Effects of Initial Gleason Grade on Outcomes during Active Surveillance for Prostate Cancer

Decipher identifies men with otherwise clinically favorable-intermediate risk disease who may not be good candidates for active surveillance

“…Therefore, some institutions have expanded the inclusion criteria for AS to carefully selected "intermediate-risk" prostate cancer patients to avoid potential overtreatment. However, observational data have shown that these men clearly are at higher risk for upgrading, adverse pathology and progression to metastatic disease [8,26,27]-findings that we partly confirmed in our analysis. Patel et al [10].…”

“…The prognostic value of such [9]. Conversely, patients with F-IR tumors demonstrate favorable survival rates and thus may qualify for AS according to NCCN guidelines [8,9]. However, substantial heterogeneity still prevails within the F-IR category.…”

“…The latter parameter was an arbitrary addition that makes clinical sense but has never been validated to be an optimal threshold, and in fact no other NCCN stratum uses percent of cores involved. Studies have shown that men with F-IR PCa have similar survival outcomes compared to low-risk (LR) PCa patients, suggesting that some of these men may be appropriate candidates for active surveillance (AS) [8]. Conversely, patients with unfavorable intermediate-risk features demonstrate prostate cancer-specific and all-cause mortality rates similar to men with high-risk PCa [9].…”

Prospective evaluation of fexapotide triflutate injection treatment of Grade Group 1 prostate cancer: 4-year results

“…33% of AS group) with two biopsies which were negative but who were excluded from analysis due to early patient withdrawal, and would have qualified as negative under a different criterion of ≥ 2 biopsies negative. Progression to Gleason ≥ 4 + 3 in the AS group in this study (15.4% at 3 years, biopsy data; 8.7% if all subjects with ≥ 2 biopsies are included) was not appreciably higher than the published literature [44][45][46][47][48][49] which supports that the AS group was representative. A post hoc sensitivity test showed AS progression values in this study are comparable to published AS values if all randomized subjects in all groups with ≥ 2 biopsies are included (Table 3c, d): AS 25.9% and 34.6% at 18 and 36 months, compared to FT 15 mg 6.5% (p = 0.0199) and 11.8% (p = 0.033), and compared to pooled FT 9.7% (p = 0.0288) and 15.5% (p = 0.0392).…”

“…Larger single-center studies of AS cohorts have reported histological progression rates in the 12-51% range after median times of 1.5-6.4 years, most commonly in the 25-35% range largely depending upon criteria and methodology [44][45][46][47][48][49][50][51][52][53][54][55], and these percentages are lower than the calculated values for the AS control group in the present study. The former are based on AS protocols (which have evolved over time) and the published rates have varied depending on whether there was repeat biopsy at baseline (repeat biopsies may exclude subjects with higher baseline Gleason missed on initial biopsy); frequency of biopsies; baseline population characteristics; extent of sampling, and other factors [44][45][46][47][48][49]. The present study was designed to test treatment effect and (1) did not entail a repeat biopsy prior to enrollment, (2) there were higher core numbers per biopsy (16-core compared to usually 8-12 in the large series), (3) there were more frequent biopsies (5 biopsies by 5-year time compared to the more usual ≥ 2 biopsies in the AS protocols, (4) the study had smaller n (not comparable to major AS studies), and (5) included RP surgical pathology results in all patients where this was available after randomization.…”