{"entity":{"id":"psma-prerp","kind":"trial","name":"PSMA-PreRP","aka":["68Ga-PSMA-11 PET before radical prostatectomy","16-001684"],"tldr":"The UCLA and UCSF scan study behind the first US approval of gallium PSMA PET: in men heading for prostate surgery it was very reliable when it called a pelvic lymph node positive, but it still missed about three in five of the nodes that pathology later found.","summary":"PSMA-PreRP is the US Illuccix label's name (Study 1) for the investigator-initiated, prospective, multicentre, single-arm, open-label phase 3 diagnostic-efficacy programme of 68Ga-PSMA-11 PET before planned radical prostatectomy at the University of California, San Francisco and the University of California, Los Angeles (Hope and colleagues, JAMA Oncology 2021; ClinicalTrials.gov NCT03368547, NCT02611882 and NCT02919111). From December 2015 to December 2019, men with intermediate- to high-risk prostate cancer had one PET scan with 3 to 7 mCi of 68Ga-PSMA-11. Each scan was read centrally by three blinded readers with a majority rule, and pelvic nodal findings were compared with histopathology after prostatectomy and pelvic lymph node dissection using nodal-region correlation.\n\nOf 764 men imaged, 277 (36 percent) went on to prostatectomy with lymph node dissection and formed the efficacy cohort; 75 of them (27 percent) had pelvic nodal metastasis on pathology. PET was positive for pelvic nodal, extrapelvic nodal and bone disease in 14, 1 and 3 percent. Per-patient sensitivity for pelvic nodal metastasis was 0.40 (95 percent CI 0.34 to 0.46), specificity 0.95 (0.92 to 0.97), positive predictive value 0.75 (0.70 to 0.80) and negative predictive value 0.81 (0.76 to 0.85). Of the 487 men who did not have surgery, most had radiotherapy (69 percent of those with follow-up) or systemic therapy (22 percent).\n\nThe authors state that the collaboration formed the foundation of the New Drug Application for 68Ga-PSMA-11, approved in December 2020. Telix's Illuccix kit (FDA December 2021) cites the programme as Study 1 (NCT03368547 and NCT02919111) and states that its efficacy for initial staging rests on that study of another gozetotide formulation; the label's own summary reports a 325-patient two-centre cut with 123 evaluable, which is a different analysis set from the paper's and is not used for the outcome rows here.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03368547","url":"https://clinicaltrials.gov/study/NCT03368547"},{"label":"ClinicalTrials.gov NCT02919111","url":"https://clinicaltrials.gov/study/NCT02919111"},{"label":"ClinicalTrials.gov NCT02611882","url":"https://clinicaltrials.gov/study/NCT02611882"},{"label":"JAMA Oncology 2021","url":"https://doi.org/10.1001/jamaoncol.2021.3771"},{"label":"Illuccix label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d4643b31-9b4f-673f-e053-2a95a90a559d"}],"tags":[],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":["psma-pet","pet-ct"],"targets":["psma"],"drugs":["illuccix","ga68-psma-11"],"companies":[],"institutions":["ucla-jonsson","ucsf"],"pathways":[],"terms":["sensitivity-specificity","ppv"],"trials":[],"people":["thomas-hope"],"bottlenecks":[],"keyPapers":["paper-psma-prerp-hope-jama-oncol-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03368547","phase":"3","setting":"Intermediate- to high-risk prostate cancer considered for radical prostatectomy: a single 68Ga-PSMA-11 PET scan for pelvic nodal staging, read against histopathology after prostatectomy and pelvic lymph node dissection","sponsor":"UCLA Jonsson Comprehensive Cancer Center and UCSF (investigator initiated)","result":"Per-patient sensitivity 0.40 (95% CI 0.34 to 0.46) and specificity 0.95 (0.92 to 0.97) for pelvic nodal metastasis against histopathology in the 277-man surgery cohort; positive predictive value 0.75, negative predictive value 0.81.","yearReported":2021,"enrolled":764,"enrolledBasis":"registered","enrolledNote":"The JAMA Oncology 2021 report covers 764 men imaged under three registrations (NCT03368547, NCT02919111 and NCT02611882), of whom 277 had surgery and formed the efficacy cohort; ClinicalTrials.gov NCT03368547 alone lists an actual enrolment of 400.","outcomes":[{"endpoint":"Sensitivity for pelvic nodal metastasis (per patient, nodal-region correlation, versus histopathology)","primary":true,"unit":"%","arms":[{"name":"68Ga-PSMA-11 PET","n":277,"value":40,"note":"Reported as 0.40; 95% CI 0.34 to 0.46; 75 of 277 men had nodal metastasis on pathology"}],"source":"https://doi.org/10.1001/jamaoncol.2021.3771"},{"endpoint":"Specificity for pelvic nodal metastasis (per patient, nodal-region correlation, versus histopathology)","primary":true,"unit":"%","arms":[{"name":"68Ga-PSMA-11 PET","n":277,"value":95,"note":"Reported as 0.95; 95% CI 0.92 to 0.97"}],"source":"https://doi.org/10.1001/jamaoncol.2021.3771"},{"endpoint":"Positive predictive value for pelvic nodal metastasis","unit":"%","arms":[{"name":"68Ga-PSMA-11 PET","n":277,"value":75,"note":"Reported as 0.75; 95% CI 0.70 to 0.80"}],"source":"https://doi.org/10.1001/jamaoncol.2021.3771"},{"endpoint":"Negative predictive value for pelvic nodal metastasis","unit":"%","arms":[{"name":"68Ga-PSMA-11 PET","n":277,"value":81,"note":"Reported as 0.81; 95% CI 0.76 to 0.85"}],"source":"https://doi.org/10.1001/jamaoncol.2021.3771"}],"replication":"proPSMA (Hofman, Lancet 2020; recorded as propsma) randomised PSMA PET/CT against conventional imaging for staging high-risk disease in Australia and found higher accuracy; OSPREY and CONDOR did the same job for the fluorine-18 tracer piflufolastat (Pylarify)."},"route":"/trials/psma-prerp/","neighbours":{"cancer":[{"id":"prostate-high-risk","kind":"cancer","name":"Localised prostate cancer, high and very high risk","route":"/cancers/prostate-high-risk/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"technology":[{"id":"pet-ct","kind":"technology","name":"PET/CT","route":"/technologies/pet-ct/"},{"id":"psma-pet","kind":"technology","name":"PSMA PET","route":"/technologies/psma-pet/"}],"target":[{"id":"psma","kind":"target","name":"PSMA","route":"/targets/psma/"}],"drug":[{"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/"}],"institution":[{"id":"ucla-jonsson","kind":"institution","name":"UCLA Jonsson Comprehensive Cancer Center","route":"/institutions/ucla-jonsson/"},{"id":"ucsf","kind":"institution","name":"UCSF Helen Diller Family Comprehensive Cancer Center","route":"/institutions/ucsf/"}],"term":[{"id":"ppv","kind":"term","name":"Positive predictive value (PPV)","route":"/terms/ppv/"},{"id":"sensitivity-specificity","kind":"term","name":"Sensitivity and specificity","route":"/terms/sensitivity-specificity/"}],"person":[{"id":"thomas-hope","kind":"person","name":"Thomas A. Hope","route":"/people/thomas-hope/"}],"paper":[{"id":"paper-psma-prerp-hope-jama-oncol-2021","kind":"paper","name":"Diagnostic accuracy of 68Ga-PSMA-11 PET for pelvic nodal metastasis detection prior to radical prostatectomy and pelvic lymph node dissection: a multicenter prospective phase 3 imaging trial","route":"/key-papers/paper-psma-prerp-hope-jama-oncol-2021/"}]}}