Evaluation of 68Ga-PSMA-11 PET Guided Prostate Biopsy in Men With Suspicion of Clinically Significant Prostate Cancer and Prior Negative/Inconclusive Biopsy: A Prospective Exploratory Study
Overview
- Phase
- Early Phase 1
- Intervention
- Biopsy of Prostate
- Conditions
- Prostate Carcinoma
- Sponsor
- Jonsson Comprehensive Cancer Center
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Detection rate of clinically significant prostate cancer
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
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.
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).
Investigators
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)
Arms & Interventions
Diagnostic (68Ga-PSMA-11, image-guided prostate biopsy)
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. IMAGE-GUIDED BIOPSY: Patients undergo experimental image-guided prostate biopsy using PET/CT images obtained during screening procedure during a standard of care TRUS.
Intervention: Biopsy of Prostate
Diagnostic (68Ga-PSMA-11, image-guided prostate biopsy)
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. IMAGE-GUIDED BIOPSY: Patients undergo experimental image-guided prostate biopsy using PET/CT images obtained during screening procedure during a standard of care TRUS.
Intervention: Gallium Ga 68 Gozetotide
Diagnostic (68Ga-PSMA-11, image-guided prostate biopsy)
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. IMAGE-GUIDED BIOPSY: Patients undergo experimental image-guided prostate biopsy using PET/CT images obtained during screening procedure during a standard of care TRUS.
Intervention: Transrectal Ultrasonography Guided Biopsy
Outcomes
Primary Outcomes
Detection rate of clinically significant prostate cancer
Time Frame: Up to 3 years
Defined as the percentage of clinically significant prostate cancer (Gleason score 7 or more) in patients with focal 68Ga-PSMA-11 uptake within the prostate