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:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT01522118
Eligibility Criteria:
Inclusion Criteria:
* Patient of age between 40 to 85
* Patient with organ-confined Pca (cT1c and cT2a, N0, M0), diagnosed with TRUS biopsy (min:12 cores)
* Patient with PSA ≤ 10 ng/mL
* Gleason score 6 (3+3) or max 7 (3+4)
* Up to two (2) MR identifiable lesions
* No definite evidence of extracapsular extension
Exclusion Criteria:
* Patient under medications that can affect PSA for the last 3 months prior to MRgFUS treatment (Androgen Deprivation Treatment; alpha reductase inhibitors)
* Any rectal pathology, anomaly or previous treatment
* Identified calcification of 2 mm or more in largest diameter neighboring the rectal wall
* Bladder cancer
* Seminal vesicle/lymph node
* Prostate with multiple cystic lesions
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT01522118
Study Brief:
Protocol Section:
NCT01522118