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AzTrials

Prostate CancerPhase 3NCT03594760

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

A Phase 3 study testing 18F-DCFPyL IV injection in people with Prostate Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Prostate cancer (PCa) is the most common non-skin malignancy and the third leading cause of cancer death in North American men. The accurately mapped metastatic state is a necessary prerequisite to guiding treatment in practice and in clinical trials. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
18F-DCFPyL IV injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
1 siteCanada
Study dates
1 Dec 2018to Dec 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with prostate cancer, being followed and treated at CHUM, whose treating physician at CHUM has requested a PSMA-PET scan.

Who cannot join

  • Claustrophobia/inability to complete imaging procedure.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting
  • Centre Hospitalier de l'université de Montréal

    Montreal, Quebec, H2X 0C1

    Recruiting

Other trials in Canada

About this study

Prostate cancer (PCa) is the most common non-skin malignancy and the third leading cause of cancer death in North American men. The accurately mapped metastatic state is a necessary prerequisite to guiding treatment in practice and in clinical trials. Imaging biomarkers (BMs) can provide information on disease volume and distribution, prognosis, changes in biologic behavior, therapy-induced changes (both responders and non-responders), durations of response, emergence of treatment resistance, and the host reaction to the therapies.

Of particular relevance to metastatic prostate cancer is the emergence of a promising imaging technique involving new prostate specific membrane antigen (PSMA) positron emission tomography (PET) tracers. This approach has demonstrated higher sensitivity in detecting metastases, prior to and during therapy, than current imaging standard of care (CT and bone scan), and is not widely clinically available outside of the research realm in North America.

Read more

Positron emission tomography / computer tomography (PET/CT) is a nuclear medicine diagnostic imaging procedure based on the measurement of positron emission from radiolabeled tracer molecules in vivo. PSMA is a homodimeric type II membrane metalloenzyme that functions as a glutamate carboxypeptidase/folate hydrolase and is overexpressed in PCa. PSMA is expressed in the vast majority of PCa tissue specimens and its degree of expression correlates with a number of important metrics of PCa tumor aggressiveness including Gleason score, propensity to metastasize and the development of castration resistance.

[18F]DCFPyL is a promising high-sensitivity second generation PSMA-targeted urea-based PET probe. Studies employing second-generation PSMA PET/CT imaging in men with biochemical progression after definitive therapy suggest detection of metastases in over 60% of men imaged.

Deep learning is defined as a variant of artificial neural networks, using multiple layers of 'neurons'. Deep learning has been investigated in medical imaging in numerous applications across organ systems. In oncology, basic artificial neural networks to support decision-making have previously been developed retrospectively in breast cancer and prostate cancer, but have not been validated or integrated prospectively. Novel data-driven methods are needed to predict outcomes as early as possible in order to guide the duration and the aggressiveness of a particular therapy. They are also needed for optimal patient selection based on the patient's response to a given therapy.

Here the investigators hypothesize that the combination of a highly performing prostate cancer imaging technique combined with machine learning has high potential. The main objective of this study is to acquire PSMA-PET data in patients with prostate cancer who receive treatment and follow-up in order to enable the discovery of predictive imaging biomarkers through deep learning techniques.

Conditions
Prostate Cancer
Being tested
18F-DCFPyL IV injection
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-DCFPyL IV injectionDiagnostic test

    Patient will receive one injection of 18F-DCFPyL and undergo PET-CT imaging

Study groups in NCT03594760
Study groupRoleWhat they receive
Main armExperimentalPET-CT imaging following 18F-DCFPyL injection, 1 injection, IV, 10 mCi
Receives: Diagnostic Test: 18F-DCFPyL IV injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Images from the 18F-DCFPyL PET-CT scans will be combined with patient follow-up data in a deep learning algorithm to discover radiomics features predicting outcomes (overall survival).

    Measured: 10 years

Secondary outcomes (1)
  1. Progression free survival

    Images from the 18F-DCFPyL PET-CT scans will be combined with patient follow-up data in a deep learning algorithm to discover radiomics features predicting outcomes (progression free survival).

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2018
  2. Study start1 Dec 2018
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03594760
Sponsor's protocol ID
18.068
Status last verified
Mar 2026
First submitted
9 Jul 2018
Last updated
19 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 18F-DCFPyL IV injection in people with Prostate Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Daniel Juneau, MD (1-514-890-8180, daniel.juneau@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

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