2020
DOI: 10.1200/jco.2020.38.15_suppl.5502
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Accuracy of 68Ga-PSMA-11 for pelvic nodal metastasis detection prior to radical prostatectomy and pelvic lymph node dissection: A multicenter prospective phase III imaging study.

Abstract: 5502 Background: To determine the accuracy of 68Ga-PSMA-11 PET for the detection of pelvic nodal metastases (N1) compared to histopathology at time of radical prostatectomy (RP). Methods: This is a prospective multicenter single-arm open-label phase 3 imaging trial. Patients with intermediate to high risk prostate cancer (PCa) considered for RP with lymph node dissection (PLND) were enrolled at the University of California, Los Angeles (UCLA) and at the San Francisco (UCSF) (NCT03368547, NCT02611882, NCT02919… Show more

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Cited by 35 publications
(31 citation statements)
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“…The OSPREY sensitivity and specificity results also are comparable to those from the similarly designed pivotal trial for 68 Ga-PSMA-11. 28 Limitations of this study are several-fold. Chief among them is intrinsic to any diagnostic study in which the gold standard is histopathology.…”
Section: Discussionmentioning
confidence: 94%
“…The OSPREY sensitivity and specificity results also are comparable to those from the similarly designed pivotal trial for 68 Ga-PSMA-11. 28 Limitations of this study are several-fold. Chief among them is intrinsic to any diagnostic study in which the gold standard is histopathology.…”
Section: Discussionmentioning
confidence: 94%
“…This generates several bioequivalent options that should allow greater availability, especially in view of the recent randomized clinical trial data for staging PC (proPSMA study) [55]. However, sensitivity in lymph node detection is a likely overestimate when considered against prospectively conducted surgical series [56,57] and verification bias remains problematic, making it difficult to interpret the false negative rates of PSMA PET.…”
Section: Discussionmentioning
confidence: 99%
“…As such, while 18 F fluciclovine is only approved for use in patients with suspected cancer recurrence, 68 Ga PSMA-11 has an expanded approval indication that also includes patients with suspected metastases who are candidates for initial definitive therapy. Although the sensitivity of 68 Ga PSMA-11 PET scans is reported to be 40% (44% upon adjustment for positive lymph nodes unable to be harvested at surgery) in patients with intermediate-to high-risk prostate cancer at initial staging [4], this is still substantially higher than the limited sensitivity achieved by conventional imaging techniques [5].…”
Section: New Imaging Agents For Prostate Cancermentioning
confidence: 95%
“…The approval of 68 Ga PSMA-11 has generated substantial enthusiasm in the field, as this is the first authorization of a PSMA-targeted PET imaging drug and provides an additional imaging approach to detect cancer that has potentially spread to other areas of the body [4]. As such, while 18 F fluciclovine is only approved for use in patients with suspected cancer recurrence, 68 Ga PSMA-11 has an expanded approval indication that also includes patients with suspected metastases who are candidates for initial definitive therapy.…”
Section: New Imaging Agents For Prostate Cancermentioning
confidence: 99%