Back to resultsEvaluation of a Transrectal Scintigraphic Detector(ProxiScanTM) for Detection of Primary Prostate Cancer
Primary Purpose
Suspected Primary Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ProxiScan (scintigraphic rectal probe)
Sponsored by
About this trial
This is an interventional diagnostic trial for Suspected Primary Prostate Cancer focused on measuring Suspected Primary Prostate Cancer
Eligibility 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.
Sites / Locations
- Johns Hopkins Outpatient Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Suspected Primary Prostate Cancer
Arm Description
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.
Outcomes
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.
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
Secondary Objectives:
Estimate the sensitivity and specificity for three methods of detection: TRUS, ProxiScan and SPECT/CT when compared to biopsy.
Estimate the sensitivity and specificity for ProxiScan and SPECT/CT when compared to PSMA IHC measurements.
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.
Explore reclassification properties of the ProxiScan results compared to the SPECT/CT at the patient level.
Full Information
NCT ID
NCT01359189
First Posted
May 19, 2011
Last Updated
August 31, 2016
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT01359189
Brief Title
Evaluation of a Transrectal Scintigraphic Detector(ProxiScanTM) for Detection of Primary Prostate Cancer
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®)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
Johns Hopkins University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suspected Primary Prostate Cancer
Keywords
Suspected Primary Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Suspected Primary Prostate Cancer
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
ProxiScan (scintigraphic rectal probe)
Intervention Description
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."
Primary Outcome Measure Information:
Title
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.
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
TRUS, ProxiScan and SPECT/CT when compared to biopsy
Description
Secondary Objectives:
Estimate the sensitivity and specificity for three methods of detection: TRUS, ProxiScan and SPECT/CT when compared to biopsy.
Estimate the sensitivity and specificity for ProxiScan and SPECT/CT when compared to PSMA IHC measurements.
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.
Explore reclassification properties of the ProxiScan results compared to the SPECT/CT at the patient level.
Time Frame
12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Cho, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Outpatient Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21227
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of a Transrectal Scintigraphic Detector(ProxiScanTM) for Detection of Primary Prostate Cancer
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