Assessment of <sup>68</sup>Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer

Wolfgang P. Fendler(University of Duisburg-Essen), Jérémie Calais(University of California, Los Angeles), Matthias Eiber(Klinikum rechts der Isar), Robert R. Flavell(University of California, San Francisco), Ashley Mishoe(University of California, San Francisco), Felix Y. Feng(University of California, San Francisco), Hao G. Nguyen(University of California, San Francisco), Robert E. Reiter(UCLA Medical Center), Matthew B. Rettig(Ronald Reagan UCLA Medical Center), Shozo Okamoto(Hokkaido University), Louise Emmett(St Vincent's Hospital Sydney), Helle D. Zacho(Aalborg University Hospital), Harun Ilhan(Ludwig-Maximilians-Universität München), Axel Wetter(University of Duisburg-Essen), Christoph Rischpler(University of Duisburg-Essen), Heiko Schöder(Memorial Sloan Kettering Cancer Center), Irene A. Burger(University Hospital of Zurich), J Gartmann(University of California, Los Angeles), Raven Smith(University of California, San Francisco), Eric J. Small(University of California, San Francisco), Roger Slavik(University of California, Los Angeles), Peter R. Carroll(University of California, San Francisco), Ken Herrmann(University of California, Los Angeles), Johannes Czernin(University of California, Los Angeles), Thomas A. Hope(University of California, San Francisco)
JAMA Oncology
March 28, 2019
10.1001/jamaoncol.2019.0096
Cited by 782Open Access
Full Text

Abstract

IMPORTANCE: In retrospective studies, 68Ga-PSMA-11 positron emission tomographic (PET) imaging improves detection of biochemically recurrent prostate cancer compared with conventional imaging. OBJECTIVE: To assess 68Ga-PSMA-11 PET accuracy in a prospective multicenter trial. DESIGN, SETTING, AND PARTICIPANTS: In this single-arm prospective trial conducted at University of California, San Francisco and University of California, Los Angeles, 635 patients with biochemically recurrent prostate cancer after prostatectomy (n = 262, 41%), radiation therapy (n = 169, 27%), or both (n = 204, 32%) underwent 68Ga-PSMA-11 PET. Presence of prostate cancer was recorded by 3 blinded readers on a per-patient and per-region base. Lesions were validated by histopathologic analysis and a composite reference standard. MAIN OUTCOMES AND MEASURES: Endpoints were positive predictive value (PPV), detection rate, interreader reproducibility, and safety. RESULTS: A total of 635 men were enrolled with a median age of 69 years (range, 44-95 years). On a per-patient basis, PPV was 0.84 (95% CI, 0.75-0.90) by histopathologic validation (primary endpoint, n = 87) and 0.92 (95% CI, 0.88-0.95) by the composite reference standard (n = 217). 68Ga-PSMA-11 PET localized recurrent prostate cancer in 475 of 635 (75%) patients; detection rates significantly increased with prostate-specific antigen (PSA): 38% for <0.5 ng/mL (n = 136), 57% for 0.5 to <1.0 ng/mL (n = 79), 84% for 1.0 to <2.0 ng/mL (n = 89), 86% for 2.0 to <5.0 ng/mL (n = 158), and 97% for ≥5.0 ng/mL (n = 173, P < .001). Interreader reproducibility was substantial (Fleiss κ, 0.65-0.78). There were no serious adverse events associated with 68Ga-PSMA-11 administration. PET-directed focal therapy alone led to a PSA drop of 50% or more in 31 of 39 (80%) patients. CONCLUSIONS AND RELEVANCE: Using blinded reads and independent lesion validation, we establish high PPV for 68Ga-PSMA-11 PET, detection rate and interreader agreement for localization of recurrent prostate cancer. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT02940262 and NCT03353740.

Related Papers

No related papers found

Powered by citation graph analysis