A 12-year follow-up of ANNA/C-TRUS image-targeted biopsies in patients suspicious for prostate cancer

Objective: The aim of this study was to examine elastography-based prostate biopsy in prostate cancer (PCa) patients under active surveillance. Patients and Methods: We relied on PCa patients who opted for active surveillance and underwent elastography targeted and systematic follow-up biopsy at the Braunschweig Prostate Cancer Center between October 2009 and February 2015. Each prostate sextant was considered as an individual case. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy (ACC) for elastography to predict follow-up biopsy results were analyzed, respectively, and 95 % confidence intervals (CIs) were carried out by using 2000 bootstrapping sample analyses. Results: Overall, 50 men and 300 sextants were identified. Overall, 27 (54%) men and 66 (22%) sextants harbored PCa at follow-up biopsy. Sensitivity, specificity, PPV, NPV, and ACC for elastography to predict follow-up biopsy results were: 19.7 (95% CI: 11.9–27.3), 86.8 (95% CI: 82.7–90.3), 29.6 (95% CI: 14.6–46.0), 79.3 (95% CI: 71.6–86.5), and 72.0% (95% CI: 65.7–78.3), respectively. Conclusions: We recorded limited reliability of elastography-based prediction of follow-up biopsy results in active surveillance patients. Based on our analyses, we can neither recommend to rely exclusively on elastography-based targeted biopsies nor to delay or to omit follow-up biopsies based on elastography results during active surveillance.

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Incorporating mpMRI and biomarkers in active surveillance protocols: The prospective Stockholm3 Active Surveillance trial (STHLM3AS).

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.6_suppl.tps379 ◽

2020 ◽

Vol 38 (6_suppl) ◽

pp. TPS379-TPS379

Author(s):

Anna Lantz ◽

Henrik Olsson ◽

Tobias Nordström ◽

Fredrik Jäderling ◽

Lars Egevad ◽

...

Keyword(s):

Prostate Cancer ◽

Active Surveillance ◽

Cancer Progression ◽

Multicenter Study ◽

Prediction Models ◽

Background Level ◽

National Guidelines ◽

Prospective Multicenter Study ◽

Targeted Biopsies

TPS379 Background: Level one evidence shows that men with low-risk prostate cancer undergoing active surveillance (AS) with repeated PSA tests and systematic biopsies have low mortality. However, monitoring sometimes misses significant cancer progression and causes patient morbidity. The objective of this study is to evaluate a new proposed protocol for AS using the combination of the Stockholm3 test and MRI targeted biopsies in comparison to conventional follow-up using PSA and systematic biopsies. Methods: A prospective multicenter study with paired design was used to evaluate our proposed protocol (Stockholm3, MRI, targeted biopsies) compared with the conventional protocol according to Swedish National Guidelines (PSA, systematic biopsies) for follow-up of men on AS. The STHLM3 study was performed between 2012-2014. In the study 1 374 men were diagnosed with ISUP grade 1 disease. Out of these, 541 men currently on AS were invited to the STHLM3AS study. Eligible individuals had to be alive without any severe comorbidity, without contraindications for MRI and without a history of initiating prostate cancer treatment. The primary endpoint ISUP grade ≥2 cancer and the secondary endpoint number of performed biopsies will be evaluated using relative sensitivity (RS). At baseline a blood test for PSA and Stockholm3 test as well as a bi-parametric MRI was performed. For men with PIRADS ≥ 3 targeted and systematic biopsies were performed. For men with PIRADS < 3 only systematic biopsies were performed. The study is registered at ClinicalTrials.gov (NCTNCT03956108). Results: 301 men on AS have been included in the study. Since this is a trial in progress, no results will be presented. Conclusions: To our knowledge, this is the largest prospective multicenter study evaluating the performance of MRI for disease monitoring in an AS-cohort. Prediction models using biomarkers and MRI will likely both have an increasing role in the monitoring of AS patients in the future. We hypothesise that the sequential use of first Stockholm3 test followed by MRI will decrease the number of biopsies, while retaining the sensitivity to detect ISUP grade ≥2 cancer compared with using systematic biopsies in all men. Clinical trial information: NCTNCT03956108.

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