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Recruiting

NCT Number: NCT06335914

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location status: Recruiting

Location contact

Di (Maria) Jiang, M.D.

CONTACT

[email protected]

416-946-4501 ext. 4807

Di (Maria) Jiang, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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

  • 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

Treatment and study plan

Ga 68 PSMA-11 PET

Diagnostic Test

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

18F-DCFPyL PET

Diagnostic Test

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

FDG PET

Diagnostic Test

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

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

Study contacts

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

Di (Maria) Jiang, M.D.

CONTACT

[email protected]

416-946-4501 ext. 4807

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Mar 28, 2024
Registry last updated
Feb 12, 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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