinary obstruction and reduce tumor burden, followed by Standard Systemic Therapy. This includes Androgen Deprivation Therapy (ADT) with either an LHRH agonist or antagonist, combined with a second-generation anti-androgen, such as abiraterone or enzalutamide, depending on the patient's condition. The goal is to assess the efficacy and safety of this combined approach in treating patients with metastatic prostate cancer (mPCa).

Group Type: EXPERIMENTAL

TURP

Intervention Type: PROCEDURE

Participants will undergo Transurethral Resection of the Prostate (TURP), a surgical procedure performed to relieve symptoms of urinary obstruction caused by the prostate tumor

Standard Medical Therapy

Intervention Type: DRUG

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.

Interventions

TURP

Participants will undergo Transurethral Resection of the Prostate (TURP), a surgical procedure performed to relieve symptoms of urinary obstruction caused by the prostate tumor

Intervention Type: PROCEDURE

Standard Medical Therapy

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.

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Ding-Wei Ye

MD, Professor of Urology, Fudan University Cancer Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Dingwei Ye, MD.

Role: CONTACT

dwyeli@163.com

+862164175590

Xiaojian Qin, MD.

Role: CONTACT

q@urocancer.org

+86 18017317217

Facility Contacts

Dingwei Ye, MD.

Role: primary

dwyeli@163.com

86-21-64175590

Xiaojian Qin, MD.

Role: backup

q@urocancer.org

+86 18017317217

Dingwei Ye, MD.

Role: backup

Other Identifiers

2409304-4

Identifier Type: -

Identifier Source: org_study_id