PET/MRI for Prostate Cancer

Overseen By Mary Kate Keeter, MPH

Age: 18+

Sex: Male

Trial Phase: Phase < 1

Sponsor: Northwestern University

Must not be taking: Anti-anxiety, Multivitamins

Disqualifiers: MRI contraindications, Low GFR, others

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

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special imaging technique, PET-MRI, using the substance 18F-DCFPyL (also known as PyL-PSMA-11), can enhance the diagnosis and staging of prostate cancer. The researchers aim to determine how effectively this technique reveals the cancer's extent before surgery. This trial may suit individuals diagnosed with high-risk or advanced prostate cancer who are considering surgery. As an Early Phase 1 trial, the research focuses on understanding how this new imaging technique functions in people, offering participants a chance to contribute to groundbreaking advancements in prostate cancer diagnosis.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on any other treatments or investigational agents. If you are claustrophobic, you will need to take an anti-anxiety medication before the scan.

What prior data suggests that PET/MRI using 18F-DCFPyL is safe for diagnosing prostate cancer?

Research has shown that 18F-DCFPyL is safe for use in imaging tests. Studies have found that it helps doctors detect and understand prostate cancer. Tested on many patients, it shows promise in identifying cancer that has returned. These studies have reported no serious side effects.

Additionally, the FDA has approved 18F-DCFPyL to help identify suspected spread or return of prostate cancer, indicating it has been reviewed for safety in these situations. Overall, it appears to be a well-tolerated option for imaging in 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 unique approach to imaging the disease. Unlike traditional imaging methods such as CT or standard MRI, 18F-DCFPyL is a radiotracer that specifically targets prostate-specific membrane antigen (PSMA), which is often overexpressed in prostate cancer cells. This specificity allows for more precise detection and localization of cancerous tissues, potentially leading to earlier and more accurate diagnoses. Additionally, the combination of PET and MRI provides high-resolution images, giving doctors a clearer picture of the cancer's extent, which can improve treatment planning and outcomes.

What evidence suggests that PET/MRI using 18F-DCFPyL is effective for diagnosing prostate cancer?

Research has shown that 18F-DCFPyL, which participants in this trial will receive, effectively diagnoses prostate cancer. Studies have found that it reliably identifies prostate cancer without invasive procedures. By targeting specific molecules on prostate cancer cells, 18F-DCFPyL makes the disease easier to detect. Additionally, it accurately distinguishes cancer from non-cancerous conditions. Overall, 18F-DCFPyL is a promising tool for diagnosing and understanding the stage of prostate cancer. ^{2 4 6 7 8}

Who Is on the Research Team?

Edward Schaeffer, MD/PhD

Principal Investigator

Chair, Department of Urology

Are You a Good Fit for This Trial?

This trial is for men over 18 with high risk or advanced prostate cancer, confirmed by biopsy. They must be fit enough for surgery (ECOG status 0-2) and willing to use contraception during the study. Excluded are those with poor kidney function, MRI contraindications like pacemakers, claustrophobia not managed by medication, vitamin supplements on scan day, prior prostate cancer treatments, or no interest in surgical treatment.

Inclusion Criteria

Patients must have a biopsy-proven diagnosis of high risk, very high risk, or locally advanced prostate cancer

Patients must have a diagnosis of high risk, very high risk, or locally advanced prostate cancer per NCCN Guidelines (T3-T4 disease)

Patients are healthy enough to be deemed surgical candidates with an ECOG performance status of 0-2

Exclusion Criteria

Patients with a GFR <30mL/min are ineligible to receive intravenous contrast per standard MR exclusion criteria

Patients who have contraindications to MRI (i.e. pacemakers, aneurysm clips or shaped fragments)

Patients who are claustrophobic will be required to take an anti-anxiety medication prescribed by their physician one hour prior to the scan

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo PET/MRI using 18F-DCFPyL to assess prostate cancer staging

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 18F-DCFPyL

Trial Overview The study tests PET-MRI using a tracer called 18F-DCFPyL (PyL) to improve diagnosis and staging of prostate cancer before surgery. It aims to understand how this imaging technique can better identify the extent of the disease compared to traditional methods.

How Is the Trial Designed?

Group I: 18F-DCFPyL Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Progenics Pharmaceuticals, Inc.

Industry Sponsor

Trials

35

Recruited

4,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10030046/

The diagnostic performance of 18F-DCFPyL PET in ... 18 F-DCFPyL PSMA PET has a strong predictive value for primary prostate cancer and is an effective method for the non-invasive diagnosis of prostate cancer.

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

Evaluation of 18F-DCFPyL PSMA PET/CT for Prostate ... Conclusion: 18F-DCFPyL PSMA PET/CT had good sensitivity and specificity for the diagnosis of prostate cancer. The DR of 18F-DCFPyL PSMA PET/CT ...

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

Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with ... F-DCFPyL is a small molecule that binds to the extracellular domain of PSMA with high affinity and has shown success in studies evaluating the detection of ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2020.38.15_suppl.5501

Impact of PSMA-targeted imaging with 18F-DCFPyL-PET ... The study achieved its primary endpoint: CLR of 84.8% to 87.0% among the three PyL-PET/CT readers; the LLCI for CLR by all three reviewers was > ...

5. nature.com nature.com/articles/s41598-023-35567-w

Scientific Reports 18 F]DCFPyL PET/CT is a new imaging modality to evaluate PC patients with higher sensitivity and specificity in detecting disease than other prostate specific ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6836862/

A Prospective Study on 18F-DCFPyL PSMA PET/CT ... Conclusion: 18F-DCFPyL PET/CT is safe and sensitive for the localization of biochemical recurrence of prostate cancer. This test improved decision making ...

7. 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 ...

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

18 F-DCFPyL PET/CT in Men with Prostate Cancer In 2021, 18F-DCFPyL was also approved to help identify suspected metastasis or recurrence in patients with prostate cancer. ... F-DCFPyL is ...