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

106 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well 18F-DCFPyL positron emission tomography (PET)/magnetic resonance imaging (MRI) works for the diagnosis of prostate cancer in men with a PSA greater than or equal to 2 ng/mL. 18F-DCFPyl is a radioactive injectable imaging agent made of a prostate specific membrane antigen (PSMA) that attaches to tumor cells, which makes it useful for the diagnosis of prostate cancer. A PET scan is an imaging tool that may help find the location of cancer, by using a radioactive drug and a computer to create images of how organs and tissues in the body are functioning. A mp-MRI is used to help determine the extent of a patient's cancer. A MRI scan uses strong magnets and computers to create detailed images of the soft tissue in the body. This trial aims to compare PET scans to prostate specific mp-MRI to evaluate prostate cancer severity in men with a positive screen for prostate cancer.

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 data supports the effectiveness of the treatment 18F-DCFPyL PET/MRI for prostate cancer?

Research shows that 18F-DCFPyL PET/MRI is effective in detecting prostate cancer, especially in identifying lymph node and bone metastases, with better diagnostic performance compared to traditional MRI. It has high specificity and positive predictive value, meaning it is good at correctly identifying cancer when it is present. ^{1 2 3 4 5}

Is 18F-DCFPyL PET/MRI safe for humans?

The studies mention the use of 18F-DCFPyL PET/MRI for prostate cancer detection and diagnosis, but they do not provide specific safety data. However, 18F-DCFPyL is a prostate-specific membrane antigen (PSMA) ligand that has been approved by the FDA, suggesting it has undergone safety evaluations. ^{1 2 3 5 6}

How does the treatment 18F-DCFPyL PET/MRI differ from other prostate cancer treatments?

18F-DCFPyL PET/MRI is unique because it combines a special imaging agent, 18F-DCFPyL, with MRI to better detect prostate cancer, especially in lymph nodes and bones, compared to traditional MRI alone. This method provides more accurate and confident diagnosis, which can be crucial for treatment planning. ^{1 2 3 4 5}

Research Team

Edward M Schaeffer, MD PhD

Principal Investigator

Northwestern University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Prospective analysis of clinically significant prostate cancer detection with [18F]DCFPyL PET/MRI compared to multiparametric MRI: a comparison with the histopathology in the radical prostatectomy specimen, the ProStaPET study. [2022]

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

PSMA-based 18F-DCFPyL PET: a better choice than multiparametric MRI for prostate cancer diagnosis? [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Detection of clinically significant prostate cancer with 18F-DCFPyL PET/multiparametric MR. [2021]

4. Switzerland 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. [2021]

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

Evaluating Biochemically Recurrent Prostate Cancer: Histologic Validation of 18F-DCFPyL PET/CT with Comparison to Multiparametric MRI. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

[18F]DCFPyL PET/CT versus [18F]fluoromethylcholine PET/CT in Biochemical Recurrence of Prostate Cancer (PYTHON): a prospective, open label, cross-over, comparative study. [2023]