18F-DCFPyl PET Imaging for Prostate Cancer

Recruiting at 1 trial location

Overseen By Heather Jacene, MD

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Infections, Heart failure, Angina, 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: 7

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a new imaging test, 18F-DCFPyL PET, in detecting prostate cancer. It compares this test to the 68Ga-PSMA-11 PET/CT scan to determine which provides better information. The trial seeks men with confirmed prostate cancer who plan to receive specific cancer treatment afterward. Those who recently had a 68Ga-PSMA-11 PET scan and show signs of prostate cancer may find this trial suitable. Participants will undergo the new imaging test and receive follow-up for a year to monitor their response to standard treatment. As a Phase 4 trial, this study involves an FDA-approved imaging test, aiming to understand its benefits for more patients.

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 is the safety track record for 18F-DCFPyL?

Research has shown that the 18F-DCFPyL PET scan is safe for people. Studies have used this imaging test to effectively find prostate cancer. It is sensitive, accurately detecting cancer even when small, which aids doctors in making better treatment decisions.

Reports from these studies do not mention any serious safety issues. The test consistently performs well, demonstrating reliability. Overall, evidence suggests that 18F-DCFPyL is well-tolerated, making it a safe choice for imaging prostate cancer. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about 18F-DCFPyl PET imaging for prostate cancer because it offers a more precise method of detecting cancerous cells. Unlike traditional imaging techniques, which often rely on MRI or CT scans, 18F-DCFPyl PET uses a radiotracer that targets the prostate-specific membrane antigen (PSMA) on cancer cells, providing clearer and more detailed images. This precision can potentially lead to earlier detection and more accurate assessment of cancer spread, helping doctors tailor treatments more effectively for each patient.

What evidence suggests that this imaging technique is effective for detecting prostate cancer?

Research has shown that 18F-DCFPyL PET scans, which participants in this trial will undergo, effectively detect prostate cancer. Studies indicate that this imaging test can accurately determine the extent of cancer spread, aiding doctors in developing better treatment plans. The scan performs comparably to another type, 68Ga-PSMA-11 PET/CT, already approved by the FDA for staging prostate cancer. In one study, 18F-DCFPyL PET scans correctly identified cancer locations with an accuracy of 84.8% to 87.0%. This evidence suggests that 18F-DCFPyL PET is a reliable tool for assessing prostate cancer. ^{4 6 7 8 9}

Who Is on the Research Team?

Heather Jacene

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults with confirmed prostate cancer who are set to receive standard 177Lu-Vipivotide Tetraxetan therapy. They must have shown a positive response on a previous diagnostic scan and be willing to use birth control. People with severe illnesses, allergies to similar drugs, or conditions that could affect the study's outcome can't participate.

Inclusion Criteria

I have another cancer type, but it won't affect this trial's treatment.

I agree to use birth control or abstain from sex for 24 hours after the PSMA-PET scan.

You are capable and committed to participating in the study.

Exclusion Criteria

I do not have any uncontrolled illnesses like infections or heart problems.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-DCFPyL

Any past or current condition that, in the opinion of the study investigators, would confound the results of the study or would pose additional risk or burden to the patient by their participation in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Imaging

Baseline screening visit with PSMA-PET/CT scan with Ga-PSMA-11

1 day

1 visit (in-person)

Diagnostic Imaging

In-clinic visit with exam and PSMA-PET/CT scan with 18F-DCFPyl per standard institutional procedures

1 day

1 visit (in-person)

Standard of Care Therapy

Participants receive standard of care therapy

Follow-up

Follow up every 3 months via chart review for 12 months, with the purpose of seeing how participants respond to 177Lu-vipivotide tetraxetan treatment

12 months

4 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• 18F-DCFPyL

Trial Overview The study tests how well an imaging test called 18F-DCFPyL PSMA-PET can show the spread of prostate cancer compared to another scan type (68Ga-PSMA-11 PET/CT). Participants will undergo this new imaging procedure before their planned therapy.

How Is the Trial Designed?

Group I: 18F-DCFPYL-PSMA PET Experimental Treatment 1 Intervention

Study procedures will be conducted as follows: * Baseline screening visit with PSMA-PET/CT scan with Ga-PSMA-11. * In-clinic visit with exam and PSMA-PET/CT scan with 18F-DCFPyl per standard institutional procedures. * Standard of care therapy. * Follow up every 3 months via chart review for 12 months, with the purpose of seeing how participants respond to 177Luvipivotide tetraxetan treatment.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Progenics Pharmaceuticals, Inc.

Industry Sponsor

Trials

35

Recruited

4,400+

Published Research Related to This Trial

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 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]

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 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]

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 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 ... 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 ...

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/PMC10938285/

Diagnostic performance of 18F‑DCFPyL PET vs. 68Ga ... A comparable diagnostic performance for patients with suspected PCa was determined for 18 F-DCFPyL PET and 68 Ga-PSMA PET/CT.

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. urotoday.com urotoday.com/library-resources/imaging-center/157319-new-pet-imaging-tracers-for-the-primary-staging-of-unfavorable-intermediate-and-high-risk-prostate-cancer.html

New PET Imaging Tracers for the Primary Staging of ... In December 2020, Gallium 68 PSMA-11 (68Ga PSMA-11) was approved by the U.S. Food and Drug Administration (FDA) for the initial staging of prostate cancer ...

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/NCT03852654

18F-DCFPyL PET-CT Scan and Prostate Cancer The primary clinical endpoint of our study is the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT identifies M1 disease at initial ...

8. 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 ...

9. jnm.snmjournals.org jnm.snmjournals.org/content/61/6/881

18F-DCFPyL PET/CT Imaging in Patients with ... 18 F-DCFPyL PET/CT imaging offers high detection rates in biochemically recurrent prostate cancer patients and is positive in about 50% of patients with a PSA ...