Evidence map›Paper›PMID 30920593›Full record

Trial reportJAMA oncology2019

Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer: A Prospective Single-Arm Clinical Trial.

Wolfgang P Fendler, Jeremie Calais, Matthias Eiber, Robert R Flavell, Ashley Mishoe, Felix Y Feng, Hao G Nguyen, Robert E Reiter, Matthew B Rettig, Shozo Okamoto and 15 more

5 registry-linked trialsAbstract readClinical TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in JAMA oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 406 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
406citing papers in PubMed, 13 pooled it
–field-weighted citation impact
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.

NCT02940262 phase3completednot on this map

68Ga-PSMA PET/CT for Detection of Recurrent Prostate Cancer After Initial Therapy

TypeinterventionalSponsorJonsson Comprehensive Cancer CenterRan2016 to 2021Enrolled1,138ConditionsProstate Adenocarcinoma, Recurrent Prostate CarcinomaArmsGallium Ga 68 Gozetotide, Laboratory Biomarker Analysis, Positron Emission Tomography
NCT03353740 phase3completednot on this map

Gallium-68 PSMA-11 PET Imaging in Patients With Biochemical Recurrence

TypeinterventionalSponsorThomas HopeRan2017 to 2020Enrolled346ConditionsProstate CancerArmsGa-68 labeled PSMA-11 PET
NCT04854369 no longer availablenot on this map

68Ga-PSMA-11 Patients With Newly Diagnosed and Recurrent Prostate Cancer

Typeexpanded_accessSponsorTulane UniversityConditionsProstatic Neoplasms, Prostatic Neoplasms, Castration-ResistantArms68 Ga-PSMA-11 prepared using a PSMA-11 Sterile Cold Kit
NCT05936658 phase3active not recruitingnot on this mapstarted 2023, after this paper: background citation

A Multi-center, Open-label, Single Arm Phase III Clinical Trial for the Diagnostic Efficacy Assessment and Safety Evaluation by [18F]Florastamin PET/CT Imaging Examination in Patients With Suspected Recurrent or Metastatic Prostate Cancer

TypeinterventionalSponsorFutureChemRan2023 to 2025Enrolled138ConditionsHigh Risk Prostate CarcinomaArms[F-18]Florastamin
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

406 citing papers in PubMed, 13 syntheses or guidelines pooled it.

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  10. Meta-analysis ofCancer imaging : the official publication of the International Cancer Imaging Society · 2023
    Pooled it
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  13. Guideline
  14. Radiographic Progression With and Without Prostate-Specific Antigen Rise in Patients With Advanced Prostate Cancer Treated With Enzalutamide.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026
    Trial
  15. An intra-patient contemporaneous comparison ofEuropean journal of nuclear medicine and molecular imaging · 2026
    Trial
  16. LASER: A Phase 2 Trial ofJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026
    Trial
  17. The German Cancer Consortium (DKTK) multi-center prospective phase 1/2European journal of nuclear medicine and molecular imaging · 2026
    Trial
  18. Imaging Efficacy of [Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2025
    Trial
  19. Diuresis DuringJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2025
    Trial
  20. True-PositiveJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2024
    Trial

346 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors.

Wolfgang P FendlerAhmanson Translational Imaging Division, Department of Molecular and Medical Pharmacology, University of California Los Angeles, Los Angeles.
Jeremie CalaisAhmanson Translational Imaging Division, Department of Molecular and Medical Pharmacology, University of California Los Angeles, Los Angeles.
Matthias EiberAhmanson Translational Imaging Division, Department of Molecular and Medical Pharmacology, University of California Los Angeles, Los Angeles.
Robert R FlavellDepartments of Radiology and Biomedical Imaging and Pharmaceutical Chemistry, University of California San Francisco, San Francisco.
Ashley MishoeDepartments of Radiology and Biomedical Imaging and Pharmaceutical Chemistry, University of California San Francisco, San Francisco.
Felix Y FengDepartment of Urology, University of California San Francisco, San Francisco.
Hao G NguyenHelen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco.
Robert E ReiterDepartment of Urology, UCLA Medical Center, University of California Los Angeles, Los Angeles.
Matthew B RettigDepartment of Urology, UCLA Medical Center, University of California Los Angeles, Los Angeles.
Shozo OkamotoDepartment of Radiology, Obihiro Kosei Hospital, Obihiro, Japan.
Louise EmmettDepartment of Theranostics and Nuclear Medicine, St Vincent's Hospital, Sydney, Australia.
Helle D ZachoDepartment of Nuclear Medicine, Aalborg University Hospital, Aalborg, Denmark.
Harun IlhanDepartment of Nuclear Medicine, Ludwig-Maximilians-University Munich, Munich, Germany.
Axel WetterDepartment of Diagnostic and Interventional Radiology and Neuroradiology, University of Duisburg-Essen, Essen, Germany.
Christoph RischplerDepartment of Nuclear Medicine, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
Heiko SchoderMolecular Imaging and Therapy Service, Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York.
Irene A BurgerDepartment of Nuclear Medicine, University Hospital Zürich, University of Zürich, Switzerland.
Jeannine GartmannAhmanson Translational Imaging Division, Department of Molecular and Medical Pharmacology, University of California Los Angeles, Los Angeles.
Raven SmithDepartments of Radiology and Biomedical Imaging and Pharmaceutical Chemistry, University of California San Francisco, San Francisco.
Eric J SmallHelen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco.
Roger SlavikAhmanson Translational Imaging Division, Department of Molecular and Medical Pharmacology, University of California Los Angeles, Los Angeles.
Peter R CarrollDepartment of Urology, University of California San Francisco, San Francisco.
Ken HerrmannAhmanson Translational Imaging Division, Department of Molecular and Medical Pharmacology, University of California Los Angeles, Los Angeles.
Johannes CzerninAhmanson Translational Imaging Division, Department of Molecular and Medical Pharmacology, University of California Los Angeles, Los Angeles.
Thomas A HopeDepartments of Radiology and Biomedical Imaging and Pharmaceutical Chemistry, University of California San Francisco, San Francisco.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
UCLA SPORE in Brain CancerP50CA211015 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Yvonne Yu-Hsuan Chen · 2017 to 2026
$25.2M
NCI NIH HHS P30 CA008748NCI NIH HHS P50 CA211015
6 · The paper itself

Abstract

importanceIn retrospective studies, 68Ga-PSMA-11 positron emission tomographic (PET) imaging improves detection of biochemically recurrent prostate cancer compared with conventional imaging.

objectiveTo assess 68Ga-PSMA-11 PET accuracy in a prospective multicenter trial. DESIGN, SETTING, AND

participantsIn this single-arm prospective trial conducted at University of California, San Francisco and University of California, Los Angeles, 635 patients with biochemically recurrent prostate cancer after prostatectomy (n = 262, 41%), radiation therapy (n = 169, 27%), or both (n = 204, 32%) underwent 68Ga-PSMA-11 PET. Presence of prostate cancer was recorded by 3 blinded readers on a per-patient and per-region base. Lesions were validated by histopathologic analysis and a composite reference standard. MAIN OUTCOMES AND MEASURES: Endpoints were positive predictive value (PPV), detection rate, interreader reproducibility, and safety.

resultsA total of 635 men were enrolled with a median age of 69 years (range, 44-95 years). On a per-patient basis, PPV was 0.84 (95% CI, 0.75-0.90) by histopathologic validation (primary endpoint, n = 87) and 0.92 (95% CI, 0.88-0.95) by the composite reference standard (n = 217). 68Ga-PSMA-11 PET localized recurrent prostate cancer in 475 of 635 (75%) patients; detection rates significantly increased with prostate-specific antigen (PSA): 38% for <0.5 ng/mL (n = 136), 57% for 0.5 to <1.0 ng/mL (n = 79), 84% for 1.0 to <2.0 ng/mL (n = 89), 86% for 2.0 to <5.0 ng/mL (n = 158), and 97% for ≥5.0 ng/mL (n = 173, P < .001). Interreader reproducibility was substantial (Fleiss κ, 0.65-0.78). There were no serious adverse events associated with 68Ga-PSMA-11 administration. PET-directed focal therapy alone led to a PSA drop of 50% or more in 31 of 39 (80%) patients. CONCLUSIONS AND RELEVANCE: Using blinded reads and independent lesion validation, we establish high PPV for 68Ga-PSMA-11 PET, detection rate and interreader agreement for localization of recurrent prostate cancer.

trial registrationClinicalTrials.gov identifiers: NCT02940262 and NCT03353740.

Indexed as

Positron-Emission TomographyAdultAgedAged, 80 and overEdetic AcidGallium IsotopesGallium RadioisotopesHumansMaleMiddle AgedNeoplasm Recurrence, LocalOligopeptidesPredictive Value of TestsProstate-Specific AntigenProstatic NeoplasmsRadiopharmaceuticalsEdetic Acidgallium 68 PSMA-11Gallium IsotopesGallium RadioisotopesOligopeptidesProstate-Specific AntigenRadiopharmaceuticals

Identifiers

PMID30920593
PMCPMC6567829

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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.