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

Prostate Cancer Clinical Trial

— ProxiScan  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02786459
• Other study ID #: 15-8723-C
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: April 2019

Study information

• Verified date: May 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Device:
• 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.
• Magnetic Resonance Imaging
Used as a comparative to ProxiScan.
• SPECT-CT
Used as a comparative to ProxiScan.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University Health Network, Toronto	Aytu BioScience, Inc., Hybridyne Imaging Technologies Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor localization.	Identification of tumour and/or tumour recurrence in the pelvis with imaging.	Within 2 days of imaging.