Evaluation of a Transrectal Scintigraphic Detector(ProxiScanTM) for Detection of Primary Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01359189
First received: May 19, 2011
Last updated: November 7, 2013
Last verified: October 2013

May 19, 2011
November 7, 2013
May 2011
September 2014   (final data collection date for primary 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. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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).
Same as current
Complete list of historical versions of study NCT01359189 on ClinicalTrials.gov Archive Site
TRUS, ProxiScan and SPECT/CT when compared to biopsy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Objectives:

  1. Estimate the sensitivity and specificity for three methods of detection: TRUS, ProxiScan and SPECT/CT when compared to biopsy.
  2. Estimate the sensitivity and specificity for ProxiScan and SPECT/CT when compared to PSMA IHC measurements.
  3. If prostatectomy histology results are available, the ability to detect areas of cancer among multiple slices of prostate tissue with TRUS, SPECT/CT and ProxiScan will be evaluated.
  4. Explore reclassification properties of the ProxiScan results compared to the SPECT/CT at the patient level.
Same as current
Not Provided
Not Provided
 
Evaluation of a Transrectal Scintigraphic Detector(ProxiScanTM) for Detection of Primary Prostate Cancer
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.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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Suspected Primary Prostate Cancer
Device: ProxiScan (scintigraphic rectal probe)
ProxiScanTM is a compact, high-resolution gamma camera which has been developed for the detection of cancer and other abnormalities in the body by imaging the distribution of radionuclides in the human body using planar imaging techniques. This camera is capable of high-performance imaging of radiopharmaceuticals distributed within anatomical regions of interest located close to the camera head. The ProxiScan compact scintigraphic detector was approved by the FDA to market the device for the following indication: "The ProxiScanTM is indicated for use in imaging the distribution of radionuclides in the human body using planar imaging techniques. ProxiScanTM may also be used intraoperatively, on pathological specimens and for endocavity applications if a protective sheath is used."
Experimental: Suspected Primary Prostate Cancer
Patients with suspected prostate cancer will be evaluated for initial proof of concept and feasibility of a scintigraphic rectal probe (ProxiScanTM) utilizing a PSMA receptor radiopharmaceutical (ProstaScint®). 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. This is an exploratory, open label trial and randomization is not required. Subject blinding is not needed and investigator blinding in not possible.
Intervention: Device: ProxiScan (scintigraphic rectal probe)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
15
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Elevated PSA ≥ 4ng/mL and/or abnormal digital rectal exam suspicious for prostate cancer.
  • 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.
Male
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01359189
J1050
Yes
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
Johns Hopkins University
Principal Investigator: Steve Cho, MD Johns Hopkins University
Sidney Kimmel Comprehensive Cancer Center
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP