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. |
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| 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 |
| FullText | Text: Availability: 0 |
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| Header | DbId: mdl DbLabel: MEDLINE Ultimate An: 42269655 AccessLevel: 2 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Effect of [<superscript>68</superscript>Ga]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. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AU" term="%22Buteau+JP%22">Buteau JP</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Moon+D%22">Moon D</searchLink>; Division of Cancer Surgery, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; University of Melbourne, Royal Melbourne Clinical School, Melbourne, VIC, Australia.<br /><searchLink fieldCode="AU" term="%22Fahey+MT%22">Fahey MT</searchLink>; Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.<br /><searchLink fieldCode="AU" term="%22Roberts+MJ%22">Roberts MJ</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Ayati+N%22">Ayati N</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Papa+N%22">Papa N</searchLink>; Department of Theranostics and Nuclear Medicine, St Vincent's Hospital, Sydney, NSW, Australia; Garvan Institute of Medical Research, Sydney, NSW, Australia.<br /><searchLink fieldCode="AU" term="%22Murphy+DG%22">Murphy DG</searchLink>; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia; Division of Cancer Surgery, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.<br /><searchLink fieldCode="AU" term="%22Kasivisvanathan+V%22">Kasivisvanathan V</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Dhillon+HM%22">Dhillon HM</searchLink>; Psycho-Oncology Cooperative Research Group, School of Psychology, Faculty of Science, The University of Sydney, Sydney, NSW, Australia.<br /><searchLink fieldCode="AU" term="%22Du+YT%22">Du YT</searchLink>; Department of Nuclear Medicine, PET and Bone Densitometry, Royal Adelaide Hospital, Adelaide, SA, Australia.<br /><searchLink fieldCode="AU" term="%22Dundee+P%22">Dundee P</searchLink>; University of Melbourne, Royal Melbourne Clinical School, Melbourne, VIC, Australia.<br /><searchLink fieldCode="AU" term="%22Foudoulis+J%22">Foudoulis J</searchLink>; Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.<br /><searchLink fieldCode="AU" term="%22Hennes+D%22">Hennes D</searchLink>; Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC), Molecular Imaging and Therapeutic Nuclear Medicine, Cancer Imaging, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.<br /><searchLink fieldCode="AU" term="%22Hutton+AC%22">Hutton AC</searchLink>; St George Clinical School, University of New South Wales, Sydney, NSW, Australia.<br /><searchLink fieldCode="AU" term="%22Idiare+J%22">Idiare J</searchLink>; Department of Theranostics and Nuclear Medicine, St Vincent's Hospital, Sydney, NSW, Australia.<br /><searchLink fieldCode="AU" term="%22Jack+G%22">Jack G</searchLink>; Department of Surgery, Austin Health, Melbourne, VIC, Australia.<br /><searchLink fieldCode="AU" term="%22Kamath+S%22">Kamath S</searchLink>; Department of Urology, Royal Darwin Hospital, Darwin, NT, Australia.<br /><searchLink fieldCode="AU" term="%22Lee+SN%22">Lee SN</searchLink>; Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.<br /><searchLink fieldCode="AU" term="%22Lee+SF%22">Lee SF</searchLink>; Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC), Molecular Imaging and Therapeutic Nuclear Medicine, Cancer Imaging, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.<br /><searchLink fieldCode="AU" term="%22Lee+ST%22">Lee ST</searchLink>; Department of Molecular Imaging and Therapy, Austin Health, Melbourne, VIC, Australia.<br /><searchLink fieldCode="AU" term="%22Leslie+S%22">Leslie S</searchLink>; Department of Urology, Chris O'Brien Lifehouse, Sydney, NSW, Australia; Faculty of Medicine, University of Sydney, Sydney, NSW, Australia.<br /><searchLink fieldCode="AU" term="%22Levy+SM%22">Levy SM</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Link+E%22">Link E</searchLink>; Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.<br /><searchLink fieldCode="AU" term="%22Mitchell+C%22">Mitchell C</searchLink>; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia; Department of Pathology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.<br /><searchLink fieldCode="AU" term="%22Morigi+JJ%22">Morigi JJ</searchLink>; Molecular Imaging Unit, Royal Darwin Hospital, Darwin, NT, Australia.<br /><searchLink fieldCode="AU" term="%22Nguyen+A%22">Nguyen A</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Olphert+J%22">Olphert J</searchLink>; St George Clinical School, University of New South Wales, Sydney, NSW, Australia.<br /><searchLink fieldCode="AU" term="%22Patel+MI%22">Patel MI</searchLink>; Department of Urology, Westmead Hospital, University of Sydney, Sydney, NSW, Australia.<br /><searchLink fieldCode="AU" term="%22Pattison+DA%22">Pattison DA</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Pearce+A%22">Pearce A</searchLink>; Department of Urology, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.<br /><searchLink fieldCode="AU" term="%22Perera+M%22">Perera M</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Thanigasalam+R%22">Thanigasalam R</searchLink>; Department of Urology, Chris O'Brien Lifehouse, Sydney, NSW, Australia; Concord Clinical School, University of Sydney, Sydney, NSW, Australia.<br /><searchLink fieldCode="AU" term="%22Thomson+A%22">Thomson A</searchLink>; Division of Cancer Surgery, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.<br /><searchLink fieldCode="AU" term="%22Yaxley+J%22">Yaxley J</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Thompson+J%22">Thompson J</searchLink>; St George Clinical School, University of New South Wales, Sydney, NSW, Australia.<br /><searchLink fieldCode="AU" term="%22Hofman+MS%22">Hofman MS</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Emmett+L%22">Emmett L</searchLink>; 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. – Name: AuthorCorporate Label: Corporate Authors Group: Au Data: <searchLink fieldCode="CA" term="%22PRIMARY2+Trial+Investigators%22">PRIMARY2 Trial Investigators</searchLink> – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22100957246%22">The Lancet. Oncology</searchLink> [Lancet Oncol] 2026 Jul; Vol. 27 (7), pp. 839-848. <i>Date of Electronic Publication: </i>2026 Jun 10. – Name: TypePub Label: Publication Type Group: TypPub Data: Journal Article; Multicenter Study; Randomized Controlled Trial; Clinical Trial, Phase III; Equivalence Trial – Name: TitleSource Label: Journal Info Group: Src Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Lancet+Pub%2E+Group%22">Lancet Pub. Group </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>100957246 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1474-5488 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2214702045%22">14702045 </searchLink><i>NLM ISO Abbreviation: </i>Lancet Oncol <i>Subsets: </i>MEDLINE |
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