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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the experimental radiotracer 18F-DCFPyL can identify the spread of prostate cancer in the body. Prostate cancer is a leading cause of cancer deaths in men, and the trial aims to improve imaging techniques for better detection. Participants will receive injections and undergo imaging scans, similar to advanced X-rays, to evaluate the effectiveness of these tracers. Men with prostate cancer that has spread beyond the prostate may be suitable for this study. Researchers will monitor participants for a year to gather more data about their cancer. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in cancer detection.

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 prior data suggests that this imaging technique is safe for prostate cancer patients?

Research has shown that 18F-DCFPyL is generally safe for people with prostate cancer. This substance aids in creating images of cancer in the body and is well-tolerated. For example, one study found it effective in locating prostate cancer without causing serious side effects. Another study confirmed its safety and reliability for detecting cancer recurrence.

Similarly, 18F-NaF is used in imaging and is a well-known agent for bone scans with a good safety record. Both imaging agents provide detailed pictures and support the diagnosis and management of prostate cancer. Participants can feel reassured that these agents have been carefully studied for safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 18F-DCFPyL for prostate cancer because it offers a novel approach to imaging that might improve diagnosis and monitoring. Unlike standard imaging techniques like MRI or CT scans, which can sometimes miss small or hidden tumors, 18F-DCFPyL is a PET imaging tracer that specifically targets prostate-specific membrane antigen (PSMA). This targeting allows for potentially more precise detection of prostate cancer cells. This precision in imaging could lead to better treatment decisions and outcomes for patients.

What evidence suggests that 18F-DCFPyL is effective for identifying prostate cancer?

Research has shown that 18F-DCFPyL, which participants in this trial may receive, effectively detects prostate cancer. It binds well to PSMA, a protein in prostate cancer cells, and accurately identifies cancer. One study found it detected cancer in 84.8% to 87.0% of cases, a notably high rate. This means 18F-DCFPyL can reliably locate prostate cancer in the body. It is more sensitive than other imaging methods, making it a promising tool for spotting cancer. ^{3 6 7 8 9}

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?

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

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

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

I have prostate cancer that has spread, confirmed by scans.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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 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]

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]

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]

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]

Citations

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

Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with ... F-DCFPyL is a small molecule that binds to the extracellular domain of PSMA with high affinity and has shown success in studies evaluating the detection of ...

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

Evaluation of 18F-DCFPyL PSMA PET/CT for Prostate ... Conclusion: 18F-DCFPyL PSMA PET/CT had good sensitivity and specificity for the diagnosis of prostate cancer. The DR of 18F-DCFPyL PSMA PET/CT ...

3. 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 > ...

4. 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 ...

5. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251575

Comparison of [¹⁸F]PSMA-1007, [¹⁸F]DCFPyL, and [⁶⁸Ga ... [¹⁸F]PSMA-1007 excels in low PSA settings but risks false positives, while [¹⁸F]DCFPyL offers high detection and flexibility. Tailored tracer ...

6. 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 ...

7. 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 ...

8. aacrjournals.org aacrjournals.org/clincancerres/article/27/13/3674/671523/Diagnostic-Performance-of-18F-DCFPyL-PET-CT-in-Men

Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with ... These data support 18F-DCFPyL-PET/CT as a safe and robust imaging tool to reliably detect recurrent prostate cancer, even at low PSA levels, thus providing new ...

9. 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 ...