Prostate Cancer Clinical Trial
Official title:
Exploratory Evaluation of a Transrectal Scintigraphic Detector (Proxiscan) for Detection of Primary Prostate Cancer Utilizing a Radiotracer Targeting Prostate Specific Membrane Antigen (PMSA)
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.
Status | Enrolling by invitation |
Enrollment | 12 |
Est. completion date | March 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Roseville PET and Nuclear Imaging Center | Roseville | California |
Lead Sponsor | Collaborator |
---|---|
Radiological Associates of Sacramento Medical Group Inc. | Hybridyne Imaging Technologies |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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