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    European urology oncology. 2019 Dec 3. pii: S2588-9311(19)30162-2. doi: 10.1016/j.euo.2019.11.003
    Defining the Most Informative Intermediate Clinical Endpoints for Patients Treated with Salvage Radiotherapy for Prostate-specific Antigen Rise After Radical Prostatectomy.
    Martini A1,  Fossati N2,  Karnes RJ3,  Boorjian SA4,  Boeri L5,  Bossi A6,  Di Muzio N7,  Cozzarini C8,  Noris Chiorda B9,  Gandaglia G10,  Robesti D11,  Bartkowiak D12,  Böhmer D13,  Shariat SF14,  Goldner G15,  Battaglia A16,  Joniau S17,  Berghen C18,  De Meerleer G19,  Fonteyne V20,  Ost P21,  Van Poppel H22,  Montorsi F23,  Wiegel T24,  Briganti A25
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    Abstract

    Intermediate clinical endpoints (ICEs) might aid in trial design and potentially expedite study results. However, little is known about the most informative ICE for patients receiving salvage radiation therapy (sRT) after radical prostatectomy. To investigate the most informative ICE for patients receiving sRT, we used a multi-institutional database encompassing patients treated at eight tertiary centers. Overall, 1301 men with node-negative disease who had not received any form of androgen deprivation therapy were identified. Associations of biochemical (BCR) and clinical recurrence (CR) within 1, 3, 5, and 7yr after surgery with the risk of overall mortality were evaluated using multivariable Cox regression analyses fitted at the landmark points of 1, 3, 5, and 7yr after sRT. The discriminative ability of each model for predicting overall survival (OS) was assessed using Harrell's c index. Median follow-up for survivors was 5.6yr (interquartile range 2.0-8.8). On multivariable analysis, progression to CR within 3yr from sRT (hazard ratio 4.19, 95% confidence interval 1.44-11.2; p= 0.008) was the most informative ICE for predicting OS (c index 0.78) compared to CR within 1, 5, and 7yr (c index 0.72, 0.75, and 0.71). In conclusion, progression to CR within 3yr after sRT, irrespective of the time of surgery, was the most informative ICE for prediction of OS. Our study is hypothesis-generating. If these results are confirmed in future prospective studies and surrogacy is met, this information could be applied for study design and could potentially expedite earlier release of results from ongoing randomized controlled trials. PATIENT SUMMARY: Clinical recurrence of prostate cancer within 3yr after salvage radiation therapy, irrespective of the time of radical prostatectomy, represents the most informative intermediate clinical endpoint for the prediction of overall survival. This information could be applied in the design of future studies and could potentially expedite earlier release of results from ongoing randomized controlled trials.


    Copyright © 2019 European Association of Urology. All rights reserved.

    KEYWORDS: Biochemical recurrence, Intermediate clinical endpoints, Metastasis, Prostate cancer, Salvage radiation therapy

    Publikations ID: 31810893
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