The DOI matches its Crossref record; 3 of the 3 references it cites were found in a registry or an index.
Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer: A Prospective Single-Arm Clinical Trial
Open accessAbstract
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.
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The Measurement of Observer Agreement for Categorical Data
Landis, J. R., & Koch, G. G. (1977) · Biometrics · doi:10.2307/2529310 · Cited by 81,148
68Ga-PSMA PET/CT: Joint EANM and SNMMI procedure guideline for prostate cancer imaging: version 1.0
Fendler, W. P., Eiber, M., Beheshti, M., Bomanji, J., Ceci, F., Cho, S., Giesel, F., Haberkorn, U., Hope, T. A., Kopka, K., et al. (2017) · European Journal of Nuclear Medicine and Molecular Imaging · doi:10.1007/s00259-017-3670-z · Cited by 750
Self-citationEiber, M., Herrmann, K., Calais, J., Hadaschik, B., Giesel, F. L., Hartenbach, M., Hope, T., Reiter, R., Maurer, T., Weber, W. A., et al. (2018) · Journal of Nuclear Medicine · doi:10.2967/jnumed.117.198119 · Cited by 626
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Morris, M. J., Rowe, S. P., Gorin, M. A., Saperstein, L., Pouliot, F., Josephson, D., Wong, J. Y. C., Pantel, A. R., Cho, S. Y., Gage, K. L., et al. (2021) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-20-4573 · Cited by 389
Self-citationE-PSMA: the EANM standardized reporting guidelines v1.0 for PSMA-PET
Ceci, F., Oprea-Lager, D. E., Emmett, L., Adam, J. A., Bomanji, J., Czernin, J., Eiber, M., Haberkorn, U., Hofman, M. S., Hope, T. A., et al. (2021) · European Journal of Nuclear Medicine and Molecular Imaging · doi:10.1007/s00259-021-05245-y · Cited by 368
Self-citationHope, T. A., Eiber, M., Armstrong, W. R., Juarez, R., Murthy, V., Lawhn-Heath, C., Behr, S. C., Zhang, L., Barbato, F., Ceci, F., et al. (2021) · JAMA Oncology · doi:10.1001/jamaoncol.2021.3771 · Cited by 357
Self-citationFendler, W. P., Weber, M., Iravani, A., Hofman, M. S., Calais, J., Czernin, J., Ilhan, H., Saad, F., Small, E. J., Smith, M. R., et al. (2019) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-19-1050 · Cited by 266
Self-citationHummel, H.-D., Kufer, P., Grüllich, C., Seggewiss-Bernhardt, R., Deschler-Baier, B., Chatterjee, M., Goebeler, M.-E., Miller, K., de Santis, M., Loidl, W., et al. (2021) · Immunotherapy · doi:10.2217/imt-2020-0256 · Cited by 154
Metadata
- Authors
- Fendler, W. P., Calais, J., Eiber, M., Flavell, R. R., Mishoe, A., Feng, F. Y., Nguyen, H. G., Reiter, R. E., Rettig, M. B., Okamoto, S., Emmett, L., Zacho, H. D., Ilhan, H., Wetter, A., Rischpler, C., Schoder, H., Burger, I. A., Gartmann, J., Smith, R., Small, E. J., Slavik, R., Carroll, P. R., Herrmann, K., Czernin, J., & Hope, T. A.
- Venue
- JAMA Oncology
- Publisher
- American Medical Association (AMA)
- Published
- 2019-06-01
- Volume
- 5
- Issue
- 6
- Pages
- 856
- ISSN
- 2374-2437 (ISSN-L)
- OpenAlex
- W2924617625
- Cited by
- 779
- References
- 3
- FWCI
- 61.77
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Fendler, W. P., Calais, J., Eiber, M., Flavell, R. R., Mishoe, A., Feng, F. Y., Nguyen, H. G., Reiter, R. E., Rettig, M. B., Okamoto, S., Emmett, L., Zacho, H. D., Ilhan, H., Wetter, A., Rischpler, C., Schoder, H., Burger, I. A., Gartmann, J., Smith, R., . . . Hope, T. A. (2019). Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer: A Prospective Single-Arm Clinical Trial. JAMA Oncology. https://doi.org/10.1001/jamaoncol.2019.0096
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