Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362577
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-03-17
Brief Title:
Clinical Study of HIFU for Localized Prostate Cancer
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
Study Overview
Official Title:
Post-marketing Clinical Study of Transrectal High-intensity Focused Ultrasound for Localized Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIFU
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
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 evaluatedIn 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 ngmL 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 andor prospective manners
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 evaluatedIn 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 ngmL 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 andor prospective manners
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None