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

  • Recruiting
  • Diagnostic
  • Interventional
  • Other & Procedure
  • EARLY_PHASE1
  • Jonsson Comprehensive Cancer Center
  • 18 - 90 Years

Study Purpose

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.

Intervention

Procedure : Biopsy of Prostate

Other : Gallium Ga 68 Gozetotide

Procedure : Transrectal Ultrasonography Guided Biopsy

Eligibility Requirements

info icon Men with suspicion of clinically significant prostate cancer with prior inconclusive, discordant or negative magnetic resonance imaging/ultrasound (MRI/US) fusion prostate biopsy

info icon Scheduled for a repeat transrectal ultrasound (TRUS) prostate biopsy by standard of care

info icon Focal 68Ga-PSMA-11 uptake within the prostate

info icon Negative 68Ga-PSMA-11 uptake within the prostate (screening failure)

info icon Age \< 18 and \> 90 years

info icon Recurrent prostate cancer

info icon Inability to provide written informed consent

info icon Known inability to remain still and lie flat for the duration of the PET/CT (about 30 minutes)

Recruiting status

Recruiting

Estimated enrollment

30

 
Study start date

Jan 13, 2022

Study end date

Jan 07, 2027

Last updated

Mar 23, 2025

Primary purpose

Diagnostic

Design

Interventional

Intervention

Other & Procedure

Study phase

EARLY_PHASE1

Allocation

Na

 

Sponsor:

Jonsson Comprehensive Cancer Center

Collaborator:

N/A

Investigator:

Jeremie Calais

N/A

Publications

N/A


Websites

N/A

NCT05160597

Clinic Location Investigator Distance RECRUITING STATUS Contact