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

March 21, 2024 updated by: University Health Network, Toronto
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Di (Maria) Jiang, M.D.
  • Phone Number: 4807 416-946-4501
  • Email: di.jiang@uhn.ca

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
        • Contact:
          • Di (Maria) Jiang, M.D.
          • Phone Number: 4807 416-946-4501
          • Email: di.jiang@uhn.ca
        • Principal Investigator:
          • Di (Maria) Jiang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Positron emission tomography (PET) imaging using Ga68 PSMA 11 radiotracer
Diagnostic test: 18F-DCFPyL PET
Positron emission tomography (PET) imaging using 18F-DCFPyL radiotracer.
Diagnostic test: FDG PET
Positron emission tomography (PET) imaging using (18) F-fluorodeoxyglucose radiotracer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with high volume mCSPC having PSMA avid disease
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with PSMA-/FDG+ discordant lesions
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Di (Maria) Jiang, Princess Margaret Cancer Centre/University Health Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

March 4, 2029

Study Completion (Estimated)

September 4, 2029

Study Registration Dates

First Submitted

March 21, 2024

First Submitted That Met QC Criteria

March 21, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • dualPET-mPC
  • CAPCR: 23-5595 (Other Identifier: University Health Network)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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