18F-DCFPyl PET Imaging for Prostate Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Dana-Farber Cancer Institute
Disqualifiers: Infections, Heart failure, Angina, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
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.
12345Is 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.
35678How 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.
34567Eligibility 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.
+5 more
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.
+1 more
Trial 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)
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Dana Farber Cancer InstituteBoston, MA
Brigham and Womens HospitalBoston, MA
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Who Is Running the Clinical Trial?
Dana-Farber Cancer InstituteLead Sponsor
Brigham and Women's HospitalLead Sponsor
Progenics Pharmaceuticals, Inc.Industry Sponsor
References
PSMA-Based [(18)F]DCFPyL PET/CT Is Superior to Conventional Imaging for Lesion Detection in Patients with Metastatic Prostate Cancer. [2022]Current standard of care conventional imaging modalities (CIM) such as X-ray computed tomography (CT) and bone scan can be limited for detection of metastatic prostate cancer and therefore improved imaging methods are an unmet clinical need. We evaluated the utility of a novel second-generation low molecular weight radiofluorinated prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) radiotracer, [(18)F]DCFPyL, in patients with metastatic prostate cancer.
Diagnostic performance of 18F-DCFPyL positron emission tomography/computed tomography for biochemically recurrent prostate cancer and change-of-management analysis. [2021]Label="INTRODUCTION" NlmCategory="BACKGROUND">Conventional imaging (CI) performs poorly to identify sites of disease in biochemically recurrent prostate cancer. 68Ga-PSMA-11 positron emission tomography/computed tomography (PET/CT) is most studied but has a very short half-life. This study reports the diagnostic performance of the novel prostate-specific membrane antigen (PSMA) radiotracer 18F-DCFPyL using real-life data and tumor board simulation to estimate the impact of 18F-DCFPyL PET on patient management.
Combined model-based and patient-specific dosimetry for 18F-DCFPyL, a PSMA-targeted PET agent. [2018]Label="PURPOSE">Prostate-specific membrane antigen (PSMA), a type-II integral membrane protein highly expressed in prostate cancer, has been extensively used as a target for imaging and therapy. Among the available PET radiotracers, the low molecular weight agents that bind to PSMA are proving particularly effective. We present the dosimetry results for 18F-DCFPyL in nine patients with metastatic prostate cancer.
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]Label="PURPOSE" NlmCategory="OBJECTIVE">In primary prostate cancer (PCa) patients, accurate staging and histologic grading are crucial to guide treatment decisions. 18F-DCFPyL (PSMA)-PET/CT has been successfully introduced for (re)staging PCa, showing high accuracy to localise PCa in lymph nodes and/or osseous structures. The diagnostic performance of 18F-DCFPyL-PET/CT in localizing primary PCa within the prostate gland was assessed, allowing for PSMA-guided targeted-prostate biopsy.
Role of 18F-DCFPyL PET/CT in patients with suspected prostate cancer. [2022]Label="OBJECTIVE" NlmCategory="OBJECTIVE">Fluorine-18-2-(3-{1-carboxy-5-[(6-18F-flfluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid (18F-DCFPyL), a novel positron emission tomography/computed tomography (PET/CT) radiotracer that binds to the prostate specific membrane antigen (PSMA), is increasingly used for biochemically recurrent prostate cancer diagnostics. However, the 18F-DCFPyL characteristics of suspected prostate cancer (SPCa) have been even more rarely described. Herein, in this retrospective study, we describe the clinical impact of 18F-DCFPyL PET/CT imaging in SPCa.
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 (2-(3-{1-carboxy-5-[(6-18F-fluoropyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid) is a promising PET radiopharmaceutical targeting prostate-specific membrane antigen (PSMA). We present our experience with this single-academic-center prospective study evaluating the positivity rate of 18F-DCFPyL PET/CT in patients with biochemical recurrence (BCR) of prostate cancer (PC). Methods: We prospectively enrolled 72 men (52-91 y old; mean ± SD, 71.5 ± 7.2) with BCR after primary definitive treatment with prostatectomy (n = 42) or radiotherapy (n = 30). The presence of lesions compatible with PC was evaluated by 2 independent readers. Fifty-nine patients had scans concurrent with at least one other conventional scan: bone scanning (24), CT (21), MR (20), 18F-fluciclovine PET/CT (18), or 18F-NaF PET (14). Findings from 18F-DCFPyL PET/CT were compared with those from other modalities. Impact on patient management based on 18F-DCFPyL PET/CT was recorded from clinical chart review. Results:18F-DCFPyL PET/CT had an overall positivity rate of 85%, which increased with higher prostate-specific antigen (PSA) levels (ng/mL): 50% (PSA < 0.5), 69% (0.5 ≤ PSA < 1), 100% (1 ≤ PSA < 2), 91% (2 ≤ PSA < 5), and 96% (PSA ≥ 5). 18F-DCFPyL PET detected more lesions than conventional imaging. For anatomic imaging, 20 of 41 (49%) CT or MRI scans had findings congruent with 18F-DCFPyL, whereas 18F-DCFPyL PET was positive in 17 of 41 (41%) cases with negative CT or MRI findings. For bone imaging, 26 of 38 (68%) bone or 18F-NaF PET scans were congruent with 18F-DCFPyL PET, whereas 18F-DCFPyL PET localized bone lesions in 8 of 38 (21%) patients with negative results on bone or 18F-NaF PET scans. In 8 of 18 (44%) patients, 18F-fluciclovine PET had located the same lesions as did 18F-DCFPyL PET, whereas 5 of 18 (28%) patients with negative 18F-fluciclovine findings had positive 18F-DCFPyL PET findings and 1 of 18 (6%) patients with negative 18F-DCFPyL findings had uptake in the prostate bed on 18F-fluciclovine PET. In the remaining 4 of 18 (22%) patients, 18F-DCFPyL and 18F-fluciclovine scans showed different lesions. Lastly, 43 of 72 (60%) patients had treatment changes after 18F-DCFPyL PET and, most noticeably, 17 of these patients (24% total) had lesion localization only on 18F-DCFPyL PET, despite negative results on conventional imaging. Conclusion:18F-DCFPyL PET/CT is a promising diagnostic tool in the work-up of biochemically recurrent PC, given the high positivity rate as compared with Food and Drug Administration-approved currently available imaging modalities and its impact on clinical management in 60% of patients.
[18F]DCFPyL PET/CT for Imaging of Prostate Cancer. [2022]Prostate-specific membrane antigen (PSMA)-directed positron emission tomography (PET) has gained increasing interest for imaging of men affected by prostate cancer (PC). In recent years, 68Ga-labeled PSMA compounds have been widely utilized, although there is a trend towards increased utilization of 18F-labeled agents. Among others, [18F]DCFPyL (piflufolastat F 18, PYLARIFY) has been tested in multiple major trials, such as OSPREY and CONDOR, which provided robust evidence on the clinical utility of this compound for staging, restaging, and change in management. Recent explorative prospective trials have also utilized [18F]DCFPyL PET/CT for response assessment, e.g., in patients under abiraterone or enzalutamide, rendering this 18F-labeled PSMA radiotracer as an attractive biomarker for image-guided strategies in men with PC. After recent approval by the U.S. Food and Drug Administration, one may expect more widespread use, not only in the U.S., but also in Europe in the long term. In the present review, we will provide an overview of the current clinical utility of [18F]DCFPyL in various clinical settings for men with PC.
Prospective intraindividual comparison of 18F-PSMA-7Q and 18F-DCFPyL PET/CT in patients with newly diagnosed prostate cancer. [2023]Fluorine 18 (18F)-2-(3-{1-Carboxy-5-[(6-[(18)F]fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid (DCFPyL) is an early 18F-labeled prostate-specific membrane antigen (PSMA) targeted PET tracer that has shown promise in the diagnostic workup of prostate cancer and was recently approved by the US Food and Drug Administration. 18F-PSMA-7Q is a novel 18F-labeled PSMA-ligand PET tracer designed and synthesized by our team. This study compared the tracer-specific positron emission tomography/computed tomography (PET/CT) characteristics of 18F-PSMA-7Q with those of 18F-DCFPyL in patients with newly diagnosed prostate cancer.