Prostate Cancer Imaging With Radioactive Tracer and Ultrasound Detector Compared to MRI and ProstaScint

Study Overview
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Brief Summary
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This is a small study to determine if probe, similar to an ultrasound probe, can detect prostate cancer more specifically than other imaging studies in patients with a positive prostate cancer biopsy.

Official Title
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Exploratory Evaluation of a Transrectal Scintigraphic Detector (Proxiscan) for Detection of Primary Prostate Cancer Utilizing a Radiotracer Targeting Prostate Specific Membrane Antigen (PMSA)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Proxiscan device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary prostate cancer proven by sextant prostate biopsy Transrectal ultrasound (TRUS)-guided prostate biopsy within 6 months of study enrollment Sufficient time period to complete imaging protocol and 5-7 day safety followup assessment without other therapeutic intervention In the judgement of principal investigator, patient able to provide informed consent and be compliant with protocol requirements ECOG status of 0 or 1 Pt > 18 yrs of age Exclusion Criteria: Definitive or concomitant therapeutic intervention within the interval of study intervention Prior pelvic therapeutic radiation Active malignancy or therapy for malignancy with 6 months other than basal or squamous cell carcinoma of the skin Pt received radiopharmaceutical which was within 5 half-lives at the time of studying imaging Known history of human-anti-murine-antibodies or known allergic reaction to previously received murine based products

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No intervention<br>All consenting patients will be imaged with the Proxiscan and data compared with MRI, ProstaScint and biopsy data | Device: Proxiscan device<br>* All patients will be imaged with the device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of PSMA antibody (ProstaScint)uptake patterns measured by Proxiscan in comparison with anatomic biopsy reports, conventional SPECT and MRI scans within one month of Proxiscan | Detection of PSMA antibody (ProstaScint) uptake patterns measured by the new transrectal compact gamma camera (Proxiscan) will be compared to the anatomic biopsy reports along with Magnetic Resonance Imaging (MRI) and conventional ProstaScint (Single Photon Emission Computed Tomography) SPECT imaging results. All imaging and biopsy results performed within one month will be used for this investigation | Within on month of scan and corresponding MRI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biopsy proven primary prostate cancer