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

Early Phase 1

• Conditions: Prostate Cancer
• Interventions: Device: Proxiscan device

• Registration Number: NCT01394042
• Lead Sponsor: Radiological Associates of Sacramento Medical Group Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Status Verified: 2011-07
• Study First Submitted: 2011-07-01
• Study First Submitted QC: 2011-07-12
• Last Update Submitted: 2011-07-12
• Study First Posted: 2011-07-14
• Last Update Posted: 2011-07-14
• Primary Completion: 2011-12
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
No intervention	Proxiscan device	All consenting patients will be imaged with the Proxiscan and data compared with MRI, ProstaScint and biopsy data

Primary Outcome Measures

Name	Time	Method
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	Within on month of scan and corresponding MRI	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

Trial Locations

Locations (1)

Roseville PET and Nuclear Imaging Center; 🇺🇸 Roseville, California, United States