Clinical Study of HIFU for Localized Prostate Cancer

NCT06362577 | Recruiting

• 1 other identifier: TSC202202
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Localized Prostate Cancer

Keywords

HIFU; Localized prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Prostate-specific antigen (PSA), PSA levels at 1 month, 3 months, and 6 months after surgery

  before surgery, during surgery,1 months, 3months, 6 months after surgery,

• Assessment of quality of life and sexual function spontaneously reported at 2, 6, and 12 months after surgery

  before surgery, during surgery,2 months, 6 months, 9 months, 12 months, 18 months and 24 months after radical surgery

• The incidence of imaging recurrence that requires remedial or systemic treatment 12 months after surgery

  before surgery, during surgery, 6 months, 12 months after surgery

• Failure-free survival (FFS) at 6 and 12 months postoperatively

  before surgery, during surgery, 6 months, 12 months after surgery

• Postoperative overall survival rate

  before surgery, during surgery,2 months, 6 months, 9 months, 12 months, 18 months and 24 months after radical surgery

Study Arms (2)

high-intensity focused ultrasound.

Medical records and questionnaire data will be collected from patients with localized prostate cancer treated with Sonablate® high intensity focused ultrasound (HIFU) and robot-assisted laparoscopic radical prostatectomy (RALP) at Renji Hospital, Shanghai Jiao Tong University School of Medicine from 2021 to 2023 for local ablation or resection. And make a summary analysis.Patients with localized prostate cancer treated by high-intensity focused ultrasound.This Group Have No intervention.These do not require medication。EQ-5D-5L IPSS IIEF-5 EPIC-26 ECOG Diagnostic Tests were collected at before surgery, during surgery,2 months, 6 months, 9 months, 12 months, 18 months and 24 months after patients with localized prostate cancer treated with Sonablate® high intensity focused ultrasound (HIFU) .

Diagnostic Test: EQ-5D-5L IPSS IIEF-5 EPIC-26 ECOG

robot-assisted laparoscopic radical prostatectomy

Medical records and questionnaire data will be collected from patients with localized prostate cancer treated with Sonablate® high intensity focused ultrasound (HIFU) and robot-assisted laparoscopic radical prostatectomy (RALP) at Renji Hospital, Shanghai Jiao Tong University School of Medicine from 2021 to 2023 for local ablation or resection. And make a summary analysis.Patients with localized prostate cancer treated by robot-assisted laparoscopic radical prostatectomy (RALP)。This Group Have No intervention.These do not require medication。EQ-5D-5L IPSS IIEF-5 EPIC-26 ECOG Diagnostic Tests were collected at before surgery, during surgery,2 months, 6 months, 9 months, 12 months, 18 months and 24 months after patients with localized prostate cancer treated with robot-assisted laparoscopic radical prostatectomy (RALP) .

Diagnostic Test: EQ-5D-5L IPSS IIEF-5 EPIC-26 ECOG

Interventions

EQ-5D-5L IPSS IIEF-5 EPIC-26 ECOG DIAGNOSTIC_TEST

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

high-intensity focused ultrasound.; robot-assisted laparoscopic radical prostatectomy

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: The study involved only male patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital-Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200001, China

RECRUITING

Study Officials

• Xue Wei, Doctor's

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang YanQing, Master's

CONTACT

13917826792; iwangyq@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: April 12, 2024
• Study Start: May 21, 2024
• Primary Completion: November 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The first case is enrolled until the Study report is completed
• Access Criteria: All the data in the project is available to the shared person.

Locations

CN (1)