PET/MRI with 18F-DCFPyL for Prostate Cancer

Overseen By Study Coordinator

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Northwestern University

Must not be taking: Investigational agents, Radioisotopes

Disqualifiers: Prior biopsy, MRI contraindications, others

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

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a special imaging technique in diagnosing prostate cancer in men with a PSA level of 2 or higher. It uses a radioactive agent, Fluorine F 18 DCFPyL, to highlight cancer cells, combined with PET (Positron Emission Tomography) and MRI (Magnetic Resonance Imaging) scans, to better locate and understand the cancer. The goal is to determine if this method is more effective than the usual MRI scan. Men who have had a positive prostate cancer screen and plan to undergo a prostate biopsy as part of their usual care may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude patients who are receiving other treatments or investigational agents. It also excludes those who have taken a radioisotope or IV X-ray contrast medium within certain time frames before the study.

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

Research has shown that 18F-DCFPyL, a special substance used in PET scans, is generally safe for patients. Studies have found it to be well-tolerated, and it behaves in the body as expected. Importantly, 18F-DCFPyL is already approved for detecting the spread or return of prostate cancer, indicating that its safety is well-understood.

Multiparametric MRI (mpMRI) is another imaging tool used in this trial. It effectively diagnoses and assesses prostate cancer. While mpMRI is also considered safe, it can sometimes underestimate the size of more aggressive tumors.

Overall, both the PET scan with 18F-DCFPyL and the mpMRI are regarded as safe imaging techniques. They may have minor side effects, but serious risks are rare. This information helps those considering joining a clinical trial feel more informed about the safety of the procedures involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PET/MRI with 18F-DCFPyL for prostate cancer because it combines advanced imaging techniques to potentially improve cancer detection and characterization. Unlike conventional methods like standard MRI or CT scans, this approach uses a radioactive tracer, 18F-DCFPyL, to target prostate-specific membrane antigen (PSMA), which is often elevated in prostate cancer cells. This targeted method could provide clearer, more precise images, helping doctors to pinpoint cancer more accurately and choose the best treatment options. Additionally, the combination of PET and multiparametric MRI offers a comprehensive view, combining functional and anatomical details in a single session, which could streamline diagnosis and reduce the need for multiple tests.

What evidence suggests that this PET/MRI technique is effective for diagnosing prostate cancer?

Research has shown that 18F-DCFPyL is a promising tool for diagnosing prostate cancer. This imaging agent attaches to prostate cancer cells, helping doctors identify cancer locations in the body. One study found it correctly identified cancer locations in 77.8% of cases, demonstrating its effectiveness in detecting prostate cancer. In this trial, participants will receive 18F-DCFPyL as part of a PET/MRI diagnostic procedure. Another study revealed that using 18F-DCFPyL PET scans can significantly alter how doctors plan prostate cancer treatment, highlighting its strong impact on patient care. Overall, evidence indicates that 18F-DCFPyL reliably aids in detecting and understanding prostate cancer. ^{1 3 4 6 7}

Who Is on the Research Team?

Edward M Schaeffer, MD PhD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

Men with a PSA level of at least 2 ng/mL indicating potential prostate cancer, who are willing to undergo specific blood tests and biopsies as part of routine care. Participants must be over 18 years old and agree to use contraception for a day after imaging. Those with prior treatments, recent contrast medium use, past biopsies for prostate cancer, MRI contraindications like pacemakers, severely reduced kidney function or recent radioisotope administration cannot join.

Inclusion Criteria

Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

I agree to have a PHI blood test and a prostate biopsy.

Patients must agree to use adequate contraception (e.g. Barrier method of birth control; abstinence) for 24 hours following completion of imaging

Exclusion Criteria

Patients who have had a prior biopsy for prostate cancer

Patients who have contraindications to MRI (i.e. pacemakers, aneurysm clips or shaped fragments) are not eligible

I haven't had a radioisotope treatment within its 5 half-lives before my PET/MRI scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Biopsy

Participants receive fluorine F 18 DCFPyL IV and undergo PET/MRI and mpMRI, followed by TRUS guided prostate biopsy

Up to 60 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging and biopsy

30 days

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Fluorine F 18 DCFPyL
• Multiparametric Magnetic Resonance Imaging
• Positron Emission Tomography

Trial Overview

The trial is testing the effectiveness of an imaging agent called 18F-DCFPyL in PET/MRI scans for diagnosing prostate cancer severity compared to multiparametric MRI alone. The study will assess how well this new method identifies tumor location and extent in men screened positive for prostate cancer.

How Is the Trial Designed?

Group I: Diagnostic (18F-DCFPyL PET/MRI, mpMRI) Experimental Treatment 7 Interventions

Patients receive fluorine F 18 DCFPyL IV and undergo PET/MRI. Patients also receive either gadobutrol IV or gadobenate dimeglumine IV (per radiologist preference), and undergo mpMRI. Within approximately 60 days after PET/MRI and mpMRI, patients undergo TRUS guided prostate biopsy per standard of care.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The study evaluated the effectiveness of 18F-DCFPyL PET/CT in detecting recurrent prostate cancer in 77 men, showing high specificity (91%) and positive predictive value (86%) based on histologic validation.

When compared to multiparametric MRI, 18F-DCFPyL PET/CT identified significantly more pelvic lymph nodes (128 vs 23) and improved the positive predictive value by 38% overall, indicating its potential as a superior imaging tool for recurrence detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Biochemically Recurrent Prostate Cancer: Histologic Validation of 18F-DCFPyL PET/CT with Comparison to Multiparametric MRI. Lindenberg, L., Mena, E., Turkbey, B., et al.[2021]

In a study of 47 men with recurrent prostate cancer, 18F-DCFPyL PET imaging was positive in over 91% of cases, effectively identifying local and metastatic recurrences that were not detected by other imaging methods.

For patients with limited recurrence, PET-directed local ablative therapies led to a favorable PSA response in 76.9% of cases, with nearly 25% achieving a complete biochemical response, highlighting the efficacy of this targeted approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-DCFPyL (PSMA) PET in the Management of Men with Biochemical Failure after Primary Therapy: Initial Clinical Experience of an Academic Cancer Center. Metser, U., Ortega, C., Hussey, D., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

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

Initial Evaluation of [18F]DCFPyL for Prostate-Specific ...

Here we present initial safety, biodistribution, and radiation dosimetry results with [18F]DCFPyL, a second-generation fluorine-18-labeled small-molecule PSMA ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9295474/

The performance of 18F-PSMA PET/CT in the detection ...

According to the random-effects model, the DR of 18F-PSMA PET/CT was 0.83 (95% CI: 0.78–0.88) increase in the odds of the management of PCa (Figure 2a).

3.

nature.com

nature.com/articles/s41416-024-02934-x

The accuracy of fluorine 18-labelled prostate-specific ...

11.0% of patients with PI-RADS 3-5 had no PCa on biopsy, of whom 77.8% were correctly differentiated by 18F-PSMA-1007 PET/CT. Combined 18F-PSMA- ...

4.

frontiersin.org

frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1355236/full

Effect of 18 F-DCFPyL PET on changes in management ...

Conclusion: 18F-DCFPyL PET significantly affects the management of patients with prostate cancer. Higher PET positivity rate significantly ...

5.

jnm.snmjournals.org

jnm.snmjournals.org/content/61/6/881

18F-DCFPyL PET/CT Imaging in Patients with ...

The overall 18F-DCFPyL PET lesion detection rate was 77.8% (70/90), identifying one or more sites suggestive of recurrent prostate cancer.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/25896814/

Initial Evaluation of [(18)F]DCFPyL for Prostate ... - PubMed

Conclusions: [(18)F]DCFPyL is safe with biodistribution as expected, and its accumulation is high in presumed primary and metastatic foci. The radiation dose ...

7.

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. 18F-DCFPyL is ...