Using high-intensity focused ultrasound to treat localized prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Intraoperative Hyperspectral Imaging to guide prostate cancer removal

  This study tests a hyperspectral imaging device during prostate surgery to see if it can help identify cancer at the edges of the removed tissue in men with localized prostate cancer.

  Recruiting University Hospital, Geneva · Geneva, Canton of Geneva · NCT07826858

• Focal Micro-boost Radiotherapy for Localized Prostate Cancer

  This study tests whether adding a small, targeted boost to MRI-visible prostate lesions during moderately hypofractionated radiotherapy can improve cancer control in men with localized intermediate- to high-risk prostate cancer.

  Recruiting Regina Elena Cancer Institute · Rome, Lazio · NCT07792993

• Sonablate HIFU Registry for Prostate Cancer and BPH

  This registry collects real-world data from men treated with Sonablate HIFU to see how well it works and how it affects urinary and sexual function over the long term.

  Recruiting Sonablate · Indianapolis, Indiana · NCT07757490

• Water IV: See if Aquablation helps localized prostate cancer patients choose active surveillance

  This trial tests whether Aquablation therapy can be as safe and effective as choosing active surveillance for men with localized prostate cancer who are considering surveillance instead of immediate treatment.

  Recruiting at 12 sites PROCEPT BioRobotics · Chandler, Arizona and 27 other locations · NCT07650448

• Whole-gland prostate dose boost versus SBRT alone for PSMA-staged localized and locally advanced prostate cancer

  We will test whether adding a whole-gland radiation boost (with brachytherapy or a stereotactic boost) improves cancer control compared with SBRT alone in men whose prostate cancer is confined to the prostate on PSMA PET.

  Recruiting Phase 2/3 Affidea Nu-med Center of Oncological DIagnostics and Therapy · Zamość, Lublin Voivodeship · NCT07426055

• Oxybutynin ER to help early urinary continence after robotic prostatectomy

  This trial will test whether taking a daily extended-release oxybutynin pill helps men regain urinary control sooner after robot-assisted prostate removal.

  Recruiting National Taiwan University Hospital · Taipei · NCT06966778

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.