Advanced Prostate CancerNCT06335914
Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer
A study testing Ga 68 PSMA-11 PET, 18F-DCFPyL PET and FDG PET in people with Advanced Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This study will use Prostate Specific Membrane Antigen (PSMA) and (18)F-Fluorodeoxyglucose Positron Emission Tomography (FDG PET) imaging in patients with advanced prostate cancer to learn about tumor biology across disease stages and during treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Advanced Prostate Cancer
- What is being tested?
- Ga 68 PSMA-11 PET, 18F-DCFPyL PET and FDG PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 3 Apr 2025to 4 Sep 2029
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, age ≥ 18 years
- Histologically or cytologically confirmed prostate cancer (adenocarcinoma)
- Poor risk patients with mCSPC at study enrollment
- De novo or recurrent high volume mCSPC as per conventional imaging (CT chest abdomen pelvis, or MRI, plus bone scan) prior to starting ADT and ARPI
- High or low volume mCSPC plus PSA ≥4.0 after 6-8 months of initiating ADT
- Willing to undergo study PET scans and remain under the care of medical oncology, radiation oncology or urology physician at Princess Margaret Cancer Center.
- No prior PSMA or FDG PET imaging within the last 60 days at each specified time point on study
- Patients enrolled in clinical trials are eligible if they satisfy all other criteria of eligibility
Who cannot join
- Under a randomized-controlled trial with unknown allocation of systemic therapy
- Inability to undergo or successfully complete PSMA PET and FDG PET imaging exams
- Unable to provide written consent by patient and their legal representatives
- In the opinion of the treating physician:
- conditions which would significantly impair the patient's ability to comply with study procedures and follow up
- Significant uncontrolled comorbidity, which may negatively impact the safety or interpretability of study PET imaging
Show all 9Show fewer
- another active malignancy
- patient on dialysis
- another radioisotope or investigational systemic agent within 5 half-lives prior to PET 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, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Di (Maria) Jiang, M.D., 416-946-4501 ext. 4807, di.jiang@uhn.ca
Di (Maria) Jiang, M.D.
About this study
This study will use Prostate Specific Membrane Antigen (PSMA) and (18)F-Fluorodeoxyglucose Positron Emission Tomography (FDG PET) imaging in patients with advanced prostate cancer to learn about tumor biology across disease stages and during treatment. This may help with treatment selection and potential response monitoring in the future.
- Conditions
- Advanced Prostate Cancer
- Being tested
- Ga 68 PSMA-11 PET, 18F-DCFPyL PET, FDG PET
- Keywords
- Prostate Specific Membrane Antigen, Positron Emission Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ga 68 PSMA-11 PETDiagnostic test
Positron emission tomography (PET) imaging using Ga68 PSMA 11 radiotracer
18F-DCFPyL PETDiagnostic test
Positron emission tomography (PET) imaging using 18F-DCFPyL radiotracer.
FDG PETDiagnostic test
Positron emission tomography (PET) imaging using (18) F-fluorodeoxyglucose radiotracer.
| Study group | Role | What they receive |
|---|---|---|
| PSMA and FDG PET Imaging | Experimental | Participants advanced prostate cancer will undergo PSMA and FDG PET prior to starting their standard of care treatment and during treatment. Receives: Diagnostic Test: Ga 68 PSMA-11 PET; Diagnostic Test: 18F-DCFPyL PET; Diagnostic Test: FDG PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with high volume mCSPC having PSMA avid disease
Measured: 5 years
Secondary outcomes (1)
Proportion of patients with PSMA-/FDG+ discordant lesions
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start3 Apr 2025
- Primary completion4 Mar 2029 (estimated)
- Study completion4 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Di (Maria) Jiang, Principal investigator, Princess Margaret Cancer Centre/University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335914
- Sponsor's protocol ID
- dualPET-mPC
- Other IDs
- CAPCR: 23-5595
- Status last verified
- Feb 2026
- First submitted
- 21 Mar 2024
- Last updated
- 12 Feb 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 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT06335914
- Acronym / sponsor ID
- dualPET-mPC
- Conditions
- Advanced Prostate Cancer
- Keywords
- Prostate Specific Membrane Antigen, Positron Emission Tomography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 4 Mar 2029 (estimated)
- Study completion
- 4 Sep 2029 (estimated)
- First posted
- 28 Mar 2024 (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.
This study will use Prostate Specific Membrane Antigen (PSMA) and (18)F-Fluorodeoxyglucose Positron Emission Tomography (FDG PET) imaging in patients with advanced prostate cancer to learn about tumor biology across disease stages and during treatment. This may help with treatment selection and potential response monitoring in the future.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSMA and FDG PET Imaging | Experimental | Diagnostic Test: Ga 68 PSMA-11 PET, Diagnostic Test: 18F-DCFPyL PET, Diagnostic Test: FDG PETParticipants advanced prostate cancer will undergo PSMA and FDG PET prior to starting their standard of care treatment and during treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male, age ≥ 18 years
- Histologically or cytologically confirmed prostate cancer (adenocarcinoma)
- Poor risk patients with mCSPC at study enrollment
- De novo or recurrent high volume mCSPC as per conventional imaging (CT chest abdomen pelvis, or MRI, plus bone scan) prior to starting ADT and ARPI
- High or low volume mCSPC plus PSA ≥4.0 after 6-8 months of initiating ADT
Key exclusion criteria (9 listed)
- Under a randomized-controlled trial with unknown allocation of systemic therapy
- Inability to undergo or successfully complete PSMA PET and FDG PET imaging exams
- Unable to provide written consent by patient and their legal representatives
- In the opinion of the treating physician:
- conditions which would significantly impair the patient's ability to comply with study procedures and follow up
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 |
|---|---|---|
| Ga 68 PSMA-11 PETPositron emission tomography (PET) imaging using Ga68 PSMA 11 radiotracer | Diagnostic test | PSMA and FDG PET Imaging |
| 18F-DCFPyL PETPositron emission tomography (PET) imaging using 18F-DCFPyL radiotracer. | Diagnostic test | PSMA and FDG PET Imaging |
| FDG PETPositron emission tomography (PET) imaging using (18) F-fluorodeoxyglucose radiotracer. | Diagnostic test | PSMA and FDG PET Imaging |
Primary outcome
Proportion of patients with high volume mCSPC having PSMA avid disease
Time frame: 5 years
1 secondary outcome
Proportion of patients with PSMA-/FDG+ discordant lesions
Time frame: 5 years
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 12 Feb 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.
Di (Maria) Jiang principal investigator
Princess Margaret Cancer Centre/University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ga 68 PSMA-11 PET, 18F-DCFPyL PET and FDG PET in people with Advanced Prostate Cancer, run by University Health Network, Toronto 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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 12 Feb 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 Di (Maria) Jiang, M.D. (416-946-4501 ext. 4807, di.jiang@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with high volume mCSPC having PSMA avid disease (time frame: 5 years). 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 12 Feb 2026.