Evidence map›Paper›PMID 35852431›Full record

Trial reportRadiology2022

Gary A Ulaner, Beth Thomsen, Jeffrey Bassett, Robert Torrey, Craig Cox, Kevin Lin, Trushar Patel, Tust Techasith, Audrey Mauguen, Steven P Rowe and 4 more

2 registry-linked trialsOpen access · greenAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Radiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
4.1field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04700332 phase2recruitingnot on this map

2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-Amino]-Pentyl}-Ureido)-Pentanedioic Acid (PyL) in Patients With High Risk and Biochemically Recurrent Prostate Cancer

TypeinterventionalSponsorHoag Memorial Hospital PresbyterianRan2021 to 2022Enrolled184ConditionsProstate CancerArmsDCFPyL PET/CT
NCT07635524 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

A Two Center Phase 2 Trial of 61Cu-noDAGa-PSMA I&T (61Cu-NU101) for Patients With Prostate Cancer

TypeinterventionalSponsorHoag Memorial Hospital PresbyterianRan2026 to 2028Enrolled34ConditionsProstate CancerArmsCu-NU101
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

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  14. First-in-human study of PSMA-targeting agent, [European journal of nuclear medicine and molecular imaging · 2024
    Article
4 · The record

Corrections and comments

  • Commented on by
    2022
5 · Who and what money

Authors and funding

14 authors at 1 institution in 1 country.

Gary A UlanerFrom the Departments of Molecular Imaging and Therapy (G.A.U., B.T.), Urology (J.B., R.T., J.Y.), Radiation Oncology (C.C., K.L.), and Radiology (T.P., T.T.), Hoag Family Cancer Institute, 16105 Sand Canyon Ave, Irvine, CA 92618; Departments of Radiology and Translational Genomics, University of Southern California, Los Angeles, Calif (G.A.U.); Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY (A.M.); The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Md (S.P.R.); and Molecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, Md (L.L., E.M., P.C.).ORCID 0000-0002-7953-0113
Beth ThomsenFrom the Departments of Molecular Imaging and Therapy (G.A.U., B.T.), Urology (J.B., R.T., J.Y.), Radiation Oncology (C.C., K.L.), and Radiology (T.P., T.T.), Hoag Family Cancer Institute, 16105 Sand Canyon Ave, Irvine, CA 92618; Departments of Radiology and Translational Genomics, University of Southern California, Los Angeles, Calif (G.A.U.); Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY (A.M.); The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Md (S.P.R.); and Molecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, Md (L.L., E.M., P.C.).ORCID 0000-0001-5061-9504
Jeffrey BassettFrom the Departments of Molecular Imaging and Therapy (G.A.U., B.T.), Urology (J.B., R.T., J.Y.), Radiation Oncology (C.C., K.L.), and Radiology (T.P., T.T.), Hoag Family Cancer Institute, 16105 Sand Canyon Ave, Irvine, CA 92618; Departments of Radiology and Translational Genomics, University of Southern California, Los Angeles, Calif (G.A.U.); Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY (A.M.); The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Md (S.P.R.); and Molecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, Md (L.L., E.M., P.C.).
Robert TorreyFrom the Departments of Molecular Imaging and Therapy (G.A.U., B.T.), Urology (J.B., R.T., J.Y.), Radiation Oncology (C.C., K.L.), and Radiology (T.P., T.T.), Hoag Family Cancer Institute, 16105 Sand Canyon Ave, Irvine, CA 92618; Departments of Radiology and Translational Genomics, University of Southern California, Los Angeles, Calif (G.A.U.); Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY (A.M.); The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Md (S.P.R.); and Molecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, Md (L.L., E.M., P.C.).
Craig CoxFrom the Departments of Molecular Imaging and Therapy (G.A.U., B.T.), Urology (J.B., R.T., J.Y.), Radiation Oncology (C.C., K.L.), and Radiology (T.P., T.T.), Hoag Family Cancer Institute, 16105 Sand Canyon Ave, Irvine, CA 92618; Departments of Radiology and Translational Genomics, University of Southern California, Los Angeles, Calif (G.A.U.); Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY (A.M.); The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Md (S.P.R.); and Molecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, Md (L.L., E.M., P.C.).
Kevin LinFrom the Departments of Molecular Imaging and Therapy (G.A.U., B.T.), Urology (J.B., R.T., J.Y.), Radiation Oncology (C.C., K.L.), and Radiology (T.P., T.T.), Hoag Family Cancer Institute, 16105 Sand Canyon Ave, Irvine, CA 92618; Departments of Radiology and Translational Genomics, University of Southern California, Los Angeles, Calif (G.A.U.); Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY (A.M.); The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Md (S.P.R.); and Molecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, Md (L.L., E.M., P.C.).ORCID 0000-0003-0344-4304
Trushar PatelFrom the Departments of Molecular Imaging and Therapy (G.A.U., B.T.), Urology (J.B., R.T., J.Y.), Radiation Oncology (C.C., K.L.), and Radiology (T.P., T.T.), Hoag Family Cancer Institute, 16105 Sand Canyon Ave, Irvine, CA 92618; Departments of Radiology and Translational Genomics, University of Southern California, Los Angeles, Calif (G.A.U.); Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY (A.M.); The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Md (S.P.R.); and Molecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, Md (L.L., E.M., P.C.).ORCID 0000-0002-9598-6479
Tust TechasithFrom the Departments of Molecular Imaging and Therapy (G.A.U., B.T.), Urology (J.B., R.T., J.Y.), Radiation Oncology (C.C., K.L.), and Radiology (T.P., T.T.), Hoag Family Cancer Institute, 16105 Sand Canyon Ave, Irvine, CA 92618; Departments of Radiology and Translational Genomics, University of Southern California, Los Angeles, Calif (G.A.U.); Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY (A.M.); The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Md (S.P.R.); and Molecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, Md (L.L., E.M., P.C.).ORCID 0000-0001-8063-6161
Audrey MauguenFrom the Departments of Molecular Imaging and Therapy (G.A.U., B.T.), Urology (J.B., R.T., J.Y.), Radiation Oncology (C.C., K.L.), and Radiology (T.P., T.T.), Hoag Family Cancer Institute, 16105 Sand Canyon Ave, Irvine, CA 92618; Departments of Radiology and Translational Genomics, University of Southern California, Los Angeles, Calif (G.A.U.); Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY (A.M.); The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Md (S.P.R.); and Molecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, Md (L.L., E.M., P.C.).ORCID 0000-0003-3236-6093
Steven P RoweFrom the Departments of Molecular Imaging and Therapy (G.A.U., B.T.), Urology (J.B., R.T., J.Y.), Radiation Oncology (C.C., K.L.), and Radiology (T.P., T.T.), Hoag Family Cancer Institute, 16105 Sand Canyon Ave, Irvine, CA 92618; Departments of Radiology and Translational Genomics, University of Southern California, Los Angeles, Calif (G.A.U.); Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY (A.M.); The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Md (S.P.R.); and Molecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, Md (L.L., E.M., P.C.).ORCID 0000-0003-2897-4694
Liza LindenbergFrom the Departments of Molecular Imaging and Therapy (G.A.U., B.T.), Urology (J.B., R.T., J.Y.), Radiation Oncology (C.C., K.L.), and Radiology (T.P., T.T.), Hoag Family Cancer Institute, 16105 Sand Canyon Ave, Irvine, CA 92618; Departments of Radiology and Translational Genomics, University of Southern California, Los Angeles, Calif (G.A.U.); Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY (A.M.); The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Md (S.P.R.); and Molecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, Md (L.L., E.M., P.C.).ORCID 0000-0002-8514-0648
Esther MenaFrom the Departments of Molecular Imaging and Therapy (G.A.U., B.T.), Urology (J.B., R.T., J.Y.), Radiation Oncology (C.C., K.L.), and Radiology (T.P., T.T.), Hoag Family Cancer Institute, 16105 Sand Canyon Ave, Irvine, CA 92618; Departments of Radiology and Translational Genomics, University of Southern California, Los Angeles, Calif (G.A.U.); Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY (A.M.); The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Md (S.P.R.); and Molecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, Md (L.L., E.M., P.C.).
Peter ChoykeFrom the Departments of Molecular Imaging and Therapy (G.A.U., B.T.), Urology (J.B., R.T., J.Y.), Radiation Oncology (C.C., K.L.), and Radiology (T.P., T.T.), Hoag Family Cancer Institute, 16105 Sand Canyon Ave, Irvine, CA 92618; Departments of Radiology and Translational Genomics, University of Southern California, Los Angeles, Calif (G.A.U.); Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY (A.M.); The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Md (S.P.R.); and Molecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, Md (L.L., E.M., P.C.).ORCID 0000-0003-1086-8826
Jeffrey YoshidaFrom the Departments of Molecular Imaging and Therapy (G.A.U., B.T.), Urology (J.B., R.T., J.Y.), Radiation Oncology (C.C., K.L.), and Radiology (T.P., T.T.), Hoag Family Cancer Institute, 16105 Sand Canyon Ave, Irvine, CA 92618; Departments of Radiology and Translational Genomics, University of Southern California, Los Angeles, Calif (G.A.U.); Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY (A.M.); The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Md (S.P.R.); and Molecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, Md (L.L., E.M., P.C.).
University of Southern California · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

Background Prostate-specific membrane antigen (PSMA) PET is standard for newly diagnosed high-risk and biochemically recurrent (BCR) prostate cancer. Although studies suggest high specificity of 2-(3-{1-carboxy-5-[(6-[(18)F]fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid (DCFPyL) for targeting PSMA, false-positive findings have been identified and most studies lack histologic confirmation of malignancy. Purpose To estimate the positive predictive value (PPV) of DCFPyL PET/CT by providing histopathologic proof for DCFPyL-avid lesions suspected of being distant metastases at initial diagnosis and recurrence in BCR prostate cancer. Materials and Methods In this prospective trial, men with newly diagnosed high-risk prostate cancer (sample 1) or BCR prostate cancer and negative findings at conventional CT and/or bone scanning (sample 2) were enrolled between January and December 2021. All men underwent DCFPyL PET/CT. Suspected distant metastases and/or recurrences were biopsied. PPV was calculated. Results A total of 92 men with newly diagnosed prostate cancer (median age, 70 years; IQR, 64-75 years) (sample 1) and 92 men with BCR prostate cancer (median age, 71 years; IQR, 66-75 years) (sample 2) were enrolled. In sample 1, 25 of the 92 men (27%) demonstrated DCFPyL-avid lesions suspicious for distant metastases. Biopsy was performed in 23 of the 25 men (92%), with 17 of the 23 (74%) biopsies positive for malignancy and six (26%) benign. Of the six benign biopsies, three were solitary rib foci and three were solitary pelvic bone foci. In sample 2, 57 of the 92 men (62%) demonstrated DCFPyL-avid lesions suspicious for recurrence. Biopsy was performed in 37 of the 57 men (65%), with 33 of the 37 (89%) biopsies positive for malignancy and four (11%) benign. Of the four benign biopsies, two were subcentimeter pelvic nodes and/or nodules, one was a rib, and one was a pelvic bone focus. Conclusion PET/CT with 2-(3-{1-carboxy-5-[(6-[(18)F]fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid (DCFPyL) had a high biopsy-proven positive predictive value for distant metastases in newly diagnosed prostate cancer (74%) and for recurrence sites in men with biochemical recurrence (89%). However, there were DCFPyL-avid false-positive findings (particularly in ribs and pelvic bones). Solitary DCFPyL avidity in these locations should not be presumed as malignant. Biopsy may still be needed prior to therapy decisions. ClinicalTrials.gov registration no. NCT04700332 © RSNA, 2022 See also the editorial by Zukotynski and Kuo in this issue.

Indexed as

Positron Emission Tomography Computed TomographyProstatic NeoplasmsAgedHumansLysineMaleMiddle AgedProspective StudiesPyridinesTomography, X-Ray ComputedUreaLysinePyridinesUrea

Identifiers

PMID35852431
PMCPMC9619197
OpenAlexW4286223135

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.