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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT04582656
Eligibility Criteria:
Inclusion Criteria:
* Patient aged from 45 to 76 years old
* Life expectancy \>10 years at the inclusion time
* Patient diagnosed with an intermediate-risk prostate cancer, defined by:
* A T1c or T2a clinical stage
* A unique cancer focus of Gleason (3+4) (Grade Group 2)
* A PSA level \<20 ng/mL
* Cancer focus identified on a multiparametric MRI of the prostate no more than 3 months before inclusion
* Confirmation of the suspicion of cancer identified on the MRI with transrectal or transperineal targeted and systematic biopsies performed with the KOELIS TRINITY system (no more than 3 months before inclusion)
* Patient suitable for IV sedation or general anesthesia and focal microwave ablation
* No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
* Known coagulopathy or bleeding disorders are controlled
* Free, informed and written consent, dated and signed before the enrollment and before any exam required by the trial
* Patient affiliated to social security regimen or beneficiary of such regimen for local regions
Exclusion Criteria:
* Past medical history of prostate surgery
* Past medical history of radiotherapy or pelvic trauma
* Past medical history of acute prostatitis
* Presently taking hormonal manipulation or androgen supplements.
* Past medical history of cancer in the 5 previous years, excluding a non-metastatic basal cell carcinoma of the skin
* Severe BPH-related urinary tract symptoms, defined by an IPSS score \>18
* Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to the screening visit
* Contraindications for MRI exam
* Extracapsular cancer extension or seminal vesicles or pelvic lymph node invasion suspected on prostate MRI
* Presence of two or more clinically significant cancer foci in the inclusion biopsy exam
* Presence of a clinically significant cancer with a Gleason score ≥8 (Grade Group ≥4)
* Tumor largest axis \>12 mm on the prostate MRI
* Distance between the cancer focus and the apex \<10 mm on the prostate MRI
* Distance between the cancer focus and the rectum \<5 mm on the prostate MRI
* Patient already participating in an interventional clinical trial
* Patient protected by law
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Maximum Age:
76 Years
Study:
NCT04582656
Study Brief:
Protocol Section:
NCT04582656