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NARECRUITING
View on ClinicalTrials.gov

Testing Ga 68 PSMA-11 PET with 18F-DCFPyL PET for advanced prostate cancer

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

Condition: Advanced Prostate CancerSponsor: University Health Network, TorontoTarget enrollment: 30

Interventions

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.

Canadian Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

RECRUITING

Eligibility Criteria

See who this study is looking for17 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Male, age ≥ 18 years
  • +High or low volume mCSPC plus PSA ≥4.0 after 6-8 months of initiating ADT
  • +Histologically or cytologically confirmed prostate cancer (adenocarcinoma)
  • +Poor risk patients with mCSPC at study enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
  • +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
  • +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 eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more →
  • +Willing to undergo study PET scans and remain under the care of medical oncology, radiation oncology or urology physician at Princess Margaret Cancer Center.

Exclusion

  • Under a randomizedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →-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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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 upFollow-upContinued check-ins after the treatment part is finished.Read more →
  • 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
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a way to identify or measure a condition.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

What is being given or done in this study: Ga 68 PSMA-11 PET, 18F-DCFPyL PET, FDG PET.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
  • armsInterventionsModule.interventions[].name
How the study is run

There is only one group in this study, so there is no assignment to different treatments.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

There is one group in this study.

From the trial registry

Built from this field:

  • armsInterventionsModule.armGroups[].type
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study lists male participants only.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 30 people.

The study is currently expected to finish around September 2029.

The main measurement is taken over: 5 years.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Proportion of patients with high volume mCSPC having PSMA avid disease — measured over 5 years.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT06335914 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Ga 68 PSMA-11 PETDiagnostic test

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

From the trial registry — its own words, unedited.

What a diagnostic test is here: A scan, blood test, or other test being studied for how well it detects or measures something.

Read the full explanation → · in clinical review

About 18F-DCFPyL PETDiagnostic test

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

From the trial registry — its own words, unedited.

What a diagnostic test is here: A scan, blood test, or other test being studied for how well it detects or measures something.

Read the full explanation → · in clinical review

About FDG PETDiagnostic test

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

From the trial registry — its own words, unedited.

What a diagnostic test is here: A scan, blood test, or other test being studied for how well it detects or measures something.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

There is only one group in this study, so there is no assignment to different treatments.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It lists male participants only.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: 5 years.

The study as a whole is currently expected to finish around 2029-09-04.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 30 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Toronto, Ontario, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

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.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.