Please use this identifier to cite or link to this item: http://ahro.austin.org.au/austinjspui/handle/1/22885
Title: Prostate-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.
Authors: Hofman, Michael S;Lawrentschuk, Nathan;Francis, Roslyn J;Tang, Colin;Vela, Ian;Thomas, Paul;Rutherford, Natalie;Martin, Jarad M;Frydenberg, Mark;Shakher, Ramdave;Wong, Lih-Ming;Taubman, Kim;Lee, Sze Ting;Hsiao, Edward;Roach, Paul;Nottage, Michelle;Kirkwood, Ian;Hayne, Dickon;Link, Emma;Marusic, Petra;Matera, Anetta;Herschtal, Alan;Iravani, Amir;Hicks, Rodney J;Williams, Scott;Murphy, Declan G
Affiliation: Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Australia
Department of Nuclear Medicine, Hunter New England Health, Newcastle, NSW, Australia
Department of Urology, Princess Alexandra Hospital, Australian Prostate Cancer Research Centre-Queensland, Queensland University of Technology, Translational Research Institute, Brisbane, QLD, Australia
Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia
Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia
Department of Surgery, Austin Health, Heidelberg, Victoria, Australia
Department of Nuclear Medicine, Sir Charles Gairdner Hospital, Perth, WA, Australia
University of Western Australia, Faculty of Health and Medical Sciences, Perth, WA, Australia
Department of Nuclear Medicine, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia
Clinical and Research Imaging Centre, South Australian Health and Medical Research Institute, Adelaide, SA, Australia
Department of Nuclear Medicine and PET, Royal Adelaide Hospital, Adelaide, SA, Australia
Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia
Division of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia
Division of Cancer Surgery, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia
University of Sydney, Department of Nuclear Medicine and PET, Royal North Shore Hospital, Sydney, NSW, Australia
Department of Molecular Imaging and Therapy, Austin Health, Heidelberg, Victoria, Australia
Department of Medical Imaging, PET/CT and St Vincent's Private Radiology, St Vincent's Health, Melbourne, VIC, Australia
Department of Urology and Surgery, St Vincent's Health Melbourne, University of Melbourne, Melbourne, VIC, Australia
Monash Health Imaging, Monash Health, Melbourne, VIC, Australia
Department of Surgery, Monash University and Cabrini Institute, Cabrini Health, Melbourne, VIC, Australia
UWA Medical School, University of Western Australia, Perth, WA, Australia
Australian and New Zealand Urogenital and Prostate Cancer Trials Group, NSW, Australia
Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, SA, Australia
Dr Jones and Partners Medical Imaging, Adelaide, SA, Australia
Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia
ARTnet, NSW, Australia
Urological Society of Australia and New Zealand, NSW, Australia
School of Medicine and Public Health, University of Newcastle, Newcastle, NSW, Australia
Issue Date: 2020
EDate: 2020-03-20
Citation: Lancet (London, England) 2020; 395(10231): 1208-1216
Abstract: Conventional 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.
URI: http://ahro.austin.org.au/austinjspui/handle/1/22885
DOI: 10.1016/S0140-6736(20)30314-7
ORCID: 0000-0001-8553-5618
0000-0001-8641-456X
PubMed URL: 32209449
Type: Journal Article
Appears in Collections:Journal articles

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