Combination of TURP and Standard Systemic Therapy for MPCa

NCT06655259 | Recruiting Phase 2 DMC

• 1 other identifier: 2409304-4
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

mPCa; TURP; ADT; rPFS; prognosis

Outcome Measures

Primary Outcomes (2)

• Radiographic Progression-Free Survival (rPFS)

  Defined as the time from the start of treatment to radiographic evidence of disease progression, assessed by imaging techniques such as PSMA PET-CT, MRI, or CT scans, following RECIST 1.1 criteria. The primary objective is to evaluate how long patients remain free from disease progression after receiving the combination of TURP and standard systemic therapy.

  2 years

• Urinary Symptom Relief Rate

  Urinary symptom relief will be assessed using the International Prostate Symptom Score (IPSS) and objective measures like urine flow rate. The goal is to evaluate the extent to which TURP alleviates urinary obstruction and related symptoms in patients with metastatic prostate cancer.

  2 years

Secondary Outcomes (4)

• Overall Survival (OS)

  2 years

• Biochemical Progression-Free Survival (bPFS)

  2 years

• 3-, 6-Months PSA Response Rate

  3 and 6 months

• Quality of Life Assessment

  Baseline, 3, 6, 12, and 24 months

Study Arms (1)

TURP Combined with Standard Systemic Therapy

EXPERIMENTAL

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).

Procedure: TURP; Drug: Standard Medical Therapy

Interventions

TURP 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

TURP Combined with Standard Systemic Therapy

Standard Medical Therapy 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.

TURP Combined with Standard Systemic Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients with significant contraindications to TURP, such as severe urethral stricture or inability to catheterize.
• 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.
• 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.
• Patients currently receiving any investigational drugs or devices.
• Patients who are unlikely to comply with the treatment protocol and follow-up schedule.
• 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).

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Dingwei Ye, MD.

CONTACT

+862164175590; dwyeli@163.com

Xiaojian Qin, MD.

CONTACT

+86 18017317217; q@urocancer.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor of Urology, Fudan University Cancer Hospital

Model Details: 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.

Study Record Dates

• First Submitted: October 13, 2024
• First Posted: October 23, 2024
• Study Start: September 21, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 23, 2024

Record last verified: 2024-10

Locations

CN (1)