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
30
Conditions
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 biopsy -
OTHER:
Gallium Ga 68 GozetotideDescription:
Given IV -
PROCEDURE:
Transrectal Ultrasonography Guided BiopsyDescription:
Undergo standard of care TRUS
Outcome Measures
Primary Outcome Measures
Detection rate of clinically significant prostate cancer
Timeline
-
Last Updated
January 28, 2025 -
Start Date
December 16, 2021 -
Today
May 15, 2025 -
Completion Date ( Estimated )
January 7, 2027
Sponsors of this trial
-
Lead Sponsor
Jonsson Comprehensive Cancer Center
RECRUITING 
≥ 18 Years