Open Actively Recruiting

Image-Guided (68Ga-PSMA-11 PET/CT) Prostate Biopsy for the Diagnosis of Prostate Cancer in Men With Prior Negative/Inconclusive Biopsy

About

Brief Summary

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.

Primary Purpose
Diagnostic
Study Type
Interventional
Phase
N/A

Eligibility

Gender
Male
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
90 Years

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Join this Trial

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Study Stats
Protocol No.
21-001122
Category
Molecular & Medical Pharmacology
Oncology
Principal Investigator
JEREMIE CALAIS
Contact
WESLEY ARMSTRONG
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05160597
For detailed technical eligibility, visit ClinicalTrials.gov.