Image-Guided (68Ga-PSMA-11 PET/CT) Prostate Biopsy for the Diagnosis of Prostate Cancer in Men With Prior Negative/Inconclusive Biopsy
Status
RECRUITING
Phase
EARLY_PHASE1
Age
18 - 90 Years
Enrollments
30Conditions
Prostate CarcinomaSummary
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.
Detailed Description
PRIMARY OBJECTIVE:
I. To assess the detection rate of clinically significant prostate cancer (Gleason score 7 or more) in patients with focal gallium Ga 68 gozetotide (68Ga-PSMA-11) uptake within the prostate.
OUTLINE:
SCREENING PROCEDURE: Patients receive 68Ga-PSMA-11 intravenously (IV) and 50-100 minutes later, undergo a PET/CT scan. Only patients with 68Ga-PSMA-11 uptake within the prostate proceed to image-guided biopsy.
IMAGE-GUIDED BIOPSY: Patients undergo experimental image-guided prostate biopsy using PET/CT images obtained during screening procedure during a standard of care transrectal ultrasonography guided biopsy (TRUS).
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Ethan Lam
- 310-206-7372
- [email protected]
Principal Investigator
- Jeremie Calais
Eligibility Criteria
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)
Study Plan
Diagnostic (68Ga-PSMA-11, image-guided prostate biopsy)
EXPERIMENTAL
SCREENING PROCEDURE: Patients receive 68Ga-PSMA-11 IV and 50-100 minutes later, undergo a PET/CT scan. Only patients with 68Ga-PSMA-11 uptake within the prostate proceed to image-guided biopsy.nnIMAGE-GUIDED BIOPSY: Patients undergo experimental image-guided prostate biopsy using PET/CT images obtained during screening procedure during a standard of care TRUS.
PROCEDURE:
Biopsy of ProstateDescription:
Undergo image-guided prostate biopsyOTHER:
Gallium Ga 68 GozetotideDescription:
Given IVPROCEDURE:
Transrectal Ultrasonography Guided BiopsyDescription:
Undergo standard of care TRUS
Outcome Measures
Primary Outcome Measures
Detection rate of clinically significant prostate cancer
Timeline
Last Updated
February 13, 2024Start Date
December 16, 2021Today
January 23, 2025Completion Date ( Estimated )
January 7, 2026
Sponsors of this trial
Lead Sponsor
Jonsson Comprehensive Cancer Center
RECRUITING 
21 - 64 Years