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

NCT01394042 | Unknown Early Phase 1 DMC

• 1 other identifier: Proxiscan
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Biopsy proven primary prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

No intervention

NO INTERVENTION

All consenting patients will be imaged with the Proxiscan and data compared with MRI, ProstaScint and biopsy data

Device: Proxiscan device

Interventions

Proxiscan device DEVICE

All patients will be imaged with the device

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radiological Associates of Sacramento Medical Group Inc.: lead
• Hybridyne Imaging Technologies: collaborator

Study Sites (1)

Roseville PET and Nuclear Imaging Center

Roseville, California, 95661, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Benjamin Franc, MD

  Radiological Associates of Sacramento Medical Group Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: July 14, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2012
• Last Updated: July 14, 2011

Record last verified: 2011-07

Locations

US (1)