Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-24 @ 9:38 PM
NCT ID:
NCT03838432
Eligibility Criteria:
Inclusion Criteria:
1. The therapy must be thoroughtly understood with the agreement signed
2. Prostate MRI can identify negative extracapsular extension and seminal vesicle involvement,and no evidence of lymphatic metastasis
3. Patients must have confirmed prostate cancer by prostate maping biopsy
4. Low-risk or intermediate risk prostate cancer(PSA\<20ng/ml,T1a-T2c,Gleason Score≤7)
5. There must be no evidence of metastatic disease as confirmed by ECT and whole-body MRI
6. No prostatic calculus or prostatic calculus≤5mm
7. Age ≥ 40 - ≤ 85 years
8. Life expectancy of greater than 5 years(WHO Performance Status 0-1)
9. Patients with fertility are willing to take contraceptive measures until the end of the trial
Exclusion Criteria:
1. Patients have previously undergone radical prostatectomy, hormonal therapy or radiotherapy.
2. Patients underwent other surgery before less than 3 months.
3. Patients required long-term medication with anticoagulans or stop taking anticoagulans less than 1 months
4. Patients with clinically significant cardiovascular disease or other serious diseases
5. Patients with metal implants in their bodys(for example,cardiac pacemaker ) and/or with metal implants which located in the range from the first lumbar vertebra(L1) to the middle of femurs.
6. Patients with history of epilepsy
7. Patients with other malignant tumor or patients with hiv.
8. Patients with other serious systemic diseases that the study believes may interfere with the treatment, evaluation, and compliance of the trial;
9. Patients with participation in another clinical trial less than 3 months.
10. Patients with the judge that they are not suitable for this clinical trial
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT03838432
Study Brief:
Protocol Section:
NCT03838432