TY - JOUR
T1 - Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer
T2 - A Prospective Single-Arm Clinical Trial
AU - Fendler, Wolfgang P
AU - Calais, Jeremie
AU - Eiber, Matthias
AU - Flavell, Robert R
AU - Mishoe, Ashley
AU - Feng, Felix Y
AU - Nguyen, Hao G
AU - Reiter, Robert E
AU - Rettig, Matthew B
AU - Okamoto, Shozo
AU - Emmett, Louise
AU - Zacho, Helle D
AU - Ilhan, Harun
AU - Wetter, Axel
AU - Rischpler, Christoph
AU - Schoder, Heiko
AU - Burger, Irene A
AU - Gartmann, Jeannine
AU - Smith, Raven
AU - Small, Eric J
AU - Slavik, Roger
AU - Carroll, Peter R
AU - Herrmann, Ken
AU - Czernin, Johannes
AU - Hope, Thomas A
PY - 2019/6/1
Y1 - 2019/6/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85063570129&partnerID=8YFLogxK
U2 - 10.1001/jamaoncol.2019.0096
DO - 10.1001/jamaoncol.2019.0096
M3 - Journal article
C2 - 30920593
SN - 2374-2437
VL - 5
SP - 856
EP - 863
JO - JAMA Oncology
JF - JAMA Oncology
IS - 6
ER -