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 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT02692105
Eligibility Criteria:
Inclusion Criteria:
* Clinical stage T1c-T2b, PSA \< 20, Gleason \< 8
* ECOG 0-1
* Low tier intermediate-risk prostate cancer is defined by;
o a single NCCN intermediate risk factor (either Gleason 7(3+4) and PSA \< 10 ng/ml OR Gleason 6 and PSA 10-20 ng/ml)
* Extensive favorable-risk disease is defined as:
* clinical stage T1c-T2a
* PSA \< 10
* Gleason 6
* ≥ 50% of biopsy cores containing cancer
* PSA density \> 0.2 ng/cc
* Selected intermediate risk patients not defined above
* \- T1c/T2a
* \- PSA \< 10
* -Gleason 4+3
* -\< 33% of cores involved
* -Max tumour length in any core 10 mm
* No androgen deprivation therapy (ADT)
* Prostate volume by TRUS ≤ 60 cc.
* Not eligible for, or accepting of, active surveillance according to NCCN guidelines.
* Signed study specific informed consent.
Exclusion Criteria:
* Prior radical surgery for carcinoma of the prostate,
* Prior pelvic radiation
* Prior chemotherapy for prostate cancer,
* Prior TURP or cryosurgery of the prostate
* Claustrophobic or unable to undergo MRI
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT02692105
Study Brief:
Protocol Section:
NCT02692105