Effect of [68Ga]Ga-PSMA-11 PET-CT in the diagnosis of prostate cancer in men with equivocal or clinically high-risk non-suspicious findings on multiparametric MRI (PRIMARY2): a multicentre, non-inferiority, phase 3, randomised controlled trial.

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Title: Effect of [68Ga]Ga-PSMA-11 PET-CT in the diagnosis of prostate cancer in men with equivocal or clinically high-risk non-suspicious findings on multiparametric MRI (PRIMARY2): a multicentre, non-inferiority, phase 3, randomised controlled trial.
Authors: Buteau JP; Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC), Molecular Imaging and Therapeutic Nuclear Medicine, Cancer Imaging, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia., Moon D; Division of Cancer Surgery, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; University of Melbourne, Royal Melbourne Clinical School, Melbourne, VIC, Australia., Fahey MT; Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia., Roberts MJ; Department of Urology, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia; Faculty of Health, Medicine and Behavioural Sciences, University of Queensland, Brisbane, QLD, Australia., Ayati N; Department of Theranostics and Nuclear Medicine, St Vincent's Hospital, Sydney, NSW, Australia; St Vincent's Clinical School, University of New South Wales, Sydney, NSW, Australia., Papa N; Department of Theranostics and Nuclear Medicine, St Vincent's Hospital, Sydney, NSW, Australia; Garvan Institute of Medical Research, Sydney, NSW, Australia., Murphy DG; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia; Division of Cancer Surgery, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia., Kasivisvanathan V; Division of Cancer Surgery, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Division of Surgery and Interventional Science, University College London, London, UK; Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria., Dhillon HM; Psycho-Oncology Cooperative Research Group, School of Psychology, Faculty of Science, The University of Sydney, Sydney, NSW, Australia., Du YT; Department of Nuclear Medicine, PET and Bone Densitometry, Royal Adelaide Hospital, Adelaide, SA, Australia., Dundee P; University of Melbourne, Royal Melbourne Clinical School, Melbourne, VIC, Australia., Foudoulis J; Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia., Hennes D; Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC), Molecular Imaging and Therapeutic Nuclear Medicine, Cancer Imaging, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia., Hutton AC; St George Clinical School, University of New South Wales, Sydney, NSW, Australia., Idiare J; Department of Theranostics and Nuclear Medicine, St Vincent's Hospital, Sydney, NSW, Australia., Jack G; Department of Surgery, Austin Health, Melbourne, VIC, Australia., Kamath S; Department of Urology, Royal Darwin Hospital, Darwin, NT, Australia., Lee SN; Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia., Lee SF; Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC), Molecular Imaging and Therapeutic Nuclear Medicine, Cancer Imaging, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia., Lee ST; Department of Molecular Imaging and Therapy, Austin Health, Melbourne, VIC, Australia., Leslie S; Department of Urology, Chris O'Brien Lifehouse, Sydney, NSW, Australia; Faculty of Medicine, University of Sydney, Sydney, NSW, Australia., Levy SM; Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC), Molecular Imaging and Therapeutic Nuclear Medicine, Cancer Imaging, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia., Link E; Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia., Mitchell C; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia; Department of Pathology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia., Morigi JJ; Molecular Imaging Unit, Royal Darwin Hospital, Darwin, NT, Australia., Nguyen A; Department of Theranostics and Nuclear Medicine, St Vincent's Hospital, Sydney, NSW, Australia; St Vincent's Clinical School, University of New South Wales, Sydney, NSW, Australia., Olphert J; St George Clinical School, University of New South Wales, Sydney, NSW, Australia., Patel MI; Department of Urology, Westmead Hospital, University of Sydney, Sydney, NSW, Australia., Pattison DA; Department of Nuclear Medicine and PET Services, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia; School of Medicine, University of Queensland, Brisbane, QLD, Australia., Pearce A; Department of Urology, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia., Perera M; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia; Division of Cancer Surgery, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Department of Surgery, Austin Health, Melbourne, VIC, Australia., Thanigasalam R; Department of Urology, Chris O'Brien Lifehouse, Sydney, NSW, Australia; Concord Clinical School, University of Sydney, Sydney, NSW, Australia., Thomson A; Division of Cancer Surgery, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia., Yaxley J; Department of Urology, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia; Faculty of Health, Medicine and Behavioural Sciences, University of Queensland, Brisbane, QLD, Australia., Thompson J; St George Clinical School, University of New South Wales, Sydney, NSW, Australia., Hofman MS; Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC), Molecular Imaging and Therapeutic Nuclear Medicine, Cancer Imaging, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia. Electronic address: michael.hofman@petermac.org., Emmett L; Department of Theranostics and Nuclear Medicine, St Vincent's Hospital, Sydney, NSW, Australia; St Vincent's Clinical School, University of New South Wales, Sydney, NSW, Australia; Garvan Institute of Medical Research, Sydney, NSW, Australia.
Corporate Authors: PRIMARY2 Trial Investigators
Source: The Lancet. Oncology [Lancet Oncol] 2026 Jul; Vol. 27 (7), pp. 839-848. Date of Electronic Publication: 2026 Jun 10.
Publication Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Clinical Trial, Phase III; Equivalence Trial
Journal Info: Publisher: Lancet Pub. Group Country of Publication: England NLM ID: 100957246 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1474-5488 (Electronic) Linking ISSN: 14702045 NLM ISO Abbreviation: Lancet Oncol Subsets: MEDLINE
Database: MEDLINE Ultimate
Description
ISSN:1474-5488
DOI:10.1016/S1470-2045(26)00120-8