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 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
NCT ID:
NCT01830166
Eligibility Criteria:
Inclusion Criteria:
* Must be 18 years of age or older
* Must be able to give informed consent
* Histologic diagnosis of prostate adenocarcinoma made on transrectal guided prostate biopsy with no fewer than 6 cores taken
* The prostate cancer is considered suitable for a strategy of active surveillance as well as conventional radical treatment.
* No more than 2 cores from one lobe containing cancer
* Gleason sum no greater than 3+4 =7 in any one core
* Clinical T stage no higher than T2a
* Serum prostate-specific antigen (PSA) no higher than 10 ng/mL
* No previous radiation therapy to the pelvis
* No prior history of malignancy except non-melanoma skin cancer
* Must be suitable for general or spinal anesthesia
* Must not be on coumadin or other anticoagulants
* Must be suitable for multi-parametric MRI scan (excluded are those with significant renal impairment that would preclude the use of contrast agents and may exclude some patients with cardiac pacemaker, wires, or defibrillator; artificial heart valve; brain aneurysm clip; electrical stimulator for nerves or bones; ear or eye implant; implanted drug infusion pump; coil, catheter, or filter in any blood vessel. Some men with metallic prostheses; shrapnel, bullets, or other metal fragments retained in the body may be excluded as well.
Exclusion Criteria:
* They are unable to participate in an MRI scan.
* They are unable to undergo general or spinal anesthesia.
* They are on anticoagulation therapy (blood thinners).
* They have had previous radiotherapy to the pelvis.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01830166
Study Brief:
Protocol Section:
NCT01830166