Radiolabeled Gallium-68 (68Ga-PSMA) for PET/CT Imaging to Detect Prostate Cancer

• Status: Terminated
• Trial end date: 2020-02-27
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of the study is to find out whether imaging of the prostate with a new molecule called 68Ga-PSMA can find prostate cancer. 68Ga-PSMA has been shown in a large number of patients to be useful to find recurring prostate cancer following initial cancer treatment. This study is performed to test 68Ga-PSMA whether it can be used to find prostate cancers that would be considered in need for treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan Cancer Center; University of Michigan Rogel Cancer Center
• Treatments: Edetic Acid; Gallium 68 PSMA-11

Criteria

Inclusion Criteria:

• Recent MRI of the prostate has resulted in at least one lesion suspected to represent prostate cancer (reported by the Radiologist as PI-RADS 3, 4 or 5 lesion)

• Treating physician has already indicated a need for a prostate biopsy procedure.

• Known Gleason 6 or 7 prostate cancer OR rising PSA with either a) no prior biopsy or b) single or multiple negative prior biopsies.

Exclusion Criteria:

• Prostate biopsy within 12 weeks before enrollment

• Acute prostatitis within the last 6 months

• Current non-urologic bacterial infection requiring active treatment with antibiotics

• Active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years

• Body weight greater than 350 lbs (158 Kg)

• Inability or unwillingness to receive a prostate biopsy procedure

• Unable to lie flat, still, or tolerate a PET/CT scan

• Unable to provide own consent

• Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 6 months prior to study participation, unstable and uncontrolled hypertension, acute renal failure of any intensity, chronic renal or hepatic disease, severe pulmonary disease).