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Initial Exploratory Evaluation of a Transrectal Scintigraphic Detector (ProxiScanTM) for Detection of Primary Prostate Cancer Utilizing a Prostate Specific Membrane Antigen (PSMA) Based Radiotracer (ProstaScint®)

Phase 1
18 Years
75 Years
Open (Enrolling)
Suspected Primary Prostate Cancer

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Trial Information

Initial Exploratory Evaluation of a Transrectal Scintigraphic Detector (ProxiScanTM) for Detection of Primary Prostate Cancer Utilizing a Prostate Specific Membrane Antigen (PSMA) Based Radiotracer (ProstaScint®)

This is a feasibility, exploratory, and proof-of-concept study to evaluate rectal probe
scintigraphy device (ProxiScanTM) to detect PSMA specific radiopharmaceutical agent
(ProstaScint®) in patients with suspected primary prostate cancer. ProxiScanTM is a small
cadmium zinc telluride (CST)-based compact gamma camera the size of a trans-rectal
ultrasound (TRUS) developed by Hybridyne Imaging Technologies, Inc. Due to its inherent
small size, this camera is capable of potentially imaging of prostate cancer specific
radiopharmaceutical uptake distributed within the prostate gland located closely adjacent to
the camera head.In this study the investigators will enroll patients with a clinical
suspicion and high likelihood of prostate cancer. A scintigraphic rectal probe
(ProxiScanTM) will be used to detect ProstaScint® uptake in the prostate gland, in
comparison to TRUS and pelvis planar and SPECT/CT. The incidence of biopsy positive prostate
cancer in patients with suspected disease clinically can range from 25% to 40%; therefore up
to 12 patients will be enrolled on this study. To explore the adjunctive
benefit/feasibility of PSMA distribution in the normal prostate versus prostate cancer gland
utilizing TRUS and CT/SPECT hybrid imaging, biopsy negative patients will be considered as
normal controls. Prostate cancer sextant biopsy histology results will be correlated with
ProxiScanTM, TRUS, and pelvis planar and SPECT/CT. Our hypothesis is that it will be safe
and feasible to utilize a rectal probe scintigraphy (ProxiScanTM) to detect PSMA specific
ProstaScint® uptake in primary prostate cancer.

Inclusion Criteria:

- Elevated PSA ≥ 4ng/mL and/or abnormal digital rectal exam suspicious for prostate

- Planned sextant prostate biopsy.

- Sufficient time period to complete the imaging protocol and 5 to 7 day safety
follow-up assessment without prostate biopsy or therapeutic intervention.

- Patient is judged by the Investigator to have the initiative and means to provide
written consent and be compliant with the protocol and be able and commits to make
the required study visits.

- Ambulatory with ECOG performance status of 0 or 1; or Karnofsky performance scale of
≥ 70. (seen appendix below)

- Patient is between 30 and 75 years of age.

Exclusion Criteria:

- Patient or physician plans definitive concomitant chemotherapy, therapeutic radiation
treatment, biologic treatment and/or local ablative treatment for cancer within the
interval of study participation.

- Prior therapeutic pelvic irradiation.

- Recent prostate biopsy, within 1 month of study enrollment.

- Patient with contraindications to TRUS-guided prostate biopsy (continuous need for
anti-coagulation, no rectum, etc.)

- Clinical evidence of prostatitis, or other benign prostate gland abnormality, that
would explain elevated PSA and/or (digital rectal exam) DRE findings.

- Active malignancy or therapy for malignancy within 6 months, other than basal or
squamous cell carcinoma of the skin.

- Patient received a radiopharmaceutical which was within 5 physical half-lives at the
time of study imaging.

- Known history of human-anti-murine-antibodies (HAMA) or known allergic reaction to
previously received murine based products.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To determine the feasibility of a Transrectal Scintigraphic Detector (ProxiScanTM) to detect and localize prostate specific membrane antigen (ProstaScint®) radiotracer uptake in suspected primary prostate cancer patients.

Outcome Description:

The proximity of the placement of the ProxiScanTM device to the prostate should result in an improvement in the sensitivity and specificity for detection of prostate cancer specific radiopharmaceutical detection. The primary objectives will be evaluated at the patient level, while secondary objectives will be analyzed based on data and outcomes measured by region of the prostate (sextant).

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Steve Cho, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University


United States: Food and Drug Administration

Study ID:




Start Date:

May 2011

Completion Date:

September 2014

Related Keywords:

  • Suspected Primary Prostate Cancer
  • Suspected Primary Prostate Cancer
  • Prostatic Neoplasms



Johns Hopkins Outpatient CenterBaltimore, Maryland  21287