Compliance Rates with the XXXX Research International Active Surveillance (PRIAS) Protocol and Disease Reclassification in Noncompliers.

@entity1 @entity263 @entity5 @entity3457 @entity1486
BACKGROUND: @entity1 with @entity263 on @entity3457 ( @entity3457 ) are advised to follow strict follow-up schedules and switch to definitive treatment on risk reclassification. However, some @entity1 might not adhere to these strict protocols. OBJECTIVE: To determine the number of noncompliers and disease reclassification rates in @entity1 not complying with the follow-up protocol of the @entity263 Research International Active Surveillance (PRIAS) study. DESIGN, SETTING, AND @entity1 : A total of 4547 @entity1 with @entity263 were included and prospectively followed on @entity3457 . @entity1 were regularly examined using @entity1486 , digital rectal examination, and repeat biopsies, and were advised to switch to definitive treatment on disease reclassification (>cT2c, Gleason score > 3+3, >2 cores positive, or @entity1486 doubling time [ @entity1486 -DT] 0-3 yr). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Rates of @entity1 not complying with follow-up visits or a recommendation to discontinue @entity3457 are reported. Biopsy outcome (Gleason >= 7 or >2 cores positive) was compared between compliers and noncompliers using Cox proportional hazards analysis. RESULTS AND LIMITATIONS: The compliance rate for @entity1486 visits was 91%. By contrast, the compliance rate for standard repeat biopsies decreased over time (81%, 60%, 53%, and 33% at 1, 4, 7, and 10 yr after diagnosis, respectively). Yearly repeat biopsies in @entity1 with faster rising @entity1486 ( @entity1486 -DT 3-10 yr) was low at <30%, although these @entity1 had higher upgrading rates at repeat biopsy (25-30% vs 16%). @entity1486 -DT of 0-3 yr was the most common recommendation for discontinuation, but 71% continued on @entity3457 . @entity1 with @entity1486 -DT of 0-3 yr were at higher risk of upgrading on repeat biopsy (hazard ratio 2.02, 95% confidence interval 1.36-3.00) compared to @entity1 without fast rising @entity1486 . CONCLUSION: Some @entity1 and their physicians do not comply with @entity3457 follow-up protocols. In particular, yearly repeat biopsies in @entity1 with fast rising @entity1486 are often ignored, as is the recommendation to discontinue @entity3457 because of very fast rising @entity1486 . Although these @entity1 are at greater risk of higher Gleason scores on repeat biopsy, the majority still exhibit favorable @entity5 characteristics. Fast rising @entity1486 should therefore not trigger a recommendation to receive active treatment, but should rather serve as a criterion for stricter follow-up. In addition, we should aim to find ways of safely reducing the number of biopsies to increase adherence to @entity3457 protocols. @entity1 SUMMARY: We looked at compliance with an @entity3457 protocol for @entity263 in a large @entity3457 study. We observed reluctance to undergo yearly biopsies because of fast rising @entity1486 , despite a higher risk of disease progression. Further research should aim to safely reduce the number of repeat biopsies in @entity1 on @entity3457 to increase protocol adherence.
