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No AccessJournal of UrologyAdult Urology1 Apr 2020

Prostate Specific Antigen Criteria to Diagnose Failure of Cancer Control following Focal Therapy of Nonmetastatic Prostate Cancer Using High Intensity Focused Ultrasound

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    Purpose:

    We determined whether prostate specific antigen criteria after focal high intensity focused ultrasound to treat prostate cancer could diagnose treatment failure.

    Materials and Methods:

    A total of 598 patients in a prospectively maintained national database underwent focal high intensity focused ultrasound with a Sonablate® 500 device from March 2007 to November 2016. Followup consisted of 3-month clinic visits and prostate specific antigen testing in year 1 with prostate specific antigen measurement every 6 to 12 months and multiparametric magnetic resonance imaging with biopsy for magnetic resonance imaging suspicious for recurrence. Treatment failure was considered any secondary treatment, tumor recurrence with Gleason 3 + 4 or greater disease on prostate biopsy without further treatment or metastasis and/or prostate cancer related mortality. To diagnose failure we evaluated a series of nadir + x thresholds with x values of 0.1 to 2.0 ng/ml.

    Results:

    Median patient age was 65 years (IQR 60–71) and the median Gleason score was 7 (range 6-9). Gleason 3 + 4 or greater disease was present in 80% of cases. Tumors were radiologically staged as T1c-T2c in 522 of the 596 patients (88%) and as T3a/b in 74 (12.4%). Baseline median prostate specific antigen was 7.80 ng/ml (IQR 5.96–10.45) in failed cases and 6.77 ng/ml (IQR 2.65–9.71) in cases without failure. Optimal performance according to the Youden index to indicate the most appropriate nadir + x at all analyzed time points at 3-month intervals showed that nadir + 1.0 ng/ml would have 27.3% to 100% sensitivity and 39.4% to 85.6% specificity depending on the time of evaluation in the first 3 years. Nadir + 1.5 ng/ml showed 18.2% to 100% sensitivity and 60.6% to 91.8% specificity with nadir + 2.0 ng/ml leading to similar sensitivity and specificity ranges. Nadir + 1.0 ng/ml at 12 months and nadir + 1.5 ng/ml at 24 and 36 months had 100% sensitivity and 96.1% to 100% negative predictive value.

    Conclusions:

    Following focal high intensity focused ultrasound a prostate specific antigen nadir of 1.0 ng/ml at 12 months and 1.5 ng/ml at 24 to 36 months might be used to triage men requiring magnetic resonance imaging and biopsy. These data need prospective validation.

    References

    • 1. : The role of focal therapy in the management of localised prostate cancer: a systematic review. Eur Urol 2014; 66: 732. Google Scholar
    • 2. : Focal therapy for localised unifocal and multifocal prostate cancer: a prospective development study. Lancet Oncol 2012; 13: 622. Google Scholar
    • 3. : Focal ablation targeted to the index lesion in multifocal localised prostate cancer: a prospective development study. Eur Urol 2015; 68: 927. Google Scholar
    • 4. : Focal therapy: patients, interventions, and outcomes—a report from a consensus meeting. Eur Urol 2015; 67: 771. Google Scholar
    • 5. : A multicentre study of 5-year outcomes following focal therapy in treating clinically significant nonmetastatic prostate cancer. Eur Urol 2018; 74: 422. Google Scholar
    • 6. : Standardization of definitions in focal therapy of prostate cancer: report from a Delphi consensus project. World J Urol 2016; 34: 1373. Google Scholar
    • 7. : Focal therapy in prostate cancer: international multidisciplinary consensus on trial design. Eur Urol 2014; 65: 1078. Google Scholar
    • 8. : EAU-ESTRO-SIOG guidelines on prostate cancer. Part II: treatment of relapsing, metastatic, and castration-resistant prostate cancer. Eur Urol 2017; 71: 630. Google Scholar
    • 9. : Clinically localized prostate cancer: AUA/ASTRO/SUO guideline. Part I: risk stratification, shared decision making, and care options. J Urol 2018; 199: 683. LinkGoogle Scholar
    • 10. : Focal therapy in prostate cancer: determinants of success and failure. J Endourol 2010; 24: 819. Google Scholar
    • 11. : Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ 2008; 337: a1655. Google Scholar
    • 12. : IDEAL framework for surgical innovation 2: observational studies in the exploration and assessment stages. BMJ 2013; 346: f3011. Google Scholar
    • 13. : Medium-term outcomes after whole-gland high-intensity focused ultrasound for the treatment of nonmetastatic prostate cancer from a multicentre registry cohort. Eur Urol 2016; 70: 668. Google Scholar
    • 14. : Prostate-specific antigen vs. magnetic resonance imaging parameters for assessing oncological outcomes after high intensity-focused ultrasound focal therapy for localized prostate cancer. Urol Oncol 2017; 35: 30.e9. Google Scholar
    • 15. ICECaP Working Group: The development of Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP). J Natl Cancer Inst 2015; 107: djv261. Google Scholar
    • 16. : Focal therapy for prostate cancer: rationale and treatment opportunities. Clin Oncol (R Coll Radiol) 2013; 25: 461. Google Scholar
    • 17. : Defining biochemical failure following radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer: recommendations of the RTOG-ASTRO Phoenix Consensus Conference. Int J Radiat Oncol Biol Phys 2006; 65: 965. Google Scholar
    • 18. : Histological outcomes after focal high-intensity focused ultrasound and cryotherapy. World J Urol 2015; 33: 955. Google Scholar
    • 19. : Systematic review of complications of prostate biopsy. Eur Urol 2013; 64: 876. Google Scholar
    • 20. : A multi-centre prospective development study evaluating focal therapy using high intensity focused ultrasound for localised prostate cancer: the INDEX study. Contemp Clin Trials 2013; 36: 68. Google Scholar

    Supported by the United Kingdom MRC (Medical Research Council) (HUA) and an unrestricted grant from Sonacare (ME and HUA).

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