# 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

Source: https://onco.cc/key-papers/paper-psma-prerp-hope-jama-oncol-2021/  
OnCo record `paper-psma-prerp-hope-jama-oncol-2021` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

In 277 men whose prostate and pelvic lymph nodes were removed after a gallium PSMA scan, the scan correctly flagged 40 percent of the men with cancer in their nodes and was right 95 percent of the time when it called the nodes clear.

## Summary

Report of the investigator-initiated, prospective, multicentre, single-arm, open-label phase 3 imaging trial of 68Ga-PSMA-11 PET at UCSF and UCLA (NCT03368547, NCT02611882 and NCT02919111), which enrolled 764 men with intermediate- to high-risk prostate cancer considered for prostatectomy between December 2015 and December 2019. Each man had one PET scan with 3 to 7 mCi of 68Ga-PSMA-11, read by three blinded central readers with a majority rule. The primary endpoint was per-patient sensitivity and specificity for pelvic lymph node metastasis against histopathology, with nodal-region correlation.

Of the 764 men, 277 (36 percent) underwent prostatectomy with lymph node dissection and formed the efficacy cohort; 75 (27 percent) had pelvic nodal metastasis on pathology. PET was positive in 40 (14 percent), 2 (1 percent) and 7 (3 percent) of the 277 for pelvic nodal, extrapelvic nodal and bone disease. Sensitivity, specificity, positive predictive value and negative predictive value for pelvic nodal metastasis were 0.40 (95 percent CI 0.34 to 0.46), 0.95 (0.92 to 0.97), 0.75 (0.70 to 0.80) and 0.81 (0.76 to 0.85). Of the 487 men who did not have surgery, 108 were lost to follow-up; the rest mostly had radiotherapy (69 percent) or systemic therapy (22 percent). The authors describe the collaboration as the largest of its kind and the foundation of the New Drug Application for 68Ga-PSMA-11.

## Fields

- Kind: Key paper
- Last checked: 2026-09-24
- Journal: JAMA Oncology
- Year: 2021
- DOI: 10.1001/jamaoncol.2021.3771
- Authors: Hope TA, Eiber M, Armstrong WR, et al.
- Findings: Per-patient sensitivity 0.40 (95 percent CI 0.34 to 0.46) and specificity 0.95 (0.92 to 0.97) for pelvic nodal metastasis against histopathology in 277 men.; Positive predictive value 0.75 and negative predictive value 0.81; 27 percent of the surgery cohort had nodal metastasis.; 764 men imaged; 36 percent went on to prostatectomy with lymph node dissection.
- What it means: This academic programme is what the FDA approved 68Ga-PSMA-11 on in December 2020, and the Illuccix and Locametz kits rest on it for the staging indication. Its message for a man being staged before surgery is that a positive PSMA PET node is very likely real, but a negative scan does not rule out small nodal deposits, so the lymph node dissection still matters.
- Caveats: Only 36 percent of imaged men reached the surgical reference standard, so the efficacy cohort is a selected subset.; Sensitivity of 0.40 means most nodal metastases found at surgery were missed, largely because they were small.; Single-arm accuracy study; the randomised comparison with conventional imaging is proPSMA.

## Sources

- JAMA Oncology 2021: https://doi.org/10.1001/jamaoncol.2021.3771
- PubMed: https://pubmed.ncbi.nlm.nih.gov/34529005/
- ClinicalTrials.gov NCT03368547: https://clinicaltrials.gov/study/NCT03368547

## Connected records

- cancers: [Localised prostate cancer, high and very high risk](https://onco.cc/cancers/prostate-high-risk/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [PSMA PET](https://onco.cc/technologies/psma-pet/)
- targets: [PSMA](https://onco.cc/targets/psma/)
- drugs: [Gallium-68 gozetotide (PSMA-11)](https://onco.cc/drugs/ga68-psma-11/), [Illuccix (kit for Ga-68 gozetotide)](https://onco.cc/drugs/illuccix/)
- institutions: [UCLA Jonsson Comprehensive Cancer Center](https://onco.cc/institutions/ucla-jonsson/), [UCSF Helen Diller Family Comprehensive Cancer Center](https://onco.cc/institutions/ucsf/)
- trials: [PSMA-PreRP](https://onco.cc/trials/psma-prerp/)
- people: [Thomas A. Hope](https://onco.cc/people/thomas-hope/)
- journals: [JAMA Oncology](https://onco.cc/journals/jama-oncology/)

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