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

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

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01394042

Enrollment

Registered

2011-07-14

Start date

2011-06-30

Completion date

2012-03-31

Last updated

2011-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Biopsy proven primary prostate cancer

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.

Interventions

DEVICEProxiscan device

All patients will be imaged with the device

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026