PSMA-PET Imaging for Prostate Cancer

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging method called PSMA-PET to better detect the spread of prostate cancer. It uses a special tracer, [18F]DCFPyL (also known as Pylarify), which may reveal more about cancer's location and behavior than current scans. The trial also aims to use machine learning, a type of artificial intelligence, to identify patterns that might predict treatment effectiveness. Men with prostate cancer undergoing treatment at CHUM, whose doctors have requested this scan, might be suitable candidates. Participants must complete the imaging process without issues like claustrophobia. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking advancement in prostate cancer detection.

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 prior data suggests that this imaging technique is safe for prostate cancer patients?

Research has shown that the 18F-DCFPyL injection, used for PSMA-PET imaging, is generally safe for people. Studies have found that this imaging agent is well-tolerated and behaves as expected in the body. The tracer tends to gather in areas where prostate cancer might be present. Based on available data, no major safety concerns have been identified with its use.

Side effects are usually mild. Some people might experience minor reactions related to the injection itself, but strong evidence of serious reactions is lacking. The safety profile resembles that of other imaging procedures using radioactive tracers. This suggests the injection is safe for use in clinical settings, especially for detecting the spread of prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 18F-DCFPyL for prostate cancer because it offers a new way to visualize cancer cells using PSMA-PET imaging. Unlike traditional imaging methods like CT or MRI, which can sometimes miss small or hidden tumors, PSMA-PET imaging with 18F-DCFPyL targets a protein that's highly expressed on prostate cancer cells, potentially leading to more accurate detection. This could help doctors better assess the extent of the disease and tailor treatments more effectively.

What evidence suggests that PSMA-PET imaging is effective for prostate cancer?

Research has shown that 18F-DCFPyL PET/CT, which participants in this trial will undergo, is a highly effective imaging tool for detecting prostate cancer. This method excels at identifying cancer even when PSA (prostate-specific antigen) levels are low. PSA serves as a marker for monitoring prostate cancer. Compared to standard imaging methods like CT scans or bone scans, 18F-DCFPyL PET/CT is superior, particularly in identifying aggressive cancer types. Some studies found that this technique has a sensitivity of about 92%, making it a reliable choice for detecting cancer spread. It aids doctors in planning better treatments by providing a clearer view of the cancer's extent. ^{6 7 8 9 10}

Who Is on the Research Team?

Daniel Juneau, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8382991/

Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with ... These data support 18F-DCFPyL-PET/CT as a safe and robust imaging tool to reliably detect recurrent prostate cancer, even at low PSA levels, thus providing new ...

2. pylarify.com pylarify.com/efficacy-safety/diagnostic-performance

Learn About Diagnostic Performance for PYLARIFY® PYLARIFY is a PSMA-targeted PET imaging agent for prostate cancer. Explore the clinical study results to learn more about the diagnostic performance.

3. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2020.597422/full

Evaluation of 18F-DCFPyL PSMA PET/CT for Prostate ... This study showed that 18F-DCFPyL PET/CT had high sensitivity and specificity for the diagnosis of prostate cancer. At present, with the ...

4. auntminnie.com auntminnie.com/clinical-news/molecular-imaging/article/15633493/psmapetct-is-costeffective-over-standard-prostate-cancer-imaging

PSMA-PET/CT is cost-effective over standard prostate ... "F-18 DCFPyL PET/CT was associated with a higher QALY than [F-18 fluciclovine] PET, and improved detection of aggressive disease relative to conventional ...

5. spandidos-publications.com spandidos-publications.com/10.3892/ol.2024.14321

Diagnostic performance of 18 F‑DCFPyL PET vs. 68 Ga ... Based on the results, 18F-DCFPyL PET demonstrated a pooled sensitivity, specificity and AUC of 0.92, 0.59 and 0.92, respectively. 68Ga-PSMA PET/ ...

6. pylarify.com pylarify.com/efficacy-safety/safety

Explore PYLARIFY® Safety Data & Side Effects PYLARIFY is a PSMA-targeted PET imaging agent for prostate cancer. Learn more about PYLARIFY safety data and adverse reactions.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/214793s000lbl.pdf

PYLARIFY® (piflufolastat F 18) injection, for intravenous use PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4531836/

Initial Evaluation of [18F]DCFPyL for Prostate-Specific ... [18F]DCFPyL is safe with biodistribution as expected, and its accumulation is high in presumed primary and metastatic foci. The radiation dose from [18F]DCFPyL ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03739684

NCT03739684 | Study of 18F-DCFPyL PET/CT Imaging in ... This study evaluates the diagnostic performance and safety of 18F-DCFPyL (PyL) PET/CT imaging in patients with suspected recurrence of prostate cancer who ...

10. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.221536

18 F-DCFPyL PET/CT in Men with Prostate Cancer F-DCFPyL PET may be helpful for primary staging in the setting of men with high-risk prostate cancer or in the work-up of men with prostate ...