PSMA-PET Imaging for Prostate Cancer

Overseen By Daniel Juneau, MD

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

1000 Participants Needed

Trial Summary

What is the purpose of this trial?

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. 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

What data supports the effectiveness of the drug 18F-DCFPyL IV injection, Pylarify, for prostate cancer?

Research shows that 18F-DCFPyL is better at finding prostate cancer that has spread compared to traditional imaging methods like CT scans. It is especially useful for detecting cancer in patients with high-risk or recurring prostate cancer, helping doctors make better treatment decisions. ^{1 2 3 4 5}

Is 18F-DCFPyL (Pylarify) safe for use in humans?

The safety of 18F-DCFPyL (Pylarify) has been evaluated in clinical trials like OSPREY and CONDOR, which supported its approval by the U.S. Food and Drug Administration. These trials provided evidence of its clinical utility and safety for imaging in prostate cancer patients. ^{1 3 4 6 7}

How does the drug PSMA-PET Imaging for Prostate Cancer differ from other treatments for prostate cancer?

PSMA-PET Imaging using the drug [18F]DCFPyL is unique because it targets the prostate-specific membrane antigen (PSMA), which is often overexpressed in prostate cancer cells, allowing for more precise imaging of cancer spread compared to conventional methods like CT or bone scans. This imaging technique uses a radiofluorinated compound that provides clearer images, helping in better staging and management of prostate cancer. ^{1 2 3 4 7}

Research Team

Daniel Juneau, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria

This trial is for men with prostate cancer who are being treated at CHUM and have been recommended by their doctor to get a PSMA-PET scan. It's not suitable for those who can't undergo imaging procedures due to claustrophobia or other reasons.

Inclusion Criteria

I have prostate cancer and my CHUM doctor has requested a PSMA-PET scan for me.

Exclusion Criteria

You are afraid of enclosed spaces or unable to complete imaging procedures.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PET-CT imaging following 18F-DCFPyL injection to acquire PSMA-PET data

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment using follow-up data combined with imaging for deep learning analysis

10 years

Treatment Details

Interventions

• 18F-DCFPyL IV injection

Trial Overview The study tests the use of a new PET probe called [18F]DCFPyL IV injection in detecting metastases in prostate cancer patients. It aims to combine this advanced imaging technique with deep learning to find predictive biomarkers.

Participant Groups

Group I: Main arm Experimental Treatment 1 Intervention

PET-CT imaging following 18F-DCFPyL injection, 1 injection, IV, 10 mCi

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Findings from Research

The novel PSMA-targeted PET radiotracer [(18)F]DCFPyL detected 139 sites of metastatic prostate cancer in patients, significantly outperforming conventional imaging modalities (CIM), which only identified 45 lesions.

This study suggests that [(18)F]DCFPyL PET imaging is more effective in identifying metastatic disease, especially in cases where CIM results were negative or equivocal, highlighting its potential as a superior diagnostic tool for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PSMA-Based [(18)F]DCFPyL PET/CT Is Superior to Conventional Imaging for Lesion Detection in Patients with Metastatic Prostate Cancer. Rowe, SP., Macura, KJ., Mena, E., et al.[2022]

The automated synthesis of the radiotracer [(18)F]DCFPyL for PET imaging of prostate cancer was successful, yielding a good radiochemical yield of 23% in just 55 minutes, making it suitable for clinical applications.

[(18)F]DCFPyL demonstrated high uptake in PSMA-positive LNCaP tumors, with a two-step molecular trapping mechanism confirmed, indicating its potential effectiveness for targeted imaging in prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated synthesis of [(18)F]DCFPyL via direct radiofluorination and validation in preclinical prostate cancer models. Bouvet, V., Wuest, M., Jans, HS., et al.[2020]

18F-DCFPyL (piflufolastat F 18) is the first PSMA-targeted PET agent approved for imaging prostate cancer, demonstrating high affinity for PSMA and becoming the standard-of-care for primary staging and recurrent disease.

The approval of 18F-DCFPyL was based on two significant multi-center trials, OSPREY and CONDOR, which focused on high-risk primary staging and biochemical recurrence, respectively, highlighting its efficacy in identifying prostate cancer metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image acquisition and interpretation of 18F-DCFPyL (piflufolastat F 18) PET/CT: How we do it. Rowe, SP., Voter, AF., Werner, RA., et al.[2023]

The study demonstrated that the 18F-DCFPyL PET imaging can effectively distinguish malignant prostate cancer from benign tissue, with significant differences in uptake values observed as early as 5 minutes post-injection in 10 patients with high-risk prostate cancer.

The pharmacokinetic analysis revealed that malignant prostate tissue had a 15-fold higher influx value (Ki) compared to benign prostatic hyperplasia and normal prostate tissue, indicating that 18F-DCFPyL PET imaging can be a valuable tool for early detection of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of Dynamic 18F-DCFPyL PET/CT Imaging of Prostate Adenocarcinoma in High-Risk Primary Prostate Cancer Patients. Lu, M., Lindenberg, L., Mena, E., et al.[2023]

In a study of 93 patients with biochemically recurrent prostate cancer, 18F-DCFPyL PET/CT scans identified disease in 82% of cases, significantly outperforming conventional imaging, which had an accuracy below 20%.

The use of 18F-DCFPyL PET/CT led to a change in management for 44% of patients, often shifting treatment from androgen deprivation therapy to targeted radiotherapy, highlighting its potential to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic performance of 18F-DCFPyL positron emission tomography/computed tomography for biochemically recurrent prostate cancer and change-of-management analysis. Chaussé, G., Ben-Ezra, N., Stoopler, M., et al.[2021]

The study of [(18)F]DCFPyL in nine prostate cancer patients showed that it is safe, with no major adverse events related to the radiotracer observed during the imaging process.

[(18)F]DCFPyL demonstrated high accumulation in prostate cancer sites, indicating effective targeting for imaging, and its radiation dose is comparable to other PET radiotracers, making it a viable option for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Evaluation of [(18)F]DCFPyL for Prostate-Specific Membrane Antigen (PSMA)-Targeted PET Imaging of Prostate Cancer. Szabo, Z., Mena, E., Rowe, SP., et al.[2022]

The 18F-labeled PSMA-directed PET agent [18F]DCFPyL (PYLARIFY) has shown significant clinical utility in staging and restaging prostate cancer, supported by major trials like OSPREY and CONDOR.

Following its recent FDA approval, [18F]DCFPyL is expected to see increased adoption for imaging and management of prostate cancer, enhancing image-guided treatment strategies in both the U.S. and Europe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[18F]DCFPyL PET/CT for Imaging of Prostate Cancer. Rowe, SP., Buck, A., Bundschuh, RA., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

PSMA-Based [(18)F]DCFPyL PET/CT Is Superior to Conventional Imaging for Lesion Detection in Patients with Metastatic Prostate Cancer. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Automated synthesis of [(18)F]DCFPyL via direct radiofluorination and validation in preclinical prostate cancer models. [2020]

3. Canada pubmed.ncbi.nlm.nih.gov

Image acquisition and interpretation of 18F-DCFPyL (piflufolastat F 18) PET/CT: How we do it. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A Pilot Study of Dynamic 18F-DCFPyL PET/CT Imaging of Prostate Adenocarcinoma in High-Risk Primary Prostate Cancer Patients. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

Diagnostic performance of 18F-DCFPyL positron emission tomography/computed tomography for biochemically recurrent prostate cancer and change-of-management analysis. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Initial Evaluation of [(18)F]DCFPyL for Prostate-Specific Membrane Antigen (PSMA)-Targeted PET Imaging of Prostate Cancer. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

[18F]DCFPyL PET/CT for Imaging of Prostate Cancer. [2022]