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 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT00928603
Eligibility Criteria:
Inclusion Criteria:
1. Clinical
* Clinical stage T1c or T2a
* PSA less than 10 ng/ml
* PSA velocity less than 2 ng/ml yearly in the year prior to diagnosis
2. Biopsy
* Minimum of 12 cores
* No Gleason grade 4 or 5
* Maximum percentage of cancer in each core (20%)
* Maximum length of cancer in each core ( 5 mm)
* Maximum percentage of total cores with cancer (20%)
3. Imaging
* Single lesion with a maximum size (12 mm)
* Maximum length of capsular contact (10 mm)
* No evidence of extraprostatic extension or seminal vesicle invasion
Exclusion Criteria:
1. Tumor in the transitional zone
2. Previous prostate surgery for benign pathology
3. Any rectal or perineal pathology hampering instrumentation and manipulation of the area
4. Benign or malignant rectal lesion
5. Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
76 Years
Study:
NCT00928603
Study Brief:
Protocol Section:
NCT00928603