Clinical Study of HIFU for Localized Prostate Cancer

Localized Prostate Cancer Clinical Trial

— HIFU  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06362577
• Other study ID #: TSC202202
• Status: Not yet recruiting
• Start date: April 15, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: RenJi Hospital
• Contact: Wang YanQing, Master's
• Phone: 13917826792
• Email: iwangyq[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Localized Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• EQ-5D-5L IPSS IIEF-5 EPIC-26 ECOG
Diagnostic Test were collected at before surgery, during surgery,2 months, 6 months, 9 months, 12 months, 18 months and 24 months after radical surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative complications	The data were collected through medical records inquiry, consultation and questionnaire	before surgery, during surgery,2 months, 6 months, 9 months, 12 months, 18 months and 24 months after radical surgery
Secondary	The time to reach the lowest point of PSA	The lowest PSA data was obtained by collecting PSA data at each postoperative time window	before surgery, during surgery,2 months, 6 months, 9 months, 12 months, 18 months and 24 months after radical surgery
Secondary	Assessment of quality of life and sexual function spontaneously reported at 2, 6, and 12 months after surgery	The first indicator was erectile dysfunction, which was statistically analyzed by the three degrees of mild, moderate and severe, and evaluated by collecting the IIEF-5 scale. The score of 5-7 was severe, 8-11 was moderate, and 12-21 was mild.The second is the health description system, which describes five dimensions: mobility (mobility), Self-Care (self-care), Usual Activities (Usual Activities), Pain or discomfort (Pain/comfort), Anxiety or Depression (Anxiety/Depression), each dimension contains five levels: No difficulty, some difficulty, moderate difficulty, severe difficulty, unable to proceed/have very serious difficulty	before surgery, during surgery,2 months, 6 months, 9 months, 12 months, 18 months and 24 months after radical surgery
Secondary	The negative rate of tumor exclusion was evaluated by imaging (mainly mp-MRI) at 2 and 12 months after surgery	The negative rate of tumor exclusion was assessed by collecting imaging reports (mainly mp-MRI) at 2 to 12 months after surgery	before surgery, during surgery,2 months, 6 months, 9 months, 12 months and 18 months after radical surgery
Secondary	The incidence of biochemical recurrence that requires remedial or systemic treatment 12 months after surgery	By collecting PSA data within 12 months after surgery, the incidence of biochemical recurrence progressing to remedial or systemic treatment was calculated.	before surgery, during surgery,2 months, 6 months, 9 months, 12 months and 18 months after radical surgery
Secondary	Postoperative overall survival rate	Overall survival rates were collected up to 24 months after surgery.	before surgery, during surgery,2 months, 6 months, 9 months, 12 months, 18 months and 24 months after radical surgery