# Accuracy of gallium-68 PSMA-11 PET in localising recurrent prostate cancer: a prospective single-arm clinical trial

Source: https://onco.cc/key-papers/paper-fendler-psma-pet-biochemical-recurrence-jama-oncol-2019/  
OnCo record `paper-fendler-psma-pet-biochemical-recurrence-jama-oncol-2019` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

In 635 men whose PSA had started rising again, a PSMA scan found where the cancer was in three quarters of them, and the chance of finding it rose steeply with the PSA level.

## Summary

In a single-arm prospective trial at two universities, 635 men with biochemically recurrent prostate cancer after prostatectomy (262, 41%), radiation therapy (169, 27%) or both (204, 32%) underwent gallium-68 PSMA-11 PET, with the presence of prostate cancer recorded by three blinded readers on a per-patient and per-region basis and lesions validated by histopathology and by a composite reference standard. Median age was 69 years. Positive predictive value was 0.84 by histopathological validation in 87 men and 0.92 by the composite reference standard in 217 men. The scan localised recurrent prostate cancer in 475 of 635 men, 75%, and detection rates rose significantly with PSA: 38% below 0.5 ng/mL in 136 men, 57% at 0.5 to under 1.0 in 79, 84% at 1.0 to under 2.0 in 89, 86% at 2.0 to under 5.0 in 158 and 97% at 5.0 or above in 173. Interreader reproducibility was substantial, Fleiss kappa 0.65 to 0.78, and there were no serious adverse events. PET-directed focal therapy alone led to a PSA drop of 50% or more in 31 of 39 men, 80%.

## Fields

- Kind: Key paper
- Last checked: 2026-09-25
- Journal: JAMA Oncology
- Year: 2019
- DOI: 10.1001/jamaoncol.2019.0096
- Authors: Fendler WP, Calais J, Eiber M, et al.
- Findings: Recurrence localised in 475 of 635 men, 75%.; Detection rate 38% below PSA 0.5 ng/mL, rising to 97% at 5.0 or above.; Positive predictive value 0.84 by histopathology and 0.92 by composite reference standard.; PSA fall of at least half in 31 of 39 men treated with PET-directed focal therapy alone.
- What it means: It is the evidence behind using PSMA PET when PSA rises after treatment, and it quantifies the limit that matters most: below PSA 0.5 ng/mL, where salvage radiotherapy works best, the scan is negative in nearly two men in three, so a negative scan is not a reason to wait.
- Caveats: Two academic centres with experienced readers, so performance elsewhere may be lower.; Histopathological validation was available for only 87 of 635 men.; The PSA responses to focal therapy show the scan pointed at real disease, not that focal therapy cures.

## Sources

- Fendler et al., JAMA Oncol 2019: prospective accuracy of gallium-68 PSMA-11 PET in 635 men with biochemically recurrent prostate cancer: https://doi.org/10.1001/jamaoncol.2019.0096
- PubMed: https://pubmed.ncbi.nlm.nih.gov/30920593/

## Connected records

- cancers: [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [PET/CT](https://onco.cc/technologies/pet-ct/), [PSMA PET](https://onco.cc/technologies/psma-pet/)
- targets: [PSMA](https://onco.cc/targets/psma/)
- pathways: [Prostate cancer (KEGG map)](https://onco.cc/pathways/prostate-cancer-signalling/)
- terms: [Biochemical recurrence (BCR)](https://onco.cc/terms/biochemical-recurrence/), [PSA (prostate-specific antigen)](https://onco.cc/terms/psa/), [Theranostics](https://onco.cc/terms/theranostics/)
- journals: [JAMA Oncology](https://onco.cc/journals/jama-oncology/)
- biomarkers: [PSMA expression by PET (PSMA-positive)](https://onco.cc/biomarkers/psma-pet-expression/)

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