Using high-intensity focused ultrasound to treat localized prostate cancer
Post-marketing Clinical Study of Transrectal High-intensity Focused Ultrasound for Localized Prostate Cancer
RenJi Hospital · NCT06362577
This study is testing a new ultrasound treatment for localized prostate cancer to see if it works as well as surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 40 Years and up |
| Sex | Male |
| Sponsor | RenJi Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06362577 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety and effectiveness of the Sonablate system, a transrectal high-intensity focused ultrasound (HIFU) device, in treating localized prostate cancer. It compares outcomes between patients receiving HIFU and those undergoing robot-assisted laparoscopic radical prostatectomy (RALP). Data on treatment effects, survival rates, postoperative PSA levels, recurrence, and complications will be collected and analyzed. The goal is to provide insights into the effectiveness and safety of HIFU as an alternative treatment option for localized prostate cancer.
Who should consider this trial
Good fit: Ideal candidates are men over 40 with localized prostate cancer classified as Ti-T2cN0M0 and a Gleason score of 7 or lower.
Not a fit: Patients with active genitourinary infections, prior radiation therapy, or significant renal, heart, or liver abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a less invasive treatment option for localized prostate cancer with potentially fewer complications.
How similar studies have performed: Previous studies have shown promising results with HIFU for localized prostate cancer, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Men over the age of Forty; 2. Localized prostate cancer for which transperineal template prostate biopsy or MRI targeted biopsy combined with systematic biopsy is performed; 3. Ti-T2cN0M0 disease stage; Serum psa \< 20 ng/ml; Gleason score ≤7(3+4 or 4+3 or lower); Or the researcher evaluates the medium-low risk prostate cancer within T2 stage without lymph node and distant metastasis; Treatment was performed using Sonablate® transrectal high intensity focused ultrasound (HIFU) or robot-assisted laparoscopic radical prostatectomy (RALP) Exclusion Criteria: * Either must be \"No\" or the patient cannot be enrolled. 1. The active stage accompanied by other genitourinary system infections 100 days before surgery; 2. Men who have previously received radiation therapy; 3. Laboratory-assessed abnormalities of renal function in the heart and liver prior to surgical treatment: ALT, AST, or serum alkaline phosphatase levels above the upper limit of 3-fold normal, coagulation disorders, other malignancies (history of other malignancies other than basal cell carcinoma or squamous skin carcinoma. Patients with a pre-operative history of malignancy that has not recurred in the last 5 years (superficial bladder cancer normally clears in 2 years) are permitted; 4. The presence of a metal implant/stent in the urethra; 5. Patients whose lesions were located at the anterior tip of the prostate and in front of the urethra, and other locations where the focus could not be reached or the acoustic channels were blocked by important organs; 6. Those who were considered by the investigator to be unsuitable to participate in this clinical trial (such as patients with mental or emotional problems, patients with hearing, speaking, reading, and writing disorders, and poor compliance).
Where this trial is running
Shanghai, Shanghai Municipality
- Renji Hospital-Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Principal investigator: Xue Wei, Doctor's — RenJi Hospital
- Study coordinator: Wang YanQing, Master's
- Email: iwangyq@163.com
- Phone: 13917826792
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Localized Prostate Cancer, HIFU, Localized prostate cancer