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 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT01985932
Eligibility Criteria:
Inclusion Criteria:
* Age 18 or older
* Male
* Biopsy proven prostate cancer without evidence of metastatic disease
* Planned definitive external beam RT with daily ERB and implanted Visicoil fiducial markers.
* Prior fMRI-ec documenting an IPL 25 mm2 in axial bidimensional diameter product, concordant with intraprostatic tumor location as documented on transrectal ultrasoundbiopsy
* Subject capable of giving informed consent for standard external beam RT and for the study.
* No current contraindication that would prevent MRI or gadolinium contrast.
Exclusion Criteria:
* Metastatic disease
* Lack of fMRI-ec documeneting an IPL 25 mm2 in axial bidimensional product, concordant with intraprostatic tumor location as documented on transrectal untrasound biopsy
* Neoadjuvant androgen deprivation therapy greater than 10 weeks, defined from date of LHRH analog injection to date of fMRI-sim
* Contraindication that would prevent MRI or gadolinium contrast
* GFR 30 mL/min/1.73m2 per Crockoft-Gault formula.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01985932
Study Brief:
Protocol Section:
NCT01985932