18F-DCFPyL Imaging for Prostate Cancer

Overseen By Deborah E Citrin, M.D.

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must be taking: Androgen deprivation therapy

Disqualifiers: Prior prostate cancer treatment, 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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Varies based on treatment plan

130 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: Identifying medium- and high-risk prostate cancer early may allow for treatments to work. But identification can be hard. Researchers want to see if a radiotracer used during PET scans can help. Objective: To test how an imaging agent called 18F-DCFPyL detects response to standard prostate cancer treatment. Eligibility: People ages 18 and older with newly diagnosed prostate cancer who have no evidence of distant metastatic disease and plan to get stereotactic body radiation therapy (SBRT) with or without androgen deprivation therapy (ADT). Design: Participants will be screened with: Medical history Physical exam Blood tests MRI Participants will have baseline MRI and PET/CT scans. For the MRI, they may get a contrast agent by IV injection. For the PET/CT scan, they will get an IV injection of 18FDCFPyL. About 1 to 2 hours later, they will get the PET/CT scan. During the scans, participants will lie on their back and remain still for 45 minutes to 1 hour. These scans will be repeated at different points during the study. Participants will get SBRT with or without ADT. Participants will complete questionnaires about their quality of life. Participants will be asked about any symptoms they are having. They will also be asked about medications they are using. They may have a physical exam. Participants will give blood and urine samples. They will give a tumor sample from a biopsy they have had in the past. After treatment, participants will have follow-up visits. These will occur 1 month after treatment, then every 3 months for a year, and then every 6 months for 1 more year.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you will be asked about the medications you are using, so it's best to discuss this with the trial team.

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

Research shows that 18F-DCFPyL PET/CT is better at finding prostate cancer that has spread compared to traditional imaging methods. It helps doctors make better treatment decisions by accurately locating cancer in the body. ^{1 2 3 4 5}

Is 18F-DCFPyL safe for use in humans?

The studies on 18F-DCFPyL, a PET imaging agent for prostate cancer, do not report specific safety concerns, suggesting it is generally safe for human use. It has been used in multiple trials and is approved by the U.S. Food and Drug Administration, indicating a favorable safety profile. ^{3 5 6 7 8}

How does the drug 18F-DCFPyL differ from other prostate cancer treatments?

18F-DCFPyL is a unique imaging drug that targets the prostate-specific membrane antigen (PSMA) to help locate prostate cancer more accurately than conventional imaging methods. It has a high positivity rate, especially in patients with higher PSA levels, and can detect lesions that other scans might miss, leading to changes in patient management. ^{3 4 5 6 7}

Research Team

Deborah Citrin, MD

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

This trial is for men aged 18+ with newly diagnosed localized prostate cancer, planning to undergo SBRT possibly with ADT. They must have an ECOG status of <=2, use contraception if applicable, and can't have prior prostate cancer treatments. HIV-positive participants are eligible if virally suppressed.

Inclusion Criteria

My hepatitis C is cured or currently treated with no detectable virus.

I have prostate cancer confirmed by MRI and biopsy.

My hepatitis B virus load is undetectable with treatment.

Exclusion Criteria

My cancer has spread beyond the prostate.

I cannot undergo radiation or SBRT due to health reasons.

I have had hormone therapy, radiation, or surgery for prostate cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Imaging

Participants will have baseline MRI and PET/CT scans with 18F-DCFPyL

1 week

1 visit (in-person)

Treatment

Participants receive SBRT with or without ADT

Varies based on treatment plan

Multiple visits (in-person)

Post-Treatment Imaging

Participants undergo 18F-DCFPyL PET/CT and mpMRI 6 months following completion of SBRT

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits 1 month after treatment, then every 3 months for a year, and then every 6 months for 1 more year

2 years

Multiple visits (in-person)

Treatment Details

Interventions

• 18F-DCFPyL

Trial Overview Researchers are testing the effectiveness of a PET scan imaging agent called 18F-DCFPyL in detecting how well standard prostate cancer treatment works. Participants will undergo MRI and PET/CT scans before and after receiving SBRT (with or without ADT) to assess treatment response.

Participant Groups

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

18F-DCFPyL imaging with routine imaging (mpMRI)

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Findings from Research

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 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]

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 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]

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 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]

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]

In a study of 26 patients with high-risk localized prostate cancer, 18F-DCFPyL PET/CT demonstrated a high sensitivity of 90.9% for detecting tumors, which is comparable to the 86.4% sensitivity of multiparametric MRI (mpMRI).

The PET/CT imaging not only identified tumors that mpMRI missed but also showed significantly higher uptake in tumor tissue compared to nonmalignant tissue, indicating its potential for better disease characterization and correlation with cancer severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Evaluation of 18F-DCFPyL PET/CT in Detection of High-Risk Localized Prostate Cancer: Comparison With mpMRI. Gaur, S., Mena, E., Harmon, SA., et al.[2022]

References

1. United States 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. [2022]

2. Canada 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. [2021]

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

Combined model-based and patient-specific dosimetry for 18F-DCFPyL, a PSMA-targeted PET agent. [2018]

4. Germany 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. [2021]

5. Greece pubmed.ncbi.nlm.nih.gov

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

6. 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]

7. Germany pubmed.ncbi.nlm.nih.gov

[18F]DCFPyL PET/CT for Imaging of Prostate Cancer. [2022]

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

Prospective Evaluation of 18F-DCFPyL PET/CT in Detection of High-Risk Localized Prostate Cancer: Comparison With mpMRI. [2022]