Clinical trial NCT06362577: Clinical Study of HIFU for Localized Prostate Cancer
Official title: Post-marketing Clinical Study of Transrectal High-intensity Focused Ultrasound for Localized Prostate Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Localized Prostate Cancer
Keywords: HIFU
Localized prostate cancer
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 60
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medium-and low-risk prostate cancer patients without lymph node and distant metastasis within T2 period. Patients diagnosed with prostate cancer by histology or cytology; Combined with her clinical symptoms, digital rectal examination, serum prostate-specific antigen (PSA), and local imaging, it was confirmed pathologically through prostate biopsy.

Brief summary: 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.

Detailed description: This observational study will collect medical history and questionnaire data before and after high intensity focused ultrasound (HIFU) or radical surgery to perform local ablation or excision of prostate cancer tissue.

This study established a cohort of relevant subjects and collected their postoperative follow-up data. The study was divided into two groups:

* Study group: Transrectal high intensity focused ultrasound (HIFU) therapy;
* Control group: robot-assisted laparoscopic radical prostatectomy (RALP). Compare and analyze the treatment status of the same period of patients treated by the study group or the control group, observe the differences in treatment effect, survival rate, postoperative PSA, recurrence and complications, and explore the effectiveness and safety of HIFU treatment for localized prostate cancer.

Electronic medical records of prostate cancer patients who received Sonablate® high intensity focused ultrasound (HIFU) and robot-assisted laparoscopic radical prostatectomy at Renji Hospital, Shanghai Jiao Tong University School of Medicine from 2021 to the end of the study were collected and analyzed. Baseline characteristics, postoperative complications and disease control rate were evaluated.In this study, patients clinically diagnosed with localized prostate cancer were classified into low - and medium-risk groups to receive local HIFU treatment or robot-assisted laparoscopic radical prostatectomy (RALP) from March 2021 to the end of the study through medical history review. Patient age, PSA value at the time of diagnosis of prostate cancer, and whether they received short-term antiandrogen therapy before treatment were collected. The changes of PSA levels in each group were dynamically observed after surgery, mp-MRI was performed under the guidance of ultrasound-guided, and the negative rate was calculated. Phoenix was defined as biochemical recurrence (PSA ≥2 ng/mL higher than the lowest point), and the patient experience (postoperative complications and quality of life) after HIFU and robot-assisted laparoscopic radical prostatic resection were compared. Write clinical evaluation report.

Patients meeting the inclusion criteria were divided into the control group \[receiving robot-assisted laparoscopic radical prostatectomy (RALP)\] and the study group \[receiving high-intensity focused ultrasound (HIFU)\]. A cohort of relevant patients was established and postoperative follow-up data were collected. The relevant outcome indicators and clinical indicators before and after treatment were compared between the two groups. To clarify the clinical value of high-intensity focused ultrasound in local treatment of localized prostate cancer, and further explore the related prognostic factors.

Subjects will be included in this study in a combination of retrospective and/or prospective manners.

Eligibility 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 \&amp;lt; 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 \&amp;#34;No\&amp;#34; 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).

Primary outcomes:
measure: Incidence of postoperative complications
timeFrame: before surgery, during surgery,2 months, 6 months, 9 months, 12 months, 18 months and 24 months after radical surgery
Secondary outcomes:
measure: Prostate-specific antigen (PSA), PSA levels at 1 month, 3 months, and 6 months after surgery
timeFrame: before surgery, during surgery,1 months, 3months, 6 months after surgery,
measure: Assessment of quality of life and sexual function spontaneously reported at 2, 6, and 12 months after surgery
timeFrame: before surgery, during surgery,2 months, 6 months, 9 months, 12 months, 18 months and 24 months after radical surgery
measure: The incidence of imaging recurrence that requires remedial or systemic treatment 12 months after surgery
timeFrame: before surgery, during surgery, 6 months, 12 months after surgery
measure: Failure-free survival (FFS) at 6 and 12 months postoperatively
timeFrame: before surgery, during surgery, 6 months, 12 months after surgery
measure: Postoperative overall survival rate
timeFrame: before surgery, during surgery,2 months, 6 months, 9 months, 12 months, 18 months and 24 months after radical surgery
measure: Overall postoperative complication rate
timeFrame: before surgery, during surgery,2 months, 6 months, 9 months, 12 months, 18 months and 24 months after radical surgery
measure: Number of device defects
timeFrame: before surgery, during surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital-Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Xue Wei, Doctor's
role: PRINCIPAL_INVESTIGATOR
References: