{"entity":{"id":"psma-pet-expression","kind":"biomarker","name":"PSMA expression by PET (PSMA-positive)","aka":["PSMA PET positive","PSMA-positive","PSMA expression","PSMA PET","Ga-68 PSMA-11 uptake","piflufolastat PET","PSMA-avid","PSMA uptake greater than liver"],"tldr":"PSMA-positive means prostate cancer deposits light up on a PSMA PET scan more than the liver does. It is the entry ticket for lutetium-177 PSMA therapy and the basis of the imaging that now stages most advanced prostate cancer.","summary":"Gallium-68 gozetotide (Locametz, Illuccix), piflufolastat F-18 (Pylarify) and flotufolastat F-18 (Posluma) image PSMA. The Pluvicto label requires selection with Locametz or another approved PSMA PET product based on PSMA expression in tumours; the VISION and PSMAfore trials defined positivity as at least one metastatic lesion with uptake greater than liver parenchyma and no PSMA-negative lesions above size limits (short axis 1 cm in soft tissue, 2.5 cm in nodes, or any measurable bone lesion with soft tissue component), and the label's clinical studies section repeats this. Pluvicto is now labelled for both PSMA-positive metastatic castration-resistant disease after an ARPI and, since 2026, PSMA-positive metastatic androgen pathway modulation-naive or -sensitive disease with an ARPI.","asOf":"2026-09-23","links":[{"label":"PLUVICTO prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14908037-2892-4d98-a053-253ce35afb1a"}],"tags":["biomarker","pet"],"related":["sstr-pet-expression","ar-v7-splice-variant"],"cancers":["prostate","prostate-mcrpc","prostate-mhspc","prostate-bcr"],"sections":[],"technologies":[],"targets":[],"drugs":["pluvicto","ga68-psma-11","locametz","illuccix","pylarify","flotufolastat","lu177-psma-it","ac225-psma"],"companies":[],"institutions":[],"pathways":[],"terms":["theranostics","prrt-term"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-silver-psma-expression-normal-malignant-tissues-ccr-1997","paper-propsma-hofman-lancet-2020","paper-fendler-psma-pet-biochemical-recurrence-jama-oncol-2019","paper-therap-lancet-2021"],"journals":[],"dependsOn":[],"notes":["Where PSMA sits in the body, from the tissue survey the imaging rests on: detectable in prostatic epithelium, duodenal mucosa, a subset of proximal renal tubules and colonic neuroendocrine cells, and undetectable in every other normal tissue including cerebral cortex and cerebellum; present in 33 of 35 primary prostate adenocarcinomas and 7 of 8 nodal metastases but only 8 of 18 bone metastases, with expression falling as tumours dedifferentiate (Silver 1997).","What the scan changes at staging: in 302 men randomised before curative-intent treatment, PSMA PET-CT was 27% more accurate than CT with bone scan, 92% against 65%, with sensitivity 85% against 38%, management change in 28% against 15%, fewer equivocal findings, 7% against 23%, and less radiation, 8.4 against 19.2 mSv (Hofman 2020).","What it changes at biochemical recurrence: recurrence was localised in 475 of 635 men, 75%, with detection rising from 38% below PSA 0.5 ng/mL to 97% at 5.0 or above, and positive predictive value 0.84 by histopathology (Fendler 2019).","How many men it excludes from radioligand therapy: of 291 men screened for TheraP with PSMA and FDG PET, 200, 69%, were eligible, the rest excluded for PSMA-low disease or FDG-positive PSMA-negative sites (Hofman 2021)."],"target":"psma","measurement":"pet-tracer-expression","scoringRule":{"text":"At least one metastatic lesion with PSMA PET uptake greater than normal liver, and no PSMA-negative measurable lesions (the VISION criteria) on an approved PSMA PET tracer.","quote":"Select patients for treatment using LOCAMETZ ® or another approved PSMA positron emission tomography (PET) product based on PSMA expression in tumors.","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14908037-2892-4d98-a053-253ce35afb1a","sourceLabel":"PLUVICTO prescribing information"},"thresholds":[{"value":"PSMA-positive by PSMA PET","drugId":"pluvicto","cancerId":"prostate-mcrpc","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14908037-2892-4d98-a053-253ce35afb1a","quote":"for the treatment of adult patients with PSMA-positive metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer who have been treated with ARPI therapy, and are considered appropriate to delay taxane-based chemotherapy, or have received prior taxane-based chemotherapy.","status":"current"},{"value":"PSMA-positive by PSMA PET","drugId":"pluvicto","cancerId":"prostate-mhspc","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14908037-2892-4d98-a053-253ce35afb1a","quote":"in combination with androgen receptor pathway inhibitor (ARPI) therapy for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer.","status":"current"}],"tests":[],"assays":["psma-pet-selection"],"companionDiagnostics":[],"forPatient":"A PSMA PET scan that shows your cancer taking up the tracer more strongly than your liver makes you PSMA-positive, which is required for lutetium-177 PSMA treatment. The same scan is used to find where the cancer is. If some deposits do not take up the tracer, the treatment may not reach them, which is why the scan is read lesion by lesion."},"route":"/biomarkers/psma-pet-expression/","neighbours":{"biomarker":[{"id":"ar-v7-splice-variant","kind":"biomarker","name":"AR-V7 splice variant","route":"/biomarkers/ar-v7-splice-variant/"},{"id":"sstr-pet-expression","kind":"biomarker","name":"Somatostatin receptor expression by PET (SSTR-positive)","route":"/biomarkers/sstr-pet-expression/"}],"cancer":[{"id":"prostate-bcr","kind":"cancer","name":"Biochemical recurrence of prostate cancer","route":"/cancers/prostate-bcr/"},{"id":"prostate-mcrpc","kind":"cancer","name":"Metastatic castration-resistant prostate cancer","route":"/cancers/prostate-mcrpc/"},{"id":"prostate-mhspc","kind":"cancer","name":"Metastatic hormone-sensitive prostate cancer","route":"/cancers/prostate-mhspc/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"drug":[{"id":"lu177-psma-it","kind":"drug","name":"177Lu-PSMA-I&T","route":"/drugs/lu177-psma-it/"},{"id":"ac225-psma","kind":"drug","name":"Actinium-225 PSMA agents","route":"/drugs/ac225-psma/"},{"id":"flotufolastat","kind":"drug","name":"Flotufolastat F-18","route":"/drugs/flotufolastat/"},{"id":"ga68-psma-11","kind":"drug","name":"Gallium-68 gozetotide (PSMA-11)","route":"/drugs/ga68-psma-11/"},{"id":"illuccix","kind":"drug","name":"Illuccix (kit for Ga-68 gozetotide)","route":"/drugs/illuccix/"},{"id":"locametz","kind":"drug","name":"Locametz (kit for Ga-68 gozetotide)","route":"/drugs/locametz/"},{"id":"pluvicto","kind":"drug","name":"Lutetium-177 vipivotide tetraxetan","route":"/drugs/pluvicto/"},{"id":"pylarify","kind":"drug","name":"Piflufolastat F-18 / Pylarify TruVu","route":"/drugs/pylarify/"}],"term":[{"id":"prrt-term","kind":"term","name":"PRRT (peptide receptor radionuclide therapy)","route":"/terms/prrt-term/"},{"id":"theranostics","kind":"term","name":"Theranostics","route":"/terms/theranostics/"}],"paper":[{"id":"paper-therap-lancet-2021","kind":"paper","name":"[ 177 Lu]Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP): a randomised, open-label, phase 2 trial","route":"/key-papers/paper-therap-lancet-2021/"},{"id":"paper-fendler-psma-pet-biochemical-recurrence-jama-oncol-2019","kind":"paper","name":"Accuracy of gallium-68 PSMA-11 PET in localising recurrent prostate cancer: a prospective single-arm clinical trial","route":"/key-papers/paper-fendler-psma-pet-biochemical-recurrence-jama-oncol-2019/"},{"id":"paper-propsma-hofman-lancet-2020","kind":"paper","name":"proPSMA: PSMA PET-CT versus conventional imaging for staging high-risk prostate cancer","route":"/key-papers/paper-propsma-hofman-lancet-2020/"},{"id":"paper-silver-psma-expression-normal-malignant-tissues-ccr-1997","kind":"paper","name":"Prostate-specific membrane antigen expression in normal and malignant human tissues","route":"/key-papers/paper-silver-psma-expression-normal-malignant-tissues-ccr-1997/"}],"target":[{"id":"psma","kind":"target","name":"PSMA","route":"/targets/psma/"}]}}