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

NCT07510906 | Not Yet Recruiting

• 1 other identifier: 15142
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; PSMA PET Scan; Dynamic PET Scan

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

• Number of Prostate Lesions Detected by P-PET Compared with Standard-of-care Whole-Body PET

  Baseline (Day 1)

Study Arms (1)

Standard-of-care PET Scan with Additional Dynamic and P-PET imaging.

EXPERIMENTAL

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).

Interventions

Prostate-Targeted PET- Scan (P-PET). DIAGNOSTIC_TEST

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.

Standard-of-care PET Scan with Additional Dynamic and P-PET imaging.

Eligibility Criteria

• Gender Eligibility Details: Men with high-risk prostate cancer eligible who will be undergoing primary staging with whole body PSMA PET/CT
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Lawson Research Institute of St. Joseph's: collaborator

Study Sites (1)

St. Joseph Health Care London

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Stephen Pautler, BSc MD FRCSC

  St. Joseph Health Care London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maureen Dougan

CONTACT

519-685-8300; maureen.dougan@sjhc.london.on.ca

Stephen Pautler, BSc MD FRCSC

CONTACT

519-646-6100; Stephen.Pautler@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study. Both participants and study staff will know that all participants are receiving clinical PSMA PET/CT, research dynamic PET, and research P-PET scans.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologist, St. Joseph's Health Care London

Model Details: All participants will first be injected with the PET radiotracer 18F-PSMA-1007. Following tracer injection, a research dynamic imaging sequence will be performed, followed by the SOC whole body PET scan. After completion of the SOC imaging, participants will undergo an additional prostate-targeted P-PET scan during the same imaging visits. This single-group design allows images from the research P-PET system to be compared with those for the standard-of-care PET scan with the same participant.

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: April 6, 2026
• Study Start (Estimated): December 30, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)