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 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT00807820
Eligibility Criteria:
Inclusion Criteria:
* Patient must be a candidate for HDR prostate brachytherapy
* Patient must be able to have MR scan
* Patient must have a visible DIL on MRS
* Patient has signed the protocol consent form
* No prior pelvic or prostate radiation or chemotherapy for any reason
* Induction hormonal therapy beginning ≤ 120 days prior to study entry is acceptable only if there is a MRI/MRS done prior to starting hormonal therapy
* Prostate specific antigen prior to any (hormonal) therapy must be ≤ 20 ng/ml
One of the following combinations of factors:
* Clinical stage T2a-2b, Gleason score 2-6 and PSA ≥ 10 but ≤ 20
* Clinical stage T3a-T3b, Gleason score 2-6 and PSA ≤ 20
* Clinical stage T2a-T3b, Gleason score 7-10 and PSA ≤ 20
Exclusion Criteria:
* Patient with hip prosthesis
* Patient with pacemaker
* Patient with history of radical surgery for prostate
* Patient with claustrophobia
* Patient with metal in body not safe for MR
* Stage T4 disease
* Lymph node involvement (N1)
* Evidence of distant metastases (M1)
* Previous hormonal therapy beginning \> 120 days prior to registration
* Hormonal therapy prior to MRI/MRS
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT00807820
Study Brief:
Protocol Section:
NCT00807820