Study Title
Evaluation of 68Ga-PSMA-11 PET Guided Prostate Biopsy in Men With Suspicion of Clinically Significant Prostate Cancer and Prior Negative/Inconclusive Biopsy: A Prospective Exploratory Study
Study Details
Description:
This early phase I trial studies how well an image-guided prostate biopsy using the imaging agent 68Ga-prostate-specific membrane antigen (PSMA)-11 with a positron emission tomography/computed tomography (PET/CT) scan works in diagnosing prostate cancer in men with a prior negative or inconclusive prostate biopsy. PSMA is a protein that is found on the surface of prostate cancer cells. 68Ga-PSMA-11 is made up of a substance that binds to PSMA on tumor cells, linked with a radioactive substance that can then be seen on imaging scans such as PET/CT. 68Ga-PSMA-11 PET/CT-guided biopsy may help improve the detection rate of prostate cancer. This may help reduce over-diagnosis and over-treatment in men with low-risk prostate cancer and under-treatment in men with high-risk prostate cancer.
Sponsor:
Jonsson Comprehensive Cancer Center (UCLA)
Contacts:
Maria Contreras (Clinical Research Coordinator)mmcontreras@mednet.ucla.edu
310-825-7336
Stephanie Lira (Clinical Trials Program Manager)stephanielira@mednet.ucla.edu
310-206-7372
Government Study Link:
NCT05160597 - Click here to see study onClinicalTrials.gov
- Focal 68Ga-PSMA-11 uptake within the prostate
- Scheduled for a repeat transrectal ultrasound (TRUS) prostate biopsy by standard of care
- Men with suspicion of clinically significant prostate cancer with prior inconclusive or negative fusion prostate biopsy
- Recurrent prostate cancer
- Known inability to remain still and lie flat for the duration of the PET/CT (about 30 minutes)
- Negative 68Ga-PSMA-11 uptake within the prostate (screening failure)
- Inability to provide written informed consent
- Age < 18 and > 90 years
Patient Education
Patient Education Not Yet Provided
Publications
Publications Not Yet Provided
