Prostate CancerP-PETNCT07510906
Evaluation of a Prostate-Targeted PET Imaging System (P-PET) for Detecting Prostate Cancer
A study testing Prostate-Targeted PET- Scan (P-PET). in people with Prostate Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prostate-Targeted PET- Scan (P-PET).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 30 Dec 2026to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Qualitative comparison of PET scans acquired by the P-PET vs. WB PET
Who cannot join
- Unable to comply with the length of scan time due to the study imaging.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
St. Joseph Health Care London
London, Ontario, N6A 4V2
Maureen Dougan, 519-685-8300 ext. 35352, maureen.dougan@sjhc.london.on.ca
Anna MacDonald, 519-685-8300 ext. 35352, anna.macdonald@sjhc.london.on.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Prostate-Targeted PET- Scan (P-PET).
- Keywords
- Prostate Cancer, PSMA PET Scan, Dynamic PET Scan
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Prostate-Targeted PET- Scan (P-PET). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day1)
Secondary outcomes (1)
Number of Prostate Lesions Detected by P-PET Compared with Standard-of-care Whole-Body PET
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.
Measured: Baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start30 Dec 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Lawson Research Institute of St. Joseph's
- Responsible party
- Principal investigator, Stephen Pautler, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Stephen Pautler, BSc MD FRCSC, Principal investigator, St. Joseph Health Care London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510906
- Sponsor's protocol ID
- 15142
- Acronym
- P-PET
- Status last verified
- Sep 2026
- First submitted
- 17 Mar 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Imaging Capability of a Novel Prostate-targeted PET System (P-PET) to Detect Prostate Cancer
- ClinicalTrials.gov ID
- NCT07510906
- Acronym / sponsor ID
- P-PET / 15142
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, PSMA PET Scan, Dynamic PET Scan
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Lawson Research Institute of St. Joseph's
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard-of-care PET Scan with Additional Dynamic and P-PET imaging. | Experimental | Diagnostic Test: Prostate-Targeted PET- Scan (P-PET).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. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Qualitative comparison of PET scans acquired by the P-PET vs. WB PET
Key exclusion criteria (1 listed)
- Unable to comply with the length of scan time due to the study imaging.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Standard-of-care PET Scan with Additional Dynamic and P-PET imaging. |
Primary outcome
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.
1 secondary outcome
Number of Prostate Lesions Detected by P-PET Compared with Standard-of-care Whole-Body PET
Time frame: Baseline (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen Pautler, BSc MD FRCSC principal investigator
St. Joseph Health Care London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostate-Targeted PET- Scan (P-PET). in people with Prostate Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maureen Dougan (519-685-8300 ext. 35352, maureen.dougan@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative comparison of PET scans acquired by the P-PET vs. WB PET (time frame: Baseline (Day1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.