RecruitingNCT06362577

Clinical Study of HIFU for Localized Prostate Cancer

Post-marketing Clinical Study of Transrectal High-intensity Focused Ultrasound for Localized Prostate Cancer

Sponsor

RenJi Hospital

Enrollment

60 participants

Start Date

May 21, 2024

Study Type

OBSERVATIONAL

Conditions

Localized Prostate Cancer

Summary

In this study, the safety and effectiveness data of Sonablate system, a transrectal high-intensity focused ultrasound therapeutic instrument, in the treatment of localized prostate cancer were collected, and the treatment conditions of patients with other methods (such as radical prostatectomy) were compared and analyzed. Observe the differences in treatment effect, survival rate, postoperative PSA, recurrence and complications. To analyze and compare the clinical outcome, postoperative complications and tumor control of HIFU and robot-assisted laparoscopic radical prostatectomy for localized prostate cancer, and to explore the effectiveness and safety of HIFU in the treatment of localized prostate cancer, so as to provide an alternative treatment for localized prostate cancer.

Eligibility

Sex: MALEMin Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatments for localized (non-spreading) prostate cancer: high-intensity focused ultrasound (HIFU), which uses sound waves to destroy cancer cells without surgery, versus robot-assisted surgery to remove the prostate. **You may be eligible if...** - You are a man over 40 years old - You have localized prostate cancer confirmed by biopsy or MRI-guided biopsy - Your cancer has not spread to lymph nodes or other parts of the body - Your PSA level is below 20 ng/mL - Your cancer is low-to-intermediate risk (Gleason score 7 or below) **You may NOT be eligible if...** - You have an active urinary tract or genital infection - You have had prior prostate treatments - You have other conditions that would make you ineligible based on the treating doctor's assessment 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

DIAGNOSTIC_TESTEQ-5D-5L IPSS IIEF-5 EPIC-26 ECOG

Diagnostic Test were collected at before surgery, during surgery,2 months, 6 months, 9 months, 12 months, 18 months and 24 months after radical surgery

Locations(1)

Renji Hospital-Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

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NCT06362577

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