Actively Recruiting
Clinical Study of HIFU for Localized Prostate Cancer
Led by RenJi Hospital · Updated on 2024-08-15
60
Participants Needed
1
Research Sites
136 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Study of HIFU for Localized Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men over the age of Forty
- 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)
- Medium-low risk prostate cancer within T2 stage without lymph node or distant metastasis as evaluated by the researcher
- 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 renal, heart, or liver function before surgery defined as ALT, AST, or serum alkaline phosphatase levels above three times the upper normal limit
- Coagulation disorders
- History of other malignancies except basal cell carcinoma or squamous skin carcinoma; malignancies without recurrence in the last 5 years are allowed
- Presence of a metal implant or stent in the urethra
- Lesions located at the anterior tip of the prostate or in front of the urethra or other locations unreachable by HIFU or blocked acoustic channels
- Considered unsuitable to participate due to mental, emotional, or communication disorders or poor compliance
AI-Screening
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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
CONTACT
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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