PET Imaging Tracers 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 over 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

96 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: Prostate cancer is the second leading cause of cancer deaths in American men. Few options exist to create images of this type of cancer. Researchers think an experimental radiotracer called 18F-DCFPyL could find sites of cancer in the body. Objective: To see if 18F-DCFPyL can identify sites of prostate cancer in people with the disease. Eligibility: People ages 18 and older who have metastatic prostate cancer Design: Participants will be screened with: * Blood tests * Physical exam * Medical history Participants will be assigned to 1 of 2 groups based on their PSA. Participants will have 18F-DCFPyL injected into a vein. About 2 hours later they will have a whole-body Positron Emission Tomography/Computed Tomography (PET/CT). For the scan, they will lie on their back on the scanner table while it takes pictures of the body. This lasts about 50 minutes. On another day, participants will have 18F -NaF injected into a vein. About 1 hour later, they will have a whole-body PET/CT. Participants will be contacted 1 3 days later for follow-up. They may undergo PET/Magnetic Resonance Imaging (MRI) either after having a 18F-DCFPyL PET/CT, or in place of PET/CT imaging. A tube may be placed in the rectum. More coils may be wrapped around the outside of the pelvis. If the 18F-DCFPyL PET/CT is positive participants will be encouraged to undergo a biopsy of one of the tumors. The biopsy will be taken through a needle put through the skin into the tumor. Participants will be followed for 1 year. During this time researchers will collect information about their prostate cancer, such as PSA levels and biopsy results. About 4-6 months after scanning is completed, participants may have a tumor biopsy. The biopsy will be taken through a needle put through the skin into the tumor. ...

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

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

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

Research shows that 18F-DCFPyL PET/CT is better at detecting prostate cancer lesions compared to traditional imaging methods, which helps in managing the disease more effectively. It is also noted for its high accuracy in identifying cancer recurrence, which can significantly impact treatment decisions. ^{1 2 3 4 5}

Is 18F-DCFPyL safe for use in humans?

The research does not provide specific safety data for 18F-DCFPyL, but it has been used in multiple trials and approved by the U.S. Food and Drug Administration, suggesting it is considered safe for clinical use in imaging prostate cancer. ^{1 6 7 8 9}

How is the drug 18F-DCFPyL different from other prostate cancer treatments?

18F-DCFPyL is a novel imaging drug that targets the prostate-specific membrane antigen (PSMA) in prostate cancer, offering superior detection of cancerous lesions compared to conventional imaging methods. It is a second-generation PET radiotracer with a longer half-life than other PSMA-targeted tracers, allowing for more effective imaging and potentially improved patient management. ^{1 2 3 6 10}

Research Team

Peter L Choyke, M.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

This trial is for adults over 18 with metastatic prostate cancer, who can undergo a biopsy and have an ECOG score of 0-2. They must be enrolled in certain other protocols, understand the consent form, and not exceed weight limits for imaging equipment. Those with severe claustrophobia or conditions that conflict with study procedures are excluded.

Inclusion Criteria

I am 18 years old or older.

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

Ability of subject to understand and the willingness to sign a written informed consent document

Exclusion Criteria

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

Subjects weighing greater than 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry

Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Imaging and Biopsy

Participants undergo DCFPyL PET/CT (or PET/MRI), NaF-PET/CT, and FDG PET/CT imaging, followed by a mandatory research biopsy if feasible

3 weeks

Multiple visits (in-person)

Follow-up

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

4 years

Yearly follow-up (remote or in-person)

Treatment Details

Interventions

• 18F-DCFPyL
• 18F-NaF

Trial Overview The trial tests if a new radiotracer called 18F-DCFPyL can better detect prostate cancer compared to standard tracers (18F-NaF). Participants will receive injections of these tracers before undergoing PET/CT scans to see which provides clearer images of cancer sites.

Participant Groups

Group I: 1/Experimental intervention Experimental Treatment 3 Interventions

18F-DCFPyL is administered to cohorts

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 demonstrated that the 18F-DCFPyL PET imaging can effectively distinguish malignant prostate cancer from benign tissue, with significant differences in uptake values observed as early as 5 minutes post-injection in 10 patients with high-risk prostate cancer.

The pharmacokinetic analysis revealed that malignant prostate tissue had a 15-fold higher influx value (Ki) compared to benign prostatic hyperplasia and normal prostate tissue, indicating that 18F-DCFPyL PET imaging can be a valuable tool for early detection of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of Dynamic 18F-DCFPyL PET/CT Imaging of Prostate Adenocarcinoma in High-Risk Primary Prostate Cancer Patients. Lu, M., Lindenberg, L., Mena, E., et al.[2023]

18F-DCFPyL (piflufolastat F 18) is the first PSMA-targeted PET agent approved for imaging prostate cancer, demonstrating high affinity for PSMA and becoming the standard-of-care for primary staging and recurrent disease.

The approval of 18F-DCFPyL was based on two significant multi-center trials, OSPREY and CONDOR, which focused on high-risk primary staging and biochemical recurrence, respectively, highlighting its efficacy in identifying prostate cancer metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image acquisition and interpretation of 18F-DCFPyL (piflufolastat F 18) PET/CT: How we do it. Rowe, SP., Voter, AF., Werner, RA., 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]

The synthesized imaging agent [(18)F]DCFPyL effectively targets the prostate-specific membrane antigen (PSMA), showing a strong binding affinity (K(i) value of 1.1 nmol/L) and high uptake in PSMA-positive prostate tumors in mouse models.

[(18)F]DCFPyL demonstrated significant tumor delineation in PET imaging, with a remarkable uptake ratio of 358:1 between PSMA-positive and PSMA-negative tumors, indicating its potential as a specific imaging tool for prostate cancer with minimal uptake in non-target tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

2-(3-{1-Carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid, [18F]DCFPyL, a PSMA-based PET imaging agent for prostate cancer. Chen, Y., Pullambhatla, M., Foss, CA., et al.[2021]

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 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 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]

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

A Pilot Study of Dynamic 18F-DCFPyL PET/CT Imaging of Prostate Adenocarcinoma in High-Risk Primary Prostate Cancer Patients. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Threshold for defining PSMA-positivity prior to 177Lu-PSMA therapy: a comparison of [68Ga]Ga-PSMA-11 and [18F]F-DCFPyL in metastatic prostate cancer. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

Image acquisition and interpretation of 18F-DCFPyL (piflufolastat F 18) PET/CT: How we do it. [2023]

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

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

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

2-(3-{1-Carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid, [18F]DCFPyL, a PSMA-based PET imaging agent for prostate cancer. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

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

9. 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]

10. England pubmed.ncbi.nlm.nih.gov

Prospective intraindividual comparison of 18F-PSMA-7Q and 18F-DCFPyL PET/CT in patients with newly diagnosed prostate cancer. [2023]