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RecruitingNCT06335914Updated Feb 12, 2026

Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer

An interventional study of Ga 68 PSMA-11 PET and 18F-DCFPyL PET in Advanced Prostate Cancer, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-12.

Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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. This may help with treatment selection and potential response monitoring in the future.

02

Conditions studied

  • Advanced Prostate Cancer

Keywords

  • Prostate Specific Membrane Antigen
  • Positron Emission Tomography
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In context

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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

    • another active malignancy
    • patient on dialysis
    • another radioisotope or investigational systemic agent within 5 half-lives prior to PET imaging
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    PSMA and FDG PET Imaging

    Participants advanced prostate cancer will undergo PSMA and FDG PET prior to starting their standard of care treatment and during treatment.

    Diagnostic Test: Ga 68 PSMA-11 PET · Diagnostic Test: 18F-DCFPyL PET · Diagnostic Test: FDG PET

Interventions

  • Diagnostic testGa 68 PSMA-11 PET

    Positron emission tomography (PET) imaging using Ga68 PSMA 11 radiotracer

  • Diagnostic test18F-DCFPyL PET

    Positron emission tomography (PET) imaging using 18F-DCFPyL radiotracer.

  • Diagnostic testFDG PET

    Positron emission tomography (PET) imaging using (18) F-fluorodeoxyglucose radiotracer.

06

What researchers measure

Primary outcomes

  1. Proportion of patients with high volume mCSPC having PSMA avid disease

    Time frame: 5 years

Secondary outcomes

  1. Proportion of patients with PSMA-/FDG+ discordant lesions

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Princess Margaret Cancer Centre
    Toronto, Ontario M5G 2M9, Canada
    • Di (Maria) Jiang, M.D. · Contact · di.jiang@uhn.ca · 416-946-4501
    • Di (Maria) Jiang, M.D. · Principal investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06335914
Lead sponsor
University Health Network, Toronto
Responsible party
Sponsor
First posted
Mar 28, 2024
Start date
Apr 3, 2025
Primary completion
Mar 4, 2029 (estimated)
Completion
Sep 4, 2029 (estimated)
Last update
Feb 12, 2026

Study contacts

Di (Maria) Jiang, M.D.
Contact
di.jiang@uhn.ca
416-946-4501 ext. 4807
Di (Maria) Jiang
principal investigator · Princess Margaret Cancer Centre/University Health Network

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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