Journal article
Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer: A Prospective Single-Arm Clinical Trial.
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Fendler WP
Ahmanson Translational Imaging Division, Department of Molecular and Medical Pharmacology, University of California Los Angeles, Los Angeles.
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Calais J
Ahmanson Translational Imaging Division, Department of Molecular and Medical Pharmacology, University of California Los Angeles, Los Angeles.
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Eiber M
Ahmanson Translational Imaging Division, Department of Molecular and Medical Pharmacology, University of California Los Angeles, Los Angeles.
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Flavell RR
Departments of Radiology and Biomedical Imaging and Pharmaceutical Chemistry, University of California San Francisco, San Francisco.
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Mishoe A
Departments of Radiology and Biomedical Imaging and Pharmaceutical Chemistry, University of California San Francisco, San Francisco.
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Feng FY
Department of Urology, University of California San Francisco, San Francisco.
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Nguyen HG
Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco.
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Reiter RE
Department of Urology, UCLA Medical Center, University of California Los Angeles, Los Angeles.
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Rettig MB
Department of Urology, UCLA Medical Center, University of California Los Angeles, Los Angeles.
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Okamoto S
Department of Radiology, Obihiro Kosei Hospital, Obihiro, Japan.
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Emmett L
Department of Theranostics and Nuclear Medicine, St Vincent's Hospital, Sydney, Australia.
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Zacho HD
Department of Nuclear Medicine, Aalborg University Hospital, Aalborg, Denmark.
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Ilhan H
Department of Nuclear Medicine, Ludwig-Maximilians-University Munich, Munich, Germany.
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Wetter A
Department of Diagnostic and Interventional Radiology and Neuroradiology, University of Duisburg-Essen, Essen, Germany.
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Rischpler C
Department of Nuclear Medicine, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
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Schoder H
Molecular Imaging and Therapy Service, Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York.
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Burger IA
Department of Nuclear Medicine, University Hospital Zürich, University of Zürich, Switzerland.
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Gartmann J
Ahmanson Translational Imaging Division, Department of Molecular and Medical Pharmacology, University of California Los Angeles, Los Angeles.
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Smith R
Departments of Radiology and Biomedical Imaging and Pharmaceutical Chemistry, University of California San Francisco, San Francisco.
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Small EJ
Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco.
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Slavik R
Ahmanson Translational Imaging Division, Department of Molecular and Medical Pharmacology, University of California Los Angeles, Los Angeles.
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Carroll PR
Department of Urology, University of California San Francisco, San Francisco.
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Herrmann K
Ahmanson Translational Imaging Division, Department of Molecular and Medical Pharmacology, University of California Los Angeles, Los Angeles.
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Czernin J
Ahmanson Translational Imaging Division, Department of Molecular and Medical Pharmacology, University of California Los Angeles, Los Angeles.
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Hope TA
Departments of Radiology and Biomedical Imaging and Pharmaceutical Chemistry, University of California San Francisco, San Francisco.
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English
Importance
In retrospective studies, 68Ga-PSMA-11 positron emission tomographic (PET) imaging improves detection of biochemically recurrent prostate cancer compared with conventional imaging.
Objective
To assess 68Ga-PSMA-11 PET accuracy in a prospective multicenter trial.
Design, Setting, and Participants
In 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.
Results
A 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 Registration
ClinicalTrials.gov identifiers: NCT02940262 and NCT03353740.
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Language
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Open access status
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bronze
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Identifiers
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Persistent URL
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https://sonar.ch/global/documents/153086
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