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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)


Phase 0
18 Years
N/A
Open (Enrolling by invite only)
Male
Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

Within on month of scan and corresponding MRI

Safety Issue:

No

Principal Investigator

Benjamin Franc, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radiological Associates of Sacramento Medical Group Inc.

Authority:

United States: Institutional Review Board

Study ID:

Proxiscan

NCT ID:

NCT01394042

Start Date:

June 2011

Completion Date:

March 2012

Related Keywords:

  • Prostate Cancer
  • Biopsy proven primary prostate cancer
  • Prostatic Neoplasms

Name

Location

Roseville PET and Nuclear Imaging CenterRoseville, California  95661