Localized Prostate CancerHIFUNCT06362577
Clinical Study of HIFU for Localized Prostate Cancer
An observational study of Localized Prostate Cancer, run by RenJi Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Localized Prostate Cancer
- What is being tested?
- EQ-5D-5L IPSS IIEF-5 EPIC-26 ECOG
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital-Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200001
Yanqing Wang
About this study
Official title: Post-marketing Clinical Study of Transrectal High-intensity Focused Ultrasound for Localized Prostate Cancer
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.
Read the 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.
- Conditions
- Localized Prostate Cancer
- Being tested
- EQ-5D-5L IPSS IIEF-5 EPIC-26 ECOG
- Keywords
- HIFU, Localized prostate cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EQ-5D-5L IPSS IIEF-5 EPIC-26 ECOGDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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) . Receives: 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) . Receives: Diagnostic Test: EQ-5D-5L IPSS IIEF-5 EPIC-26 ECOG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative complications
The data were collected through medical records inquiry, consultation and questionnaire
Measured: 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
The PSA data was obtained by collecting postoperative PSA data at 1 month, 3 months, and 6 months.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: before surgery, during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start21 May 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Prostate CancerStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xue Wei, Doctor's, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362577
- Sponsor's protocol ID
- TSC202202
- Acronym
- HIFU
- Status last verified
- Aug 2024
- First submitted
- 17 Mar 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Wang yanqing, Dong bojun, Pan jiye and Zhu yinjie shared the research results with the research members of the project.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Clinical Study of Transrectal High-intensity Focused Ultrasound for Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT06362577
- Acronym / sponsor ID
- HIFU / TSC202202
- Conditions
- Localized Prostate Cancer
- Keywords
- HIFU, Localized prostate cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 21 May 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-intensity focused ultrasound. | – | Diagnostic Test: EQ-5D-5L IPSS IIEF-5 EPIC-26 ECOGMedical 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) . |
| robot-assisted laparoscopic radical prostatectomy | – | Diagnostic Test: EQ-5D-5L IPSS IIEF-5 EPIC-26 ECOGMedical 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) . |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- Either must be \"No\" or the patient cannot be enrolled.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EQ-5D-5L IPSS IIEF-5 EPIC-26 ECOGDiagnostic Test were collected at before surgery, during surgery,2 months, 6 months, 9 months, 12 months, 18 months and 24 months after radical surgery | Diagnostic test | high-intensity focused ultrasound., robot-assisted laparoscopic radical prostatectomy |
Primary outcome
Incidence of postoperative complications
Time frame: before surgery, during surgery,2 months, 6 months, 9 months, 12 months, 18 months and 24 months after radical surgery
The data were collected through medical records inquiry, consultation and questionnaire
7 secondary outcomes
Prostate-specific antigen (PSA), PSA levels at 1 month, 3 months, and 6 months after surgery
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
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
Time frame: before surgery, during surgery, 6 months, 12 months after surgery
Failure-free survival (FFS) at 6 and 12 months postoperatively
Time frame: before surgery, during surgery, 6 months, 12 months after surgery
Postoperative overall survival rate
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
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
Time frame: before surgery, during surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: Yes. Wang yanqing, Dong bojun, Pan jiye and Zhu yinjie shared the research results with the research members of the project.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xue Wei, Doctor's principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Localized Prostate Cancer, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang YanQing, Master's (13917826792, iwangyq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative complications (time frame: before surgery, during surgery,2 months, 6 months, 9 months, 12 months, 18 months and 24 months after radical surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.