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 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT01354951
Eligibility Criteria:
Inclusion Criteria:
* Men ≥ 21 years of age with a life expectancy estimated to be \> 10-years.
* Diagnosis of adenocarcinoma of the prostate confirmed by MSKCC or participating site pathology review.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Prostate cancer clinical stage T1c-T2a
* PSA \< 10ng/mL (this will be the PSA level prompting the prostate biopsy)
* MRI evidence of one-sided disease performed within 3 months of registration
* Prostate size \<60 cc at time of treatment- if the prostate is larger, hormonal therapy is allowed to achieve the required size Screening biopsy parameters:
* Minimum of 10 biopsy cores
* Gleason grade 7 in two cores or less, with no primary Gleason grade 4 or 5 in any cores
* Unilateral cancer (only right-sided or left-sided, not bilateral)
* No more than 50 % cancer in any one biopsy core
* No more than 25 % of cores containing cancer
* Repeat transrectal or transperineal prostate biopsy that must meet the following parameters:
* Minimum of 12 biopsy cores
* Unilateral cancer (only right-sided or left-sided, not bilateral)
* Gleason grade 7 in two cores or less, with no primary Gleason grade 4 or 5 in any cores
* No more than 50 % cancer in any one biopsy core
* No more than 25 % of cores containing cancer
Subject Exclusion Criteria:
* Medically unfit for anesthesia
* Evidence or suspicion of extracapsular extension on MRI
* IPSS score \> 18
* Unable to receive MRI
* Prior radiotherapy for the current disease
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
21 Years
Study:
NCT01354951
Study Brief:
Protocol Section:
NCT01354951