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

ConditionAdvanced Prostate Cancer

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexMale

Age18+

SponsorUniversity Health Network, Toronto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

conditions which would significantly impair the patient's ability to comply with study procedures and follow up

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: PSMA and FDG PET ImagingExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

Proportion of patients with high volume mCSPC having PSMA avid disease

Time frame

5 years

Secondary outcomes

Proportion of patients with PSMA-/FDG+ discordant lesions

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov

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