Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer: A Prospective Single-Arm Clinical Trial

Wolfgang P. Fendler, Jeremie Calais, Matthias Eiber, Robert R. Flavell, Ashley Mishoe, Felix Y. Feng, Hao G. Nguyen, Robert E. Reiter, Matthew B. Rettig, Shozo Okamoto, Louise Emmett, Helle D. Zacho, Harun Ilhan, Axel Wetter, Christoph Rischpler, Heiko Schoder, Irene A. Burger, Jeannine Gartmann, Raven Smith, Eric J. SmallRoger Slavik, Peter R. Carroll, Ken Herrmann, Johannes Czernin, Thomas A. Hope

Research output: Contribution to journalArticlepeer-review

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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: identifiers: NCT02940262 and NCT03353740.

Original languageEnglish
Pages (from-to)856-863
Number of pages8
JournalJAMA Oncology
Issue number6
StatePublished - Jun 2019
Externally publishedYes


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