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 @ 6:52 PM
Ignite Modification Date:
2025-12-24 @ 6:52 PM
NCT ID:
NCT01496157
Eligibility Criteria:
Inclusion Criteria:
1. Newly diagnosed prostate cancer pathologically proven by prostate biopsy
2. Prostate biopsy histology grade ≥ Gleason 3+3=6.
3. Patients considered as candidates for and medically fit to undergo prostatectomy
4. At least 10 days after most recent prostate biopsy
5. No known problems with peripheral IV or central line access
6. Able to tolerate urinary straight catheter placement
7. Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits.
8. Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.
Exclusion Criteria:
1. Prior pelvic external beam radiation therapy or brachytherapy
2. Chemotherapy for prostate cancer
3. Hormone deprivation therapy
4. Investigational therapy for prostate cancer
5. Hemorrhagic cystitis or active prostatitis
6. Unable to lie flat during or tolerate PET/CT
7. Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer
8. No prostatectomy scheduled prior to follow-up visit (12 to 72 hours post imaging)
9. Serum creatinine \> 1.5 mg/dL or creatinine clearance \< 50 mL/min/1.73m2
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01496157
Study Brief:
Protocol Section:
NCT01496157