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

Early Phase 1UnknownNCT01394042

Radiological Associates of Sacramento Medical Group Inc.12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Enrollment

Conditions

Prostate Cancer

Interventions

Proxiscan deviceDEVICE

All patients will be imaged with the device

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Roseville PET and Nuclear Imaging Center

Roseville, California, United States

Outcomes

Primary Outcomes

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

Time frame: Within on month of scan and corresponding MRI

Data from ClinicalTrials.gov

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