30 Participants Needed

18F-DCFPyl PET Imaging for Prostate Cancer

Recruiting at 1 trial location
HJ
Overseen ByHeather Jacene, MD
Age: 18+
Sex: Male
Trial Phase: Phase 4
Sponsor: Dana-Farber Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to see how well an imaging test, called 18FDCFPyL prostate specific membrane antigen (PSMA) positron emission tomography (PET), can show the extent of prostate cancer when comparing to 68Ga-PSMA-11 PET/CT (another type of diagnostic scan for prostate cancer).

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 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 more informed decisions about patient care by accurately locating cancer in the body.12345

Is 18F-DCFPyL PET imaging safe for humans?

18F-DCFPyL, used in PET imaging for prostate cancer, has been tested in multiple trials and is approved by the U.S. Food and Drug Administration, indicating it is generally considered safe for human use.35678

How does 18F-DCFPyL PET imaging differ from other prostate cancer treatments?

18F-DCFPyL PET imaging is unique because it uses a radiotracer that specifically targets the prostate-specific membrane antigen (PSMA), allowing for more accurate detection and localization of prostate cancer lesions compared to conventional imaging methods. This can lead to changes in patient management, as it often identifies cancer that other scans miss.34567

Research Team

Dr. Heather A Jacene, MD - Boston, MA ...

Heather Jacene

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.
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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.
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Timeline

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)

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: 18F-DCFPYL-PSMA PETExperimental Treatment1 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.

Find a Clinic Near You

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+

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.
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.
Diagnostic performance of 18F-DCFPyL positron emission tomography/computed tomography for biochemically recurrent prostate cancer and change-of-management analysis.Chaussรฉ, 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.
Combined model-based and patient-specific dosimetry for 18F-DCFPyL, a PSMA-targeted PET agent.Plyku, D., Mena, E., Rowe, SP., et al.[2018]

References

PSMA-Based [(18)F]DCFPyL PET/CT Is Superior to Conventional Imaging for Lesion Detection in Patients with Metastatic Prostate Cancer. [2022]
Diagnostic performance of 18F-DCFPyL positron emission tomography/computed tomography for biochemically recurrent prostate cancer and change-of-management analysis. [2021]
Combined model-based and patient-specific dosimetry for 18F-DCFPyL, a PSMA-targeted PET agent. [2018]
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]
Role of 18F-DCFPyL PET/CT in patients with suspected prostate cancer. [2022]
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]
[18F]DCFPyL PET/CT for Imaging of Prostate Cancer. [2022]
Prospective intraindividual comparison of 18F-PSMA-7Q and 18F-DCFPyL PET/CT in patients with newly diagnosed prostate cancer. [2023]