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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a phase II, single-center, open-label, trial to evaluate the diagnostic accuracy of PSMA-targeted 18F-DCFPyL PET/CT for detecting clinically significant prostate cancer in a screening population.

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 data supports the effectiveness of the drug 18F-DCFPyL Injection for prostate cancer?

Research shows that 18F-DCFPyL PET/CT scans are effective in detecting recurrent prostate cancer, with a high positivity rate and the ability to find more cancer lesions than other imaging methods. This helps doctors make better treatment decisions, changing management plans for many patients. ^{1 2 3 4 5}

Is the 18F-DCFPyL PET/CT scan safe for humans?

The 18F-DCFPyL PET/CT scan is generally safe for humans, with mild adverse events reported in some cases, all of which resolved completely. ^{2 3 4 5 6}

How does the 18F-DCFPyL PET/CT scan differ from other treatments for prostate cancer?

The 18F-DCFPyL PET/CT scan is unique because it uses a special radiotracer that targets the prostate-specific membrane antigen (PSMA), allowing it to detect prostate cancer recurrences more accurately than conventional imaging methods. This scan can identify cancer even at low PSA levels, leading to changes in treatment plans for many patients. ^{2 4 5 6 7}

Research Team

Mohamad E Allaf, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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 am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

References

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

Diagnostic Performance of PSMA-Based 18 F-DCFPyL PET/CT in Prostate Cancer Patients After Definitive Treatment With PSA Level ≤0.2 ng/mL. [2023]

2. 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]

3. 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]

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

A Prospective Study on 18F-DCFPyL PSMA PET/CT Imaging in Biochemical Recurrence of Prostate Cancer. [2020]

5. United States 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. [2020]

6. Greece pubmed.ncbi.nlm.nih.gov

Role of 18F-DCFPyL PET/CT in patients with suspected prostate cancer. [2022]

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

Prospective Evaluation of PSMA-Targeted 18F-DCFPyL PET/CT in Men with Biochemical Failure After Radical Prostatectomy for Prostate Cancer. [2022]