RecruitingPhase 2NCT06655259

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

Sponsor

Fudan University

Enrollment

200 participants

Start Date

Sep 21, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Prostate Cancer

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

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a surgical procedure called TURP (a minimally invasive procedure to remove prostate tissue through the urethra) to standard drug therapy improves outcomes in men with newly diagnosed metastatic prostate cancer. **You may be eligible if...** - You are between 18 and 80 years old - You have newly diagnosed metastatic prostate cancer confirmed by biopsy - You are newly starting treatment (not yet on systemic therapy) - Your prostate cancer is the standard type (adenocarcinoma), not small cell or other rare variants **You may NOT be eligible if...** - You have already started systemic treatment for prostate cancer - Your cancer has a rare histological type (small cell, signet ring, etc.) - You have conditions that make surgery unsafe - You are outside the 18–80 age range Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETURP

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

DRUGStandard 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.

Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06655259

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