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 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT02786459
Eligibility Criteria:
Inclusion Criteria:
Group 1: Rising PSA (biochemical failure) following radical prostatectomy. Group 2: Rising PSA (\>10ng/ml) and/or abnormal digital rectal exam suspicious for prostate cancer. Previously negative prostate biopsies.
Group 3: Scheduled biopsy for known PCa (patient on AS). At least 1 previously positive prostate biopsy for adenocarcinoma of the prostate.
Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
* Sufficient time period to complete the imaging protocol and 7 to 9 day safety follow-up assessment without therapeutic intervention.
* Patient is judged by the Investigator to have the initiative and means to provide written consent and be compliant with the protocol and be able and commits to make the required study visits.
* Ambulatory with ECOG performance status of 0 or 1 (see appendix section).
* Patient is between 35 and 75 years of age.
Exclusion Criteria:
The presence of any of the following will exclude a patient from study enrollment:
* Patient or physician plans definitive concomitant chemotherapy, therapeutic radiation treatment, biologic treatment and/or local ablative treatment for cancer within the interval of study participation.
* Patients with pacemakers, neurostimulators, and foreign metal bodies will be excluded as they will be unable to undergo an MRI and SPECT-CT.
* Prior history of murine antibody infusion, patients who are hypersensitive to products of murine origin or indium-111 chloride.
* Prior therapeutic pelvic irradiation.
* Recent prostate biopsy, within 1 month of study enrollment.
* Patient with contraindications to TRUS-guided prostate biopsy (continuous need for anti-coagulation, no rectum, etc.)
* Clinical evidence of prostatitis, or other benign prostate gland abnormality, that would explain elevated PSA and/or (digital rectal exam) DRE findings.
* Active malignancy or therapy for malignancy within 6 months, other than basal or squamous cell carcinoma of the skin.
* Patient received a radiopharmaceutical which was within 5 physical half-lives at the time of study imaging.
* Severe psychiatric or medical illness that may interfere with compliance with the study protocol or follow-up as deemed by the investigator.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT02786459
Study Brief:
Protocol Section:
NCT02786459