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 @ 11:47 PM
Ignite Modification Date:
2025-12-24 @ 11:47 PM
NCT ID:
NCT02391051
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18
* Histologically confirmed prostate cancer
* Gleason Score of index lesion ≤ 6 (3+3)
* Tumor stage: cT1-2a cN0 cM0
* Unilateral affection; index lesion ≤ 0.5ml with or without clinically non-significant lesion contralateral. No more than 25% of the punch should be affected. Therefore a 3D-TPM-biopsy is mandatory before treatment.
* PSA ≤ 10/ng/ml
* Prostate volume \< 60 m\^3
* No distant metastasis
* Life expectancy \> 10 years
* Informed consent
Exclusion Criteria:
* Tumor stage ≥ T2b
* Known metastasis: N+ and/or M1
* General anesthesia or peridural anesthesia is not possible
* Coagulation disorder
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02391051
Study Brief:
Protocol Section:
NCT02391051