18F-DCFPyL PET/CT Scan for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Disqualifiers: Prior prostate biopsy, radioisotope, 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: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well a new imaging scan, called 18F-DCFPyL PET/CT, can detect significant prostate cancer. The goal is to determine if this scan can accurately identify cancer in men who might have it but haven't undergone a biopsy. Men with a PSA level between 2 and 10, planning to have a prostate biopsy, might be suitable for this trial. Participants must be ready to follow trial guidelines and sign a consent form. As a Phase 2 trial, this research focuses on measuring the imaging scan's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in prostate cancer detection.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention restrictions on recent use of radioisotopes and contrast media before the PET/CT scan.

What prior data suggests that the 18F-DCFPyL PET/CT scan is safe for detecting prostate cancer?

Research has shown that 18F-DCFPyL PET/CT is a safe imaging method for prostate cancer. In one study, 22 people experienced mild side effects after the scan, but these effects resolved completely. This indicates that the procedure is generally well-tolerated. Other studies confirm its safety and effectiveness in detecting prostate cancer. The procedure accurately identifies cancer with few false positives. Overall, 18F-DCFPyL is considered safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 18F-DCFPyL Injection for prostate cancer because it offers a new way to visualize cancer activity. Unlike traditional imaging methods, this treatment uses a radioactive tracer that specifically targets prostate-specific membrane antigen (PSMA), which is highly expressed in prostate cancer cells. This targeted approach can potentially provide clearer images and more accurate detection of cancer spread. It could lead to better treatment planning and improved outcomes for patients.

What evidence suggests that the 18F-DCFPyL PET/CT scan is effective for detecting prostate cancer?

Research has shown that the 18F-DCFPyL PET/CT scan, which participants in this trial will receive, effectively detects prostate cancer. Studies have found that it can identify returning prostate cancer even when PSA levels, a blood marker, are very low. The scan has a success rate of 79.2%, meaning it detects cancer in most cases. It is particularly useful for identifying cancer that other scans might miss, such as in the prostate area, lymph nodes, or distant parts of the body. This makes it a powerful tool for early detection of significant prostate cancer. ^{1 4 6 7 8}

Who Is on the Research Team?

Mohamad E Allaf, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

Men over 18 with a PSA level of 2-10 ng/mL, in the early clinical stages of prostate cancer (T1c-T2a), who are planning to undergo routine prostate biopsy and can give informed consent. Those who've recently had certain radiological procedures or contrast media, or have conditions that might interfere with the study, cannot participate.

Inclusion Criteria

Willingness to sign informed consent and comply with all protocol requirements

PSA of 2-10 ng/mL

I have chosen to have a prostate biopsy guided by ultrasound.

Exclusion Criteria

History of prior prostate biopsy

Administered oral contrast medium ≤120 hours prior to the date of study PET/CT

Any medical condition or other circumstances that in the opinion of the investigators compromise obtaining reliable data or achieving the study objectives

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Imaging

Participants undergo an 18F-DCFPyL PET/CT scan to identify regions of interest with radiotracer uptake

1-4 weeks

1 visit (in-person)

Biopsy

Systematic TRUS-guided prostate biopsy and fusion-targeted biopsies of PET/MRI visible lesions are performed

1-4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging and biopsy procedures

4 years

What Are the Treatments Tested in This Trial?

Interventions

• 18F-DCFPyL Injection

Trial Overview The trial is testing an injection called 18F-DCFPyL used during PET/CT scans to see how well it identifies significant prostate cancer compared to standard screening methods. It's a phase II study where participants receive this diagnostic agent before their scan.

How Is the Trial Designed?

Group I: 18F-DCFPyL Injection Experimental Treatment 1 Intervention

A bolus of \~9 mCi (333 MBq) of 18F-DCFPyL will be injected by slow IV push.

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

Progenics Pharmaceuticals, Inc.

Industry Sponsor

Trials

35

Recruited

4,400+

Published Research Related to This Trial

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]

In a study of 72 men with biochemical recurrence of prostate cancer, 18F-DCFPyL PET/CT demonstrated a high positivity rate of 85%, which increased with higher prostate-specific antigen (PSA) levels, indicating its efficacy in detecting prostate cancer lesions.

18F-DCFPyL PET/CT identified more lesions than conventional imaging methods, leading to treatment changes in 60% of patients, highlighting its potential to significantly impact clinical management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Evaluation of 18F-DCFPyL PET/CT in Biochemically Recurrent Prostate Cancer in an Academic Center: A Focus on Disease Localization and Changes in Management. Song, H., Harrison, C., Duan, H., et al.[2020]

In a study of 56 patients with suspected prostate cancer, the novel radiotracer 18F-DCFPyL demonstrated high sensitivity (90%) and specificity (100%) for detecting prostate cancer, making it a reliable diagnostic tool.

The imaging results showed a strong correlation between the radiotracer uptake (measured by SUVmax and SULmax) and serum PSA levels, indicating that 18F-DCFPyL PET/CT is effective for initial diagnosis and lymph node staging in suspected prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of 18F-DCFPyL PET/CT in patients with suspected prostate cancer. Zhang, T., Yang, S., Lin, L., et al.[2022]

In a study of 130 subjects with biochemical recurrence of prostate cancer, 18F-DCFPyL PET/CT imaging successfully localized recurrent cancer in up to 92% of cases with higher PSA levels, demonstrating its sensitivity as a diagnostic tool.

The use of 18F-DCFPyL PET/CT significantly impacted patient management, with 87.3% of subjects experiencing changes in their treatment plans, indicating its effectiveness in guiding oncologists' decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective Study on 18F-DCFPyL PSMA PET/CT Imaging in Biochemical Recurrence of Prostate Cancer. Rousseau, E., Wilson, D., Lacroix-Poisson, F., 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 ... This study was designed to evaluate the performance of 18F-DCFPyL-PET/CT in prostate cancer patients with BCR and non-informative standard-of-care imaging.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.344

Early detection of recurrent prostate cancer using 18F ... 18F-DCFPyL PET/CT demonstrates high detection rate for recurrent prostate cancer even in patients with minimally detectable PSA levels.

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

Evaluation of 18F-DCFPyL PSMA PET/CT for Prostate ... In summary, the 18F-DCFPyL PET/CT method had high efficiency in diagnosing prostate cancer. CT and MRI were useful non-invasive methods for ...

4. mdpi.com mdpi.com/2072-6694/17/8/1272

Diagnostic Capability and Improved Clinical Management ... The study demonstrated the ability of 18F-DCFPyL PET/CT to detect previously unsuspected disease in the prostate bed, lymph nodes, and distant metastases, ...

5. jnm.snmjournals.org jnm.snmjournals.org/content/63/8/1184

Predictors of 18F-DCFPyL PET/CT Positivity in Patients with ... The overall 18F-DCFPyL PET/CT positivity rate was 79.2%, with a detection rate of 48.2% at a PSA of less than 0.5 ng/mL, in line with previous ...

6. 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 ...

7. jnm.snmjournals.org jnm.snmjournals.org/content/60/11/1587

A Prospective Study on 18 F-DCFPyL PSMA PET/CT Imaging ... Twenty-two subjects reported mild adverse events after the scan; all resolved completely. Conclusion: 18F-DCFPyL PET/CT is safe and sensitive ...

8. nature.com nature.com/articles/s41391-022-00534-5

The differential diagnostic value of dual-phase 18 F- ... Uptake of 18F-DCFPyL increased over time in prostate-associated malignant lesions compared with benign tissue. For single-phase imaging, 2-hour ...