Image-Guided (68Ga-PSMA-11 PET/CT) Prostate Biopsy for the Diagnosis of Prostate Cancer in Men With Prior Negative/Inconclusive Biopsy
Running, not enrolling · Early Phase 1
Conditions studied: Prostate Carcinoma
In brief
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.
Key facts
- Study ID
- NCT05160597
- Run by
- Jonsson Comprehensive Cancer Center
- People needed
- 30
- Starts
- 2022-01-13
- Expected to finish
- 2027-01-07
- Last updated by the study team
- 2026-02-12
Who can join
Age: 18 and older, up to 90. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Men with suspicion of clinically significant prostate cancer with prior inconclusive, discordant or negative magnetic resonance imaging/ultrasound (MRI/US) fusion prostate biopsy
- Scheduled for a repeat transrectal ultrasound (TRUS) prostate biopsy by standard of care
- Focal 68Ga-PSMA-11 uptake within the prostate
You may not qualify if…
- Negative 68Ga-PSMA-11 uptake within the prostate (screening failure)
- Age < 18 and > 90 years
- Recurrent prostate cancer
- Inability to provide written informed consent
- Known inability to remain still and lie flat for the duration of the PET/CT (about 30 minutes)
Where it is running
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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