18F-DCFPyL PET/CT Imaging for Prostate Cancer

Overseen By Yolanda McKinney, R.N.

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Disqualifiers: Severe claustrophobia, Weight > 350 lbs, 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: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging method to detect prostate cancer using a special radiotracer called 18F-DCFPyL. The aim is to determine if this tracer can better identify prostate cancer in men at high risk of cancer spreading or showing signs of recurrence after initial treatment, such as surgery or radiation. The trial seeks men with newly diagnosed high-risk prostate cancer or those whose cancer appears to be returning after previous treatments. Participants will undergo scans and possibly MRIs to help doctors more clearly understand the cancer's spread or return. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that 18F-DCFPyL PET/CT imaging is safe for prostate cancer patients?

Research has shown that 18F-DCFPyL PET/CT is a safe imaging tool for detecting prostate cancer. Studies have found it to be well-tolerated by patients with a good safety record. One study highlighted its ability to safely and accurately detect recurring prostate cancer. Another study confirmed its safety and effectiveness in identifying cancer even when PSA (prostate-specific antigen) levels are low.

Previous research has not reported significant side effects from using 18F-DCFPyL in imaging, indicating that participants generally did not experience serious issues. This radiotracer, injected into the bloodstream, helps doctors identify potential cancer locations.

While researchers continue to test this imaging method, current data suggest it is a safe option for patients with prostate cancer concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 18F-DCFPyL PET/CT imaging technique for prostate cancer because it offers a more precise way to detect cancerous cells. Unlike traditional imaging methods, which might miss smaller or less active tumors, 18F-DCFPyL is a radiotracer that specifically targets the PSMA (Prostate-Specific Membrane Antigen) found on prostate cancer cells, allowing for clearer and more accurate imaging. This can lead to better-informed treatment decisions, potentially improving patient outcomes by identifying cancer recurrence earlier and more accurately.

What evidence suggests that 18F-DCFPyL PET/CT imaging is effective for identifying prostate cancer?

Studies have shown that 18F-DCFPyL PET/CT effectively diagnoses prostate cancer. This method reliably predicts cancer, accurately identifying both the presence and spread of returning prostate cancer. The trial will evaluate 18F-DCFPyL PET/CT imaging in various contexts, such as biochemical recurrence and localized high-risk prostate cancer, aiding doctors in creating better treatment plans. Additionally, 18F-DCFPyL PET/CT surpasses other imaging methods in correctly identifying those with and without the disease, making it a promising tool for managing prostate cancer effectively. ^{2 3 6 7 8}

Who Is on the Research Team?

Peter L Choyke, M.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

Men 18+ with prostate cancer either newly diagnosed as high risk or showing signs of recurrence after treatment. They must be able to consent, agree to use contraception, and fit within the scanner's weight limit. Exclusions include severe claustrophobia, conditions that could affect results, excessive serum creatinine levels, or if participation delays standard care.

Inclusion Criteria

I agree to use effective birth control during and for 2 months after the study.

I can take care of myself and am up and about more than half of my waking hours.

My prostate cancer was confirmed through a tissue examination.

Exclusion Criteria

Serum creatinine greater than 2 times the upper limit of normal

Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results

I have severe claustrophobia that doesn't improve with anxiety medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo 18F-DCFPyL injection and whole body PET/CT imaging

1 day

1 visit (in-person)

Follow-up

Participants are monitored for PSA relapse and radiologic evidence of metastatic disease

4 years

Yearly follow-up via chart review, phone-call, email or other NIH approved platform

Optional Imaging Extension

Additional 18F-DCFPyL PET/CT might be performed during follow-up if there is a considerable change in patient status

What Are the Treatments Tested in This Trial?

Interventions

• 18F-DCFPyL
• 18F-FDG
• PSMA-11

Trial Overview

The trial is testing a radiotracer called 18F-DCFPyL for detecting prostate cancer in high-risk or recurrent cases. Participants will undergo scans using this tracer and may have additional MRI scans and biopsies. The study aims to improve imaging techniques for better diagnosis and management of prostate cancer.

How Is the Trial Designed?

Group I: 2/biochemical recurrence (bcr) Experimental Treatment 3 Interventions

18F-DCFPyL PET/CT imaging, unlabeled PSMA-11 (optional)

Group II: 1/Localized High Risk Experimental Treatment 2 Interventions

18F-DCFPyL PET/CT imaging, unlabeled PSMA-11 (optional) and possible prostatectomy

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study involving 10 patients with newly diagnosed prostate cancer, the novel PET tracer 18F-PSMA-7Q demonstrated comparable imaging characteristics to the FDA-approved tracer 18F-DCFPyL, with both detecting 17 lesions without significant differences in uptake values.

18F-PSMA-7Q showed limited urinary excretion, which may provide an advantage for detecting pelvic lesions, suggesting it could be a promising alternative for prostate cancer imaging pending further validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective intraindividual comparison of 18F-PSMA-7Q and 18F-DCFPyL PET/CT in patients with newly diagnosed prostate cancer. Liu, Y., Zhang, X., Liu, J., et al.[2023]

The study evaluated the dosimetry of the PET radiotracer 18F-DCFPyL in nine patients with metastatic prostate cancer, revealing that the lacrimal glands received the highest absorbed dose, which is important for understanding potential side effects during imaging and therapy.

Using advanced Monte-Carlo models, the research provided new insights into the dose received by the lacrimal and salivary glands, which are critical for assessing the safety and efficacy of 18F-DCFPyL in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined model-based and patient-specific dosimetry for 18F-DCFPyL, a PSMA-targeted PET agent. Plyku, D., Mena, E., Rowe, SP., et al.[2018]

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]

The 18F-labeled PSMA-directed PET agent [18F]DCFPyL (PYLARIFY) has shown significant clinical utility in staging and restaging prostate cancer, supported by major trials like OSPREY and CONDOR.

Following its recent FDA approval, [18F]DCFPyL is expected to see increased adoption for imaging and management of prostate cancer, enhancing image-guided treatment strategies in both the U.S. and Europe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[18F]DCFPyL PET/CT for Imaging of Prostate Cancer. Rowe, SP., Buck, A., Bundschuh, RA., et al.[2022]

The novel PSMA-targeted PET radiotracer [(18)F]DCFPyL detected 139 sites of metastatic prostate cancer in patients, significantly outperforming conventional imaging modalities (CIM), which only identified 45 lesions.

This study suggests that [(18)F]DCFPyL PET imaging is more effective in identifying metastatic disease, especially in cases where CIM results were negative or equivocal, highlighting its potential as a superior diagnostic tool for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PSMA-Based [(18)F]DCFPyL PET/CT Is Superior to Conventional Imaging for Lesion Detection in Patients with Metastatic Prostate Cancer. Rowe, SP., Macura, KJ., Mena, E., et al.[2022]

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 93 patients with biochemically recurrent prostate cancer, 18F-DCFPyL PET/CT scans identified disease in 82% of cases, significantly outperforming conventional imaging, which had an accuracy below 20%.

The use of 18F-DCFPyL PET/CT led to a change in management for 44% of patients, often shifting treatment from androgen deprivation therapy to targeted radiotherapy, highlighting its potential to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic performance of 18F-DCFPyL positron emission tomography/computed tomography for biochemically recurrent prostate cancer and change-of-management analysis. Chaussé, G., Ben-Ezra, N., Stoopler, M., et al.[2021]

In a study of 30 patients with intermediate to high-risk primary prostate cancer, 18F-DCFPyL-PET/CT demonstrated a high accuracy in localizing clinically significant prostate cancer (csPCa), with a detection rate of 93% for recommended biopsy segments.

The diagnostic performance of 18F-DCFPyL-PET/CT showed a sensitivity of 61.4% and specificity of 88.3% for identifying csPCa, indicating its potential as a valuable tool for guiding targeted prostate biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of prostate cancer with 18F-DCFPyL PET/CT compared to final histopathology of radical prostatectomy specimens: is PSMA-targeted biopsy feasible? The DeTeCT trial. Bodar, YJL., Jansen, BHE., van der Voorn, JP., et al.[2021]

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 ...

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

3.

pmc.ncbi.nlm.nih.gov

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

Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with ...

The ability of 18F-DCFPyL-PET/CT to localize and detect the extent of recurrent disease offers physicians the opportunity to adjust and tailor their treatment ...

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.

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.

pubs.rsna.org

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

18 F-DCFPyL PET/CT in Men with Prostate Cancer

F-DCFPyL PET may be helpful for primary staging in the setting of men with high-risk prostate cancer or in the work-up of men with prostate ...

8.

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 ...