Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/22885
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dc.contributor.authorHofman, Michael S-
dc.contributor.authorLawrentschuk, Nathan-
dc.contributor.authorFrancis, Roslyn J-
dc.contributor.authorTang, Colin-
dc.contributor.authorVela, Ian-
dc.contributor.authorThomas, Paul-
dc.contributor.authorRutherford, Natalie-
dc.contributor.authorMartin, Jarad M-
dc.contributor.authorFrydenberg, Mark-
dc.contributor.authorShakher, Ramdave-
dc.contributor.authorWong, Lih-Ming-
dc.contributor.authorTaubman, Kim-
dc.contributor.authorLee, Sze Ting-
dc.contributor.authorHsiao, Edward-
dc.contributor.authorRoach, Paul-
dc.contributor.authorNottage, Michelle-
dc.contributor.authorKirkwood, Ian-
dc.contributor.authorHayne, Dickon-
dc.contributor.authorLink, Emma-
dc.contributor.authorMarusic, Petra-
dc.contributor.authorMatera, Anetta-
dc.contributor.authorHerschtal, Alan-
dc.contributor.authorIravani, Amir-
dc.contributor.authorHicks, Rodney J-
dc.contributor.authorWilliams, Scott-
dc.contributor.authorMurphy, Declan G-
dc.date2020-03-20-
dc.date.accessioned2020-03-31T03:15:24Z-
dc.date.available2020-03-31T03:15:24Z-
dc.date.issued2020-
dc.identifier.citationLancet (London, England) 2020; 395(10231): 1208-1216-
dc.identifier.urihttp://ahro.austin.org.au/austinjspui/handle/1/22885-
dc.description.abstractConventional imaging using CT and bone scan has insufficient sensitivity when staging men with high-risk localised prostate cancer. We aimed to investigate whether novel imaging using prostate-specific membrane antigen (PSMA) PET-CT might improve accuracy and affect management. In this multicentre, two-arm, randomised study, we recruited men with biopsy-proven prostate cancer and high-risk features at ten hospitals in Australia. Patients were randomly assigned to conventional imaging with CT and bone scanning or gallium-68 PSMA-11 PET-CT. First-line imaging was done within 21 days following randomisation. Patients crossed over unless three or more distant metastases were identified. The primary outcome was accuracy of first-line imaging for identifying either pelvic nodal or distant-metastatic disease defined by the receiver-operating curve using a predefined reference-standard including histopathology, imaging, and biochemistry at 6-month follow-up. This trial is registered with the Australian New Zealand Clinical Trials Registry, ANZCTR12617000005358. From March 22, 2017 to Nov 02, 2018, 339 men were assessed for eligibility and 302 men were randomly assigned. 152 (50%) men were randomly assigned to conventional imaging and 150 (50%) to PSMA PET-CT. Of 295 (98%) men with follow-up, 87 (30%) had pelvic nodal or distant metastatic disease. PSMA PET-CT had a 27% (95% CI 23-31) greater accuracy than that of conventional imaging (92% [88-95] vs 65% [60-69]; p<0·0001). We found a lower sensitivity (38% [24-52] vs 85% [74-96]) and specificity (91% [85-97] vs 98% [95-100]) for conventional imaging compared with PSMA PET-CT. Subgroup analyses also showed the superiority of PSMA PET-CT (area under the curve of the receiver operating characteristic curve 91% vs 59% [32% absolute difference; 28-35] for patients with pelvic nodal metastases, and 95% vs 74% [22% absolute difference; 18-26] for patients with distant metastases). First-line conventional imaging conferred management change less frequently (23 [15%] men [10-22] vs 41 [28%] men [21-36]; p=0·008) and had more equivocal findings (23% [17-31] vs 7% [4-13]) than PSMA PET-CT did. Radiation exposure was 10·9 mSv (95% CI 9·8-12·0) higher for conventional imaging than for PSMA PET-CT (19·2 mSv vs 8·4 mSv; p<0·001). We found high reporter agreement for PSMA PET-CT (κ=0·87 for nodal and κ=0·88 for distant metastases). In patients who underwent second-line image, management change occurred in seven (5%) of 136 patients following conventional imaging, and in 39 (27%) of 146 following PSMA PET-CT. PSMA PET-CT is a suitable replacement for conventional imaging, providing superior accuracy, to the combined findings of CT and bone scanning. Movember and Prostate Cancer Foundation of Australia. VIDEO ABSTRACT.-
dc.language.isoeng-
dc.titleProstate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multi-centre study.-
dc.typeJournal Article-
dc.identifier.journaltitleLancet (London, England)-
dc.identifier.affiliationDepartment of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Australiaen
dc.identifier.affiliationDepartment of Nuclear Medicine, Hunter New England Health, Newcastle, NSW, Australiaen
dc.identifier.affiliationDepartment of Urology, Princess Alexandra Hospital, Australian Prostate Cancer Research Centre-Queensland, Queensland University of Technology, Translational Research Institute, Brisbane, QLD, Australiaen
dc.identifier.affiliationMolecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australiaen
dc.identifier.affiliationSir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australiaen
dc.identifier.affiliationDepartment of Surgery, Austin Health, Heidelberg, Victoria, Australiaen
dc.identifier.affiliationDepartment of Nuclear Medicine, Sir Charles Gairdner Hospital, Perth, WA, Australiaen
dc.identifier.affiliationUniversity of Western Australia, Faculty of Health and Medical Sciences, Perth, WA, Australiaen
dc.identifier.affiliationDepartment of Nuclear Medicine, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australiaen
dc.identifier.affiliationClinical and Research Imaging Centre, South Australian Health and Medical Research Institute, Adelaide, SA, Australiaen
dc.identifier.affiliationDepartment of Nuclear Medicine and PET, Royal Adelaide Hospital, Adelaide, SA, Australiaen
dc.identifier.affiliationCentre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australiaen
dc.identifier.affiliationDivision of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australiaen
dc.identifier.affiliationDivision of Cancer Surgery, Peter MacCallum Cancer Centre, Melbourne, VIC, Australiaen
dc.identifier.affiliationUniversity of Sydney, Department of Nuclear Medicine and PET, Royal North Shore Hospital, Sydney, NSW, Australiaen
dc.identifier.affiliationDepartment of Molecular Imaging and Therapy, Austin Health, Heidelberg, Victoria, Australiaen
dc.identifier.affiliationDepartment of Medical Imaging, PET/CT and St Vincent's Private Radiology, St Vincent's Health, Melbourne, VIC, Australiaen
dc.identifier.affiliationDepartment of Urology and Surgery, St Vincent's Health Melbourne, University of Melbourne, Melbourne, VIC, Australiaen
dc.identifier.affiliationMonash Health Imaging, Monash Health, Melbourne, VIC, Australiaen
dc.identifier.affiliationDepartment of Surgery, Monash University and Cabrini Institute, Cabrini Health, Melbourne, VIC, Australiaen
dc.identifier.affiliationUWA Medical School, University of Western Australia, Perth, WA, Australiaen
dc.identifier.affiliationAustralian and New Zealand Urogenital and Prostate Cancer Trials Group, NSW, Australiaen
dc.identifier.affiliationFaculty of Health and Medical Sciences, University of Adelaide, Adelaide, SA, Australiaen
dc.identifier.affiliationDr Jones and Partners Medical Imaging, Adelaide, SA, Australiaen
dc.identifier.affiliationFaculty of Medicine, University of Queensland, Brisbane, QLD, Australiaen
dc.identifier.affiliationARTnet, NSW, Australiaen
dc.identifier.affiliationUrological Society of Australia and New Zealand, NSW, Australiaen
dc.identifier.affiliationSchool of Medicine and Public Health, University of Newcastle, Newcastle, NSW, Australiaen
dc.identifier.doi10.1016/S0140-6736(20)30314-7-
dc.identifier.orcid0000-0001-8553-5618en
dc.identifier.orcid0000-0001-8641-456Xen
dc.identifier.pubmedid32209449-
dc.type.austinJournal Article-
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