An observational study in Localized Prostate Cancer, sponsored by RenJi Hospital. Recruiting at 1 site in China. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by RenJi Hospital · Observational
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.
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:
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 60 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
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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.
Exclusion Criteria:
Either must be \"No\" or the patient cannot be enrolled.
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
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
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
Incidence of postoperative complications
The data were collected through medical records inquiry, consultation and questionnaire
Time frame: before surgery, during surgery,2 months, 6 months, 9 months, 12 months, 18 months and 24 months after radical surgery
Prostate-specific antigen (PSA), PSA levels at 1 month, 3 months, and 6 months after surgery
The PSA data was obtained by collecting postoperative PSA data at 1 month, 3 months, and 6 months.
Time frame: 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
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
Time frame: 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
By collecting PSA data within 12 months after surgery, the incidence of imaging (mainly mp-MRI) recurrence
Time frame: before surgery, during surgery, 6 months, 12 months after surgery
Failure-free survival (FFS) at 6 and 12 months postoperatively
Failure-free survival (FFS) were collected up to 12 months after surgery.
Time frame: before surgery, during surgery, 6 months, 12 months after surgery
Postoperative overall survival rate
Overall survival rates were collected up to 24 months after surgery.
Time frame: before surgery, during surgery,2 months, 6 months, 9 months, 12 months, 18 months and 24 months after radical surgery
Overall postoperative complication rate
Overallpostoperative complication rates were collected up to 24 months after surgery.
Time frame: before surgery, during surgery,2 months, 6 months, 9 months, 12 months, 18 months and 24 months after radical surgery
Number of device defects
The number of perioperative device defects was counted
Time frame: before surgery, during surgery
Plan to share: Yes — Wang yanqing, Dong bojun, Pan jiye and Zhu yinjie shared the research results with the research members of the project.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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