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

Study 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).

Official Title
-----------------
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

Conditions
-----------------
Prostate Carcinoma

Intervention / Treatment
-----------------
* Procedure: Biopsy of Prostate
* Other: Gallium Ga 68 Gozetotide
* Procedure: Transrectal Ultrasonography Guided Biopsy


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (68Ga-PSMA-11, image-guided prostate biopsy)<br>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. | Procedure: Biopsy of Prostate<br>* Undergo image-guided prostate biopsy<br>* Other names: Prostatic Biopsy;Other: Gallium Ga 68 Gozetotide<br>* Given IV<br>* Other names: PSMA-HBED-CC GA-68;Procedure: Transrectal Ultrasonography Guided Biopsy<br>* Undergo standard of care TRUS<br>* Other names: TRUS-Guided Biopsy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate of clinically significant prostate cancer | 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 | Up to 3 years |