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

NCT ID: NCT02786459

Last Updated: 2019-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-04-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Post Radical Prostatectomy

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.

Group Type: EXPERIMENTAL

ProxiScan

Intervention Type: DEVICE

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.

Magnetic Resonance Imaging

Intervention Type: DEVICE

Used as a comparative to ProxiScan.

SPECT-CT

Intervention Type: DEVICE

Used as a comparative to ProxiScan.

Active Surveillance

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.

Group Type: ACTIVE_COMPARATOR

ProxiScan

Intervention Type: DEVICE

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.

Magnetic Resonance Imaging

Intervention Type: DEVICE

Used as a comparative to ProxiScan.

SPECT-CT

Intervention Type: DEVICE

Used as a comparative to ProxiScan.

Multiple Negative Biopsies

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.

Group Type: EXPERIMENTAL

ProxiScan

Intervention Type: DEVICE

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.

Magnetic Resonance Imaging

Intervention Type: DEVICE

Used as a comparative to ProxiScan.

SPECT-CT

Intervention Type: DEVICE

Used as a comparative to ProxiScan.

Interventions

ProxiScan

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

Magnetic Resonance Imaging

Used as a comparative to ProxiScan.

Intervention Type: DEVICE

SPECT-CT

Used as a comparative to ProxiScan.

Intervention Type: DEVICE

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.

• 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hybridyne Imaging Technologies Inc

UNKNOWN

Sponsor Role: collaborator

Aytu BioPharma, Inc.

INDUSTRY

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

15-8723-C

Identifier Type: -

Identifier Source: org_study_id