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NCT Number: NCT07510906

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Maureen Dougan

CONTACT

[email protected]

519-685-8300 ext. 35352

Stephen Pautler, BSc MD FRCSC

CONTACT

[email protected]

519-646-6100 ext. ext. 66384

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Lawson Research Institute of St. Joseph's

Registry information

Official study title

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

Acronym: P-PET

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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