Actively Recruiting
Post-marketing Clinical Study of Transrectal High-intensity Focused Ultrasound for Localized Prostate Cancer
Led by RenJi Hospital · Updated on 2024-08-15
60
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of the Sonablate system, a transrectal high-intensity focused ultrasound (HIFU) device, in treating localized prostate cancer. The study compares this treatment to robot-assisted laparoscopic radical prostatectomy (RALP) in terms of treatment outcomes, survival rates, postoperative PSA levels, cancer recurrence, and complications. The goal is to explore whether HIFU offers a safe and effective alternative treatment for localized prostate cancer. This observational study collects medical records and questionnaire data from patients treated with either HIFU or RALP at Renji Hospital. Patients are divided into two groups: one receiving HIFU therapy and the other undergoing RALP surgery. No additional medication is given as part of the study. Data collection includes diagnostic tests and questionnaires at multiple time points: before surgery, during surgery, and at 2, 6, 9, 12, 18, and 24 months after treatment. Participants will be monitored through medical history reviews, PSA level measurements, mp-MRI imaging, and quality of life assessments. Researchers will track postoperative complications, tumor control, biochemical recurrence, and survival rates over two years. Several validated questionnaires and diagnostic tools will be used to evaluate sexual function, urinary symptoms, and overall health status. The study follows patients both retrospectively and prospectively to better understand long-term outcomes and safety.
CONDITIONS
Brief Title
Clinical Study of HIFU for Localized Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men over the age of 40
- Diagnosed with localized prostate cancer confirmed by transperineal template prostate biopsy or MRI-targeted biopsy combined with systematic biopsy
- Disease stage Ti-T2cN0M0
- Serum PSA less than 20 ng/ml
- Gleason score 7 or lower (3+4 or 4+3 or lower)
- Evaluated medium-low risk prostate cancer within T2 stage without lymph node or distant metastasis
- Treatment with Sonablate� transrectal high intensity focused ultrasound (HIFU) or robot-assisted laparoscopic radical prostatectomy (RALP)
You will not qualify if you...
- Active genitourinary system infections within 100 days before surgery
- Previous radiation therapy
- Abnormal liver, heart, or kidney function prior to surgery (ALT, AST, or serum alkaline phosphatase levels above 3 times normal)
- Coagulation disorders
- History of other malignancies except basal cell or squamous skin carcinoma; malignancies not recurrent in last 5 years allowed
- Presence of metal implant or stent in the urethra
- Lesions located where treatment focus cannot be reached or acoustic channels blocked
- Considered unsuitable by investigator due to mental, emotional, hearing, speaking, reading, writing disorders, or poor compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment event
Participants undergo either high-intensity focused ultrasound (HIFU) therapy or robot-assisted laparoscopic radical prostatectomy (RALP) for localized prostate cancer. These treatments are performed as part of routine clinical care without additional intervention from the study.
1 visit (in-person) for treatment
Duration - Up to 24 months
Participants are followed after treatment with medical record review and completion of questionnaires assessing quality of life and sexual function. Diagnostic tests including PSA levels and imaging are performed to monitor treatment effects, complications, and recurrence.
Visits at 2, 6, 9, 12, 18, and 24 months post-treatment
Trial Site Locations
Total: 1 location
1
Renji Hospital-Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200001
Actively Recruiting
Research Team
W
Wang YanQing, Master's
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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