Clinical Study of HIFU for Localized Prostate Cancer
ConditionLocalized Prostate Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age40+
SponsorRenJi Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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;
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
EQ-5D-5L IPSS IIEF-5 EPIC-26 ECOG
Diagnostic testDiagnostic Test were collected at before surgery, during surgery,2 months, 6 months, 9 months, 12 months, 18 months and 24 months after radical surgery
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: high-intensity focused ultrasound.1 intervention
Group B: robot-assisted laparoscopic radical prostatectomy1 intervention
Trial outcomes
Primary outcomes
1
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 surgerySecondary outcomes
1
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,2
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 surgery3
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 surgery4
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 surgerySponsors and contacts
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Source ClinicalTrials.gov