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NCT06362577Recruiting

Clinical Study of HIFU for Localized Prostate Cancer

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

Source: ClinicalTrials.gov · Last updated 15 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
60 (estimated)
First submitted
17 Mar 2024
Start date
21 May 2024
Primary completion date
30 Nov 2025
Lead sponsor
RenJi Hospital
NCT number
NCT06362577

What you commit to

  • Study type: Observational
  • Planned participants: 60
  • From 21 May 2024 to the primary completion date, 30 Nov 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • Either must be \"No\" or the patient cannot be enrolled.
    • The active stage accompanied by other genitourinary system infections 100 days before surgery;
    • Men who have previously received radiation therapy;
    • 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;
    • The presence of a metal implant/stent in the urethra;
    • 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;
    • 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).

Who the study is looking for

  • Men over the age of Forty;
  • Localized prostate cancer for which transperineal template prostate biopsy or MRI targeted biopsy combined with systematic biopsy is performed;
  • 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)

Age in the registry: 40 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Renji Hospital Shanghai Jiao Tong University School of Medicine
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.