Evaluation of a Prostate-Targeted PET Imaging System (P-PET) for Detecting Prostate Cancer (P-PET)

March 31, 2026 updated by: Stephen Pautler, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

A Pilot Study to Evaluate the Imaging Capability of a Novel Prostate-targeted PET System (P-PET) to Detect Prostate Cancer

The goal of this study is to evaluate the imaging capabilities of a new prostate-targeted PET system (P-PET) and determine whether it could be useful in detecting prostate cancer by comparing SOC whole body PET imaging. This pilot study will include adult men who have been diagnosed with or are suspected to have prostate cancer. Participants will undergo a standard-of-care PET/CT scan followed by an additional P-PET scan designed to provide detailed images of the prostate. The images from the two scans to assess how well the P-PET system can detect prostate cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This pilot study will evaluate the performance of a novel prostate-targeted positron emission tomography (PET) imaging system (P-PET) in men undergoing PET imaging for primary staging of prostate cancer. This study is designed to assess the feasibility and diagnostic performance of this new imaging approach.

Participants will receive the standard-of-care PET radiotracer fluroine-18 PSMA-1007 (18F-PSMA-1007) as part of routine clinical PET imaging. While the tracer is circulating in the body, a research dynamic imaging sequence will be performed, followed by the standard-of-care whole body PET scan. Immediately after completion of the standard imaging, participants will undergo the research P-PET scan during the same imaging visit. No additional radiotracer will be administered for the P-PET scan, as it used the same tracer injection given for the standard-of-care PET imaging.

Images obtained from the P-PET system will undergo comparative analysis with the standard-of-care PET scan images to assess lesion detection, image quality and overall imaging performance. The findings from this study will provide preliminary data on feasibility and potential diagnostic value of the P-PET system and may guide future research in prostate-targeted PET imaging.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Qualitative comparison of PET scans acquired by the P-PET vs. WB PET

Exclusion Criteria:

  • Unable to comply with the length of scan time due to the study imaging.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard-of-care PET Scan with Additional Dynamic and P-PET imaging.
This is a prospective, single-arm, pilot diagnostic study to evaluate the diagnostic study to evaluate the diagnostic accuracy of using dynamic PET, and P-PET in 25 patients with biopsy proven prostate cancer. This study will take place during the scheduled routine clinical PSMA PET/CT scan.
Diagnostic test: Prostate-Targeted PET- Scan (P-PET).
Participants will undergo a prostate-targeted PET scan to detect prostate cancer. This research scan is performed after the standard-of-care PET scan to evaluate its imaging capability. While the radioisotope is still active.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative comparison of PET scans acquired by the P-PET vs. WB PET
Time Frame: Baseline (Day1)
The primary outcome is the detection of prostate cancer lesions by the research prostate-targeted P-PET scan. Images from the P-PET scan will be compared to standard-of-care PET scan images to evaluate the sensitivity and clarity of the new imaging system in identifying cancerous lesions in the prostate.
Baseline (Day1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Prostate Lesions Detected by P-PET Compared with Standard-of-care Whole-Body PET
Time Frame: Baseline (Day 1)
The number of pelvic lesions detected by P-PET in comparison with the number of lesions detected by standard-of-care whole body PET/CT.
Baseline (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Collaborators

Lawson Research Institute of St. Joseph's

Investigators

  • Principal Investigator: Stephen Pautler, BSc MD FRCSC, St. Joseph Health Care London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15142

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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