The cell cycle progression test has a significant impact in assisting physicians and patients reach personalized treatment decisions.
Background:Currently, there are multiple commercially available RNA-based biomarkers that are Medicare approved and suggested for use by the National Comprehensive Cancer Network guidelines. There is uncertainty as to which patients benefit from genomic testing and for whom these tests should be ordered. Here, we examined the correlation patterns of Decipher assay to understand the relationship between the Decipher and patient tumor characteristics.Methods:De-identified Decipher test results (including Decipher risk scores and clinicopathologic data) from 2 342 consecutive radical prostatectomy (RP) patients tested between January and September 2015 were analyzed. For clinical testing, tumor specimen from the highest Gleason grade was sampled using a 1.5 mm tissue punch. Decipher scores were calculated based on a previously locked model. Correlations between Decipher score and clinicopathologic variables were computed using Spearman's rank correlation. Mixed-effect linear models were used to study the association of practice type and Decipher score. The significance level was 0.05 for all tests.Results:Decipher score had a positive correlation with pathologic Gleason score (PGS; r=0.37, 95% confidence interval (CI) 0.34−0.41), pathologic T-stage (r=0.31, 95% CI 0.28−0.35), CAPRA-S (r=0.32, 95% CI 0.28−0.37) and patient age (r=0.09, 95% CI 0.05-0.13). Decipher reclassified 52%, 76% and 40% of patients in CAPRA-S low-, intermediate- and high-risk groups, respectively. We detected a 28% incidence of high-risk disease through the Decipher score in pT2 patients and 7% low risk in pT3b/pT4, PGS 8−10 patients. There was no significant difference in the Decipher score between patients from community centers and those from academic centers (P=0.82).Conclusions:Although Decipher correlated with baseline tumor characteristics for over 2 000 patients, there was significant reclassification of tumor aggressiveness as compared to clinical parameters alone. Utilization of the Decipher genomic classifier can have major implications in assessment of postoperative risk that may impact physician-patient decision making and ultimately patient management.
ObjectivesTo evaluate the impact of a genomic classifier (GC) test for predicting metastasis risk after radical prostatectomy (RP) on urologists' decision-making about adjuvant treatment of patients with high-risk prostate cancer.Subjects and MethodsPatient case history was extracted from the medical records of each of the 145 patients with pT3 disease or positive surgical margins (PSMs) after RP treated by six high-volume urologists, from five community practices. GC results were available for 122 (84%) of these patients. US board-certified urologists (n = 107) were invited to provide adjuvant treatment recommendations for 10 cases randomly drawn from the pool of patient case histories. For each case, the study participants were asked to make an adjuvant therapy recommendation without (clinical variables only) and with knowledge of the GC test results. Recommendations were made without knowledge of other participants' responses and the presentation of case histories was randomised to minimise recall bias.ResultsA total of 110 patient case histories were available for review by the study participants. The median patient age was 62 years, 71% of patients had pT3 disease and 63% had PSMs. The median (range) 5-year predicted probability of metastasis by the GC test for the cohort was 3.9 (1–33)% and the GC test classified 72% of patients as having low risk for metastasis. A total of 51 urologists consented to the study and provided 530 adjuvant treatment recommendations without, and 530 with knowledge of the GC test results. Study participants performed a mean of 130 RPs/year and 55% were from community-based practices. Without GC test result knowledge, observation was recommended for 57% (n = 303), adjuvant radiation therapy (ART) for 36% (n = 193) and other treatments for 7% (n = 34) of patients. Overall, 31% (95% CI: 27–35%) of treatment recommendations changed with knowledge of the GC test results. Of the ART recommendations without GC test result knowledge, 40% (n = 77) changed to observation (95% CI: 33–47%) with this knowledge. Of patients recommended for observation, 13% (n = 38 [95% CI: 9–17%]) were changed to ART with knowledge of the GC test result. Patients with low risk disease according to the GC test were recommended for observation 81% of the time (n = 276), while of those with high risk, 65% were recommended for treatment (n = 118; P < 0.001). Treatment intensity was strongly correlated with the GC-predicted probability of metastasis (P < 0.001) and the GC test was the dominant risk factor driving decisions in multivariable analysis (odds ratio 8.6, 95% CI: 5.3–14.3%; P < 0.001).ConclusionsKnowledge of GC test results had a direct effect on treatment strategies after surgery. Recommendations for observation increased by 20% for patients assessed by the GC test to be at low risk of metastasis, whereas recommendations for treatment increased by 16% for patients at high risk of metastasis. These results suggest that the implementation of genomic testing in clinical practice may lead to significant chan...
PurposeUrinary continence is a driver of quality of life after radical prostatectomy. The purpose of this study was to evaluate the impact of a biologic bladder neck sling on postoperative return of urinary continence after robot-assisted radical prostatectomy (RARP). Materials and MethodsThis study compared early continence in patients undergoing RARP with a sling and without a sling in a two group, 1:1, parallel, randomized controlled trial. Patients were blinded to group assignment. The primary outcome was defined as urinary continence (0-1 pads per day) at 1 month postoperative. Inclusion criteria included organ-confined prostate cancer and a prostatespecific antigen <15. Exclusion criteria included any prior surgery on the prostate, history of neurogenic bladder, and history of prior pelvic radiation. A chi-squared test was used for the primary outcome. ResultsA total of 147 patients were randomized (control=74, sling=73), and 92% were available for primary endpoint analysis at 1 month. There were no significant differences in baseline or perioperative data except that operating room time was 20.1 minutes longer for the sling group (P=0.04). The continence rate was similar between control and sling groups at both 1 month (47.1% vs. 55.2%, P=0.34) and 12 months (86.7% vs. 94.5%, P=0.15), respectively. Adverse events were similar between control and sling groups (10.8% vs. 13.7%, P=0.59). 3 ConclusionsThe application of an absorbable urethral sling at the time of RARP was well tolerated with no increase in obstructive symptoms in this randomized trial. However, the sling failed to show a significant improvement in continence.4
Information on individualized metastasis risk based on a patient's tumor biology, with use of the GC test, significantly changed urologists' adjuvant treatment recommendations for post-operative patients with prostate cancer, who were at high risk of metastasis. Namely, the results of this study provide evidence for the utility of the GC test, and show it may guide use of adjuvant radiation.
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