Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
ID06335914

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

Led by University Health Network, Toronto · Updated on 2026-02-12

30

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying advanced prostate cancer using two types of PET imaging: Prostate Specific Membrane Antigen (PSMA) and (18)F-Fluorodeoxyglucose (FDG) PET scans. The goal is to learn about tumor biology at different disease stages and during treatment, which may help guide future treatment choices and monitor how well treatments work. This study is interventional and sponsored by the University Health Network in Toronto. Participants with advanced prostate cancer will undergo PSMA and FDG PET scans before starting their standard care treatment and again during treatment. The scans use specialized radiotracers including Ga 68 PSMA-11 and 18F-DCFPyL for PSMA imaging and FDG for glucose metabolism imaging. The imaging will help assess tumor activity and changes over time. The study includes monitoring at multiple time points. During the study, participants will receive PET imaging exams and continue their usual care under oncology or urology doctors. Researchers will measure the proportion of patients with high volume metastatic castration-sensitive prostate cancer (mCSPC) showing PSMA active disease over five years. They will also evaluate the presence of discordant lesions between PSMA and FDG imaging. Participants will be monitored for safety and imaging results throughout the study period, which lasts at least five years.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male, age 18 years or older
  • Histologically or cytologically confirmed prostate cancer (adenocarcinoma)
  • Poor risk patients with metastatic castration-sensitive prostate cancer (mCSPC) at enrollment
  • De novo or recurrent high volume mCSPC as per conventional imaging before starting ADT and ARPI
  • High or low volume mCSPC with PSA level ≤4.0 after 6-8 months of starting ADT
  • Willing to undergo study PET scans and remain under care of oncology or urology physician at Princess Margaret Cancer Center
  • No prior PSMA or FDG PET imaging within 60 days at each study time point
  • Patients enrolled in other clinical trials are eligible if they meet all other criteria
Not Eligible

You will not qualify if you...

  • Participation in a randomized-controlled trial with unknown systemic therapy allocation
  • Inability to undergo or complete PSMA PET and FDG PET imaging exams
  • Unable to provide written consent personally or by legal representative
  • Conditions impairing ability to comply with study procedures or follow-up, as judged by physician
  • Significant uncontrolled health issues affecting safety or imaging interpretation
  • Another active malignancy
  • Patient on dialysis
  • Use of another radioisotope or investigational systemic agent within 5 half-lives before PET imaging

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 week

Participants undergo PSMA and FDG PET imaging before starting their standard of care treatment.

1 to 2 imaging visits

Long-term Monitoring

Duration - Up to 5 years

Participants are monitored with follow-up PSMA and FDG PET imaging during treatment and over time to assess disease status.

Periodic imaging visits depending on treatment schedule

Trial Site Locations

Total: 1 location

1

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

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Research Team

D

Di (Maria) Jiang, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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