Presurgical 68Ga-PSMA-11 Positron Emission Tomography for Biochemical Recurrence Risk Assessment: A Follow-up Analysis of a Multicenter Prospective Phase 3 Imaging Trial.

Djaïleb, Loïc; Armstrong, Wesley R; Thompson, Daniel; Gafita, Andrei; Farolfi, Andrea; Rajagopal, Abhejit; Grogan, Tristan R; Nguyen, Kathleen; Benz, Matthias R; Hotta, Masatoshi; Barbato, Francesco; Ceci, Francesco; Schwarzenböck, Sarah M; Unterrainer, Marcus; Zacho, Helle D; Juarez, Roxanna; Cooperberg, Matthew; Carroll, Peter; Washington, Samuel; Reiter, Robert E; Eiber, Matthias; Herrmann, Ken; Fendler, Wolfgang P; Czernin, Johannes; Hope, Thomas A; Calais, Jeremie

doi:10.1016/j.eururo.2023.06.022

Benutzer: Gast

2023

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Dokumenttyp:: Clinical Trial, Phase III; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
Autor(en):: Djaïleb, Loïc; Armstrong, Wesley R; Thompson, Daniel; Gafita, Andrei; Farolfi, Andrea; Rajagopal, Abhejit; Grogan, Tristan R; Nguyen, Kathleen; Benz, Matthias R; Hotta, Masatoshi; Barbato, Francesco; Ceci, Francesco; Schwarzenböck, Sarah M; Unterrainer, Marcus; Zacho, Helle D; Juarez, Roxanna; Cooperberg, Matthew; Carroll, Peter; Washington, Samuel; Reiter, Robert E; Eiber, Matthias; Herrmann, Ken; Fendler, Wolfgang P; Czernin, Johannes; Hope, Thomas A; Calais, Jeremie
Titel:: Presurgical 68Ga-PSMA-11 Positron Emission Tomography for Biochemical Recurrence Risk Assessment: A Follow-up Analysis of a Multicenter Prospective Phase 3 Imaging Trial.
Abstract:: BACKGROUND: In the initial staging of patients with high-risk prostate cancer (PCa), prostate-specific membrane antigen positron emission tomography (PSMA-PET) has been established as a front-line imaging modality. The increasing number of PSMA-PET scans performed in the primary staging setting might be associated with decreases in biochemical recurrence (BCR)-free survival (BCR-FS). OBJECTIVE: To assess the added prognostic value of presurgical PSMA-PET for BCR-FS compared with the presurgical Cancer of the Prostate Risk Assessment (CAPRA) and postsurgical CAPRA-Surgery (CAPRA-S) scores in patients with intermediate- to high-risk PCa treated with radical prostatectomy (RP) and pelvic lymph node dissection. DESIGN, SETTING, AND PARTICIPANTS: This is a follow-up study of the surgical cohort evaluated in the multicenter prospective phase 3 imaging trial (n = 277; NCT03368547, NCT02611882, and NCT02919111). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Each 68Ga-PSMA-11-PET scan was read by three blinded independent readers. PSMA-PET prostate uptake (low vs high), PSMA-PET extraprostatic disease (N1/M1), and CAPRA and CAPRA-S scores were used to assess the risk of BCR. Patients were followed after RP by local investigators using electronic medical records. BCR was defined by a prostate-specific antigen (PSA) level increasing to ≥0.2 ng/ml after RP or initiation of PCa-specific secondary treatment (>6 mo after surgery). Univariate and multivariable Cox models, and c-statistic index were performed to assess the prognostic value of PSMA-PET and for a comparison with the CAPRA and CAPRA-S scores. RESULTS AND LIMITATIONS: From December 2015 to December 2019, 277 patients underwent surgery after PSMA-PET. Clinical follow-up was obtained in 240/277 (87%) patients. The median follow-up after surgery was 32.4 (interquartile range 23.3-42.9) mo. Of 240 BCR events, 91 (38%) were observed. PSMA-PET N1/M1 was found in 41/240 (17%) patients. PSMA-PET prostate uptake, PSMA-PET N1/M1, and CAPRA and CAPRA-S scores were significant univariate predictors of BCR. The addition of PSMA-PET N1/M1 status to the presurgical CAPRA score improved the risk assessment for BCR significantly in comparison with the presurgical CAPRA score alone (c-statistic 0.70 [0.64-0.75] vs 0.63 [0.57-0.69]; p < 0.001). The C-index of the postsurgical model utilizing the postsurgical CAPRA-S score alone was not significantly different from the presurgical model combining the presurgical CAPRA score and PSMA-PET N1/M1 status (p = 0.19). CONCLUSIONS: Presurgical PSMA-PET was a strong prognostic biomarker improving BCR-FS risk assessment. Its implementation in the presurgical risk assessment with the CAPRA score improved the performance and reduced the difference with the reference standard (postsurgical CAPRA-S score). PATIENT SUMMARY: The use prostate-specific membrane antigen positron emission tomography improved the assessment of biochemical recurrence risk in patients with intermediate- and high-risk prostate cancer who were treated with radical prostatectomy and pelvic lymph node dissection.
Zeitschriftentitel:: Eur Urol
Jahr:: 2023
Band / Volume:: 84
Heft / Issue:: 6
Seitenangaben Beitrag:: 588-596
Volltext / DOI:: doi:10.1016/j.eururo.2023.06.022
PubMed:: http://view.ncbi.nlm.nih.gov/pubmed/37482512
Print-ISSN:: 0302-2838
TUM Einrichtung:: 1413; 595; Klinik und Poliklinik für Nuklearmedizin (Prof. Weber)
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mediaTUM Gesamtbestand Einrichtungen Schools TUM School of Medicine and Health Departments Clinical Medicine Klinik und Poliklinik für Nuklearmedizin (Prof. Weber)2023

mediaTUM Gesamtbestand Einrichtungen Schools TUM School of Medicine and Health Departments