Fluorine-18 - 2-(3-(1-carboxy-5-[(6-[18F]Fluoro-pyridine-3-carbonyl)-Amino]-Pentyl)-Ureido)-Pentanedioic Acid (18F-DCFPyL) Positron Emission Tomography / Computed Tomography (PET/CT) for Assessment of Recurrent Prostate Cancer
Sponsor study identifier
observational
2,244
1 country
1
Study Start
March 16, 2017
Actual (reported)Primary Completion
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Prostate cancer (PC) is the third most common cause of cancer death in men. Most patients with localized PC will be cured with surgery or radiation therapy, but up to 35% of patients will have their PC return. Whether it has returned locally or distantly determines which type of treatment they will receive. Current conventional imaging modalities have limitations particularly at low prostate-specific antigen (PSA) levels. This study proposes to use Fluorine-18-2-(3-(1-carboxy-5-\[(6-\[18F\]fluoro-pyridine-3-carbonyl)-amino\]-pentyl)-ureido)-pentanedioic acid (18F-DCFPyL) Positron Emission Tomography / Computer Tomography (PET/CT) scans which targets prostate-specific membrane antigens (PSMA) to detect where in the body the PC has recurred.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 9, 2016
Actual (reported)September 14, 2016
Actual (reported)March 16, 2017
Actual (reported)November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
superiority of 18F-DCFPyL PET/CT over conventional imaging for detection of recurrent prostate cancer.
Comparison to conventional imaging studies, pathology and clinical follow-up up to 3 years after PSMA imaging.
3 years after the PSMA PET scan
clinical impact of 18F-DCFPyL PET/CT
6 months after the PSMA PET scan
All participants will undergo the same procedures listed in "Detailed Description" in the protocol section.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The purpose of this study is to evaluate the diagnostic utility of 18F-DCFPyL PET/CT in identifying sites of prostate cancer recurrence where conventional imaging has been negative or equivocal. Concordance with histology, imaging or follow up will be assessed. This study will also assess the clinical impact of 18F-DCFPyL PET/CT on patient management.
BC Cancer
Vancouver, British Columbia, V5Z 4E6, Canada
Harsini S, Martineau P, Plaha S, Saprunoff H, Chen C, Bishop J, Tyldesley S, Wilson D, Benard F. Prognostic significance of a negative PSMA PET/CT in biochemical recurrence of prostate cancer. Cancer Imaging. 2024 Aug 30;24(1):117. doi: 10.1186/s40644-024-00752-1.
Harsini S, Wilson D, Saprunoff H, Allan H, Gleave M, Goldenberg L, Chi KN, Kim-Sing C, Tyldesley S, Benard F. Outcome of patients with biochemical recurrence of prostate cancer after PSMA PET/CT-directed radiotherapy or surgery without systemic therapy. Cancer Imaging. 2023 Mar 17;23(1):27. doi: 10.1186/s40644-023-00543-0.
Francois Benard, MD
BC Cancer
First Submitted
September 9, 2016
First Posted
September 14, 2016
Study Start
March 16, 2017
Actual (reported)Primary Completion
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Urology of Virginia Case Series
Contact the study team to confirm eligibility.
Study Completion
June 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
November 7, 2024
Record last verified: 2024-11
There is no plan to make individual participant data available?
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Source: ClinicalTrials.gov.
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