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
  Purpose

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.


Condition Intervention Phase
Suspected Primary Prostate Cancer
Device: ProxiScan (scintigraphic rectal probe)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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®)

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 15
Study Start Date: May 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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."

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359189

Locations
United States, Maryland
Johns Hopkins Outpatient Center
Baltimore, Maryland, United States, 21227
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Johns Hopkins University
Investigators
Principal Investigator: Steve Cho, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01359189     History of Changes
Other Study ID Numbers: J1050
Study First Received: May 19, 2011
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Suspected Primary Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 21, 2014