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Detection and Localization of Carcinoma Using High Resolution Transrectal Imaging - Proof of Concept Study (ProxiScan)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ProxiScan
Magnetic Resonance Imaging
SPECT-CT
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate, Local Recurrence, Radical Prostatectomy

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Group 1: Rising PSA (biochemical failure) following radical prostatectomy. Group 2: Rising PSA (>10ng/ml) and/or abnormal digital rectal exam suspicious for prostate cancer. Previously negative prostate biopsies.

Group 3: Scheduled biopsy for known PCa (patient on AS). At least 1 previously positive prostate biopsy for adenocarcinoma of the prostate.

Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:

  • Sufficient time period to complete the imaging protocol and 7 to 9 day safety follow-up assessment without 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 (see appendix section).
  • Patient is between 35 and 75 years of age.

Exclusion Criteria:

The presence of any of the following will exclude a patient from study enrollment:

  • 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.
  • Patients with pacemakers, neurostimulators, and foreign metal bodies will be excluded as they will be unable to undergo an MRI and SPECT-CT.
  • Prior history of murine antibody infusion, patients who are hypersensitive to products of murine origin or indium-111 chloride.
  • 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.
  • Severe psychiatric or medical illness that may interfere with compliance with the study protocol or follow-up as deemed by the investigator.

Sites / Locations

  • Princess Margaret Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Post Radical Prostatectomy

Active Surveillance

Multiple Negative Biopsies

Arm Description

Up to n=30 evaluable male patients, between ages 30-75, who were previously diagnosed with PCa, have undergone a RP at least 6 months before imaging and who experience rising PSA (biochemical failure). The RP group (n=30) will be stratified into PSA subgroups <0.005, 0.005-<0.2, >0.2. Intervention: men will be imaged with ProxiScan, SPECT-CT and MRI.

Up to n=10 men, between ages 30-75, on active surveillance with known prostate adenocarcinoma diagnosis and multiple positive biopsies. Intervention: men will be imaged with ProxiScan, SPECT-CT and MRI, and also undergo a TRUS biopsy.

Up to n=20 men, between ages 30-75, who have previously undergone one/or multiple negative biopsies, with elevated PSA (≥4 ng/mL) and/or an abnormal digital rectal exam suspicious for prostate cancer with a planned sextant prostate biopsy but who do not have a definitive PCa diagnosis. Intervention: men will be imaged with ProxiScan, SPECT-CT and MRI, and also undergo a TRUS biopsy.

Outcomes

Primary Outcome Measures

Tumor localization.
Identification of tumour and/or tumour recurrence in the pelvis with imaging.

Secondary Outcome Measures

Full Information

First Posted
May 4, 2016
Last Updated
May 30, 2019
Sponsor
University Health Network, Toronto
Collaborators
Hybridyne Imaging Technologies Inc, Aytu BioPharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02786459
Brief Title
Detection and Localization of Carcinoma Using High Resolution Transrectal Imaging - Proof of Concept Study
Acronym
ProxiScan
Official Title
Detection and Localization of Carcinoma Using High Resolution Transrectal Imaging - Proof of Concept Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Hybridyne Imaging Technologies Inc, Aytu BioPharma, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
An exploratory, feasibility and proof-of-concept study to evaluate the capability of a rectal probe scintigraphy device (ProxiScanTM) to detect PSMA specific radiopharmaceutical agent (ProstaScint®; as a surrogate marker for prostate cancer) in patients who have undergone a radical prostatectomy for their disease, patients with multiple negative prostate biopsies and patients with known primary prostate cancer. Developed by Hybridyne Imaging Technologies, Inc. ProxiScanTM is a small cadmium zinc telluride (CST)-based compact gamma camera. It is the same size as a trans-rectal ultrasound (TRUS), currently used for prostate biopsy guidance. Men with multiple positive biopsies will be considered controls. Prostate cancer sextant biopsy histology results will be correlated with ProxiScanTM, TRUS, MRI and SPECT/CT. The investigators hypothesize that it will be safe and feasible to utilize a rectal probe scintigraphy (ProxiScanTM) to detect PSMA specific ProstaScint®, thus identifying and localizing the tumour sites within the prostate and surrounding areas.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate, Local Recurrence, Radical Prostatectomy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post Radical Prostatectomy
Arm Type
Experimental
Arm Description
Up to n=30 evaluable male patients, between ages 30-75, who were previously diagnosed with PCa, have undergone a RP at least 6 months before imaging and who experience rising PSA (biochemical failure). The RP group (n=30) will be stratified into PSA subgroups <0.005, 0.005-<0.2, >0.2. Intervention: men will be imaged with ProxiScan, SPECT-CT and MRI.
Arm Title
Active Surveillance
Arm Type
Active Comparator
Arm Description
Up to n=10 men, between ages 30-75, on active surveillance with known prostate adenocarcinoma diagnosis and multiple positive biopsies. Intervention: men will be imaged with ProxiScan, SPECT-CT and MRI, and also undergo a TRUS biopsy.
Arm Title
Multiple Negative Biopsies
Arm Type
Experimental
Arm Description
Up to n=20 men, between ages 30-75, who have previously undergone one/or multiple negative biopsies, with elevated PSA (≥4 ng/mL) and/or an abnormal digital rectal exam suspicious for prostate cancer with a planned sextant prostate biopsy but who do not have a definitive PCa diagnosis. Intervention: men will be imaged with ProxiScan, SPECT-CT and MRI, and also undergo a TRUS biopsy.
Intervention Type
Device
Intervention Name(s)
ProxiScan
Intervention Description
ProxiScan probe will be coupled with ProstaScint (a radioactive tracer) and used to perform imaging to detect small lesions in the pelvis that will otherwise be hard to detect with conventional imaging modalities.
Intervention Type
Device
Intervention Name(s)
Magnetic Resonance Imaging
Intervention Description
Used as a comparative to ProxiScan.
Intervention Type
Device
Intervention Name(s)
SPECT-CT
Intervention Description
Used as a comparative to ProxiScan.
Primary Outcome Measure Information:
Title
Tumor localization.
Description
Identification of tumour and/or tumour recurrence in the pelvis with imaging.
Time Frame
Within 2 days of imaging.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Group 1: Rising PSA (biochemical failure) following radical prostatectomy. Group 2: Rising PSA (>10ng/ml) and/or abnormal digital rectal exam suspicious for prostate cancer. Previously negative prostate biopsies. Group 3: Scheduled biopsy for known PCa (patient on AS). At least 1 previously positive prostate biopsy for adenocarcinoma of the prostate. Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study: Sufficient time period to complete the imaging protocol and 7 to 9 day safety follow-up assessment without 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 (see appendix section). Patient is between 35 and 75 years of age. Exclusion Criteria: The presence of any of the following will exclude a patient from study enrollment: 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. Patients with pacemakers, neurostimulators, and foreign metal bodies will be excluded as they will be unable to undergo an MRI and SPECT-CT. Prior history of murine antibody infusion, patients who are hypersensitive to products of murine origin or indium-111 chloride. 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. Severe psychiatric or medical illness that may interfere with compliance with the study protocol or follow-up as deemed by the investigator.
Facility Information:
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Detection and Localization of Carcinoma Using High Resolution Transrectal Imaging - Proof of Concept Study

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