PSMA-PET Scan for Prostate Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Disqualifiers: No follow up, Claustrophobia, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)" that had high risk Decipher test results (Decipher score \>0.45). Patients with a high genomic classifier (GC) score at diagnosis will be approached for formal consenting for PSMA-PET imaging at 2 years post treatment.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that you should not have had any radioisotope treatments recently, so it's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug F-DCFPyL Injection, Pylarify, 18F-DCFPyL for prostate cancer?
Research shows that the drug 18F-DCFPyL is effective in detecting prostate cancer lesions better than traditional imaging methods like CT scans and bone scans. It has been tested in major trials, such as OSPREY and CONDOR, which demonstrated its usefulness in staging and managing prostate cancer.
12345Is the PSMA-PET Scan using 18F-DCFPyL safe for humans?
The PSMA-PET Scan using 18F-DCFPyL, also known as Pylarify, has been tested in multiple major trials and is approved by the U.S. Food and Drug Administration for use in prostate cancer imaging. While the studies focus on its effectiveness, the approval suggests it has been deemed safe for human use in the context of these trials.
24678How does the PSMA-PET scan treatment for prostate cancer differ from other treatments?
The PSMA-PET scan using [18F]DCFPyL is unique because it targets a specific protein found in high amounts on prostate cancer cells, allowing for more precise imaging compared to traditional methods like CT or bone scans. This can help in better detecting and managing prostate cancer, especially in cases where the cancer has spread.
125910Eligibility Criteria
Men over 18 with high-risk prostate cancer, as indicated by a Decipher test score greater than 0.45, who were part of a previous study (MCC#18523) and have had either surgery or radiation therapy for their cancer. They must be in good physical condition (ECOG status 0-1) and have at least two years of follow-up data post-treatment.Inclusion Criteria
My biopsy or surgical sample has undergone genomic testing.
I am older than 18 years.
My Decipher score is above 0.45, indicating high risk.
+3 more
Exclusion Criteria
No follow up information available post treatment
Unable to undergo PET imaging due to pre-existing comorbidities and/or claustrophobia
I haven't had certain types of scans or contrasts recently.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Imaging
Participants receive F-DCFPyL PSMA PET imaging to detect recurrent/metastatic prostate cancer
Annually for 4 years
1 visit per year (in-person)
Follow-up
Participants are monitored for safety and effectiveness after imaging
5 years
Participant Groups
The trial is testing PSMA-PET imaging using F-DCFPyL injection to detect early metastatic prostate cancer in men with high genomic classifier scores from an earlier study. The goal is to see how well this imaging technique works for those at higher risk.
1Treatment groups
Experimental Treatment
Group I: Radioactive Diagnostic ImagingExperimental Treatment2 Interventions
Participants will receive F-DCFPyL PSMA PET imaging annually for 4 years. An administered dose of 9 ± 1 mCi (333 ±37 MBq) F-DCFPyL Injection will be administered via an in-dwelling catheter placed in an antecubital vein or an equivalent venous access.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
H. Lee Moffitt Cancer Center and Research InstituteTampa, FL
Loading ...
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
Progenics Pharmaceuticals, Inc.Industry Sponsor
References
A Pilot Study of Dynamic 18F-DCFPyL PET/CT Imaging of Prostate Adenocarcinoma in High-Risk Primary Prostate Cancer Patients. [2023]Label="PURPOSE">The primary aim of this study was to investigate the pharmacokinetics of 18F-DCFPyL, an 18F-labeled PSMA-based ligand, and to explore the utility of early time point positron emission tomography (PET) imaging extracted from PET data to distinguish malignant primary prostate from benign prostate tissue.
[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.
Automated synthesis of [(18)F]DCFPyL via direct radiofluorination and validation in preclinical prostate cancer models. [2020]Prostate-specific membrane antigen (PSMA) is frequently overexpressed and upregulated in prostate cancer. To date, various (18)F- and (68)Ga-labeled urea-based radiotracers for PET imaging of PSMA have been developed and entered clinical trials. Here, we describe an automated synthesis of [(18)F]DCFPyL via direct radiofluorination and validation in preclinical models of prostate cancer.
Image acquisition and interpretation of 18F-DCFPyL (piflufolastat F 18) PET/CT: How we do it. [2023]Prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) is rapidly becoming widely accepted as the standard-of-care for imaging of men with prostate cancer. Labeled indications for regulatoryapproved agents include primary staging and recurrent disease in men at risk of metastases. The first commercial PSMA PET agent to become available was 18F-DCFPyL (piflufolastat F 18), a radiofluorinated small molecule with high-affinity for PSMA. The regulatory approval of 18F-DCFPyL hinged upon two key, multi-center, registration trials, OSPREY (patient population: highrisk primary staging) and CONDOR (patient population: biochemical recurrence). In this manuscript, we will (1) review key findings from the OSPREY and CONDOR trials, (2) discuss the clinical acquisition protocol we use for 18F-DCFPyL PET scanning, (3) present information on important pearls and pitfalls, (4) provide an overview of the PSMA reporting and data system (PSMA-RADS) interpretive framework, and (5) posit important future directions for research in PSMA PET. Our overall goal is to provide a brief introduction for practices and academic groups that are adopting 18F-DCFPyL PET scans for use in their patients with prostate cancer.
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.
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.
Piflufolastat F 18: Diagnostic First Approval. [2022]Piflufolastat F 18 (PYLARIFY®) is an 18F-labelled diagnostic imaging agent that has been developed by Progenics Pharmaceuticals Inc., a Lantheus company, for positron emission tomography (PET) that targets prostate-specific membrane antigen (PSMA). Piflufolastat F 18 was approved in the USA on 27 May 2021 for PET of PSMA positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate specific antigen (PSA) level. This article summarizes the milestones in the development of piflufolastat F 18 leading to this approval as a radioactive diagnostic agent in prostate cancer.
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 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.
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.