OncologyNADiA ProsVue Prostate-specific Antigen Slope Is an Independent Prognostic Marker for Identifying Men at Reduced Risk of Clinical Recurrence of Prostate Cancer After Radical Prostatectomy
Section snippets
Study Design
The required sample size was determined to be 262, assuming a type I error rate of 5%, 80% power, and a univariate hazard ratio (HR) for a PSA slope of 1.4 (as estimated from pilot studies) using a 2-sided test. Assuming a 20% prevalence for recurrence, a minimum of 52 men with recurrence was required. A cohort random sampling of eligible men was performed within 4 strata arising from categorization of older than or younger than the median patient age (61.4 years) and median sample storage time
Study Population
The patient characteristics are listed in Table 1. For discrete covariates, category frequencies are provided, and for continuously valued covariates, the mean, median, and interquartile ranges (IQRs) are given. Overall, 56.1% of men had organ-confined disease, and 3% had evidence of nodal spread. Also, 46% had a Gleason score of ≤6 and 76.6% had a PSA value of ≤10 ng/mL at RP. Comparing the recurrent and nonrecurrent groups, the pre-RP PSA level, tumor volume, presence of stage pT3-pT4
Comment
Prostate cancer is a complex disease, and it has proved difficult to predict the clinical outcome accurately in individual men after RP.8 Previous studies have linked undetectable PSA levels of <0.01 ng/mL (<10 pg/mL) after RP to biochemical relapse-free survival12 and nadir values to a lower likelihood of BCR.14 However, the risk of BCR is not informative as a predictor of clinical endpoints because of the unpredictable kinetics of post-RP PSA values after a BCR event occurs.19, 20, 21, 22, 23
Conclusion
This is the first study of a prognostic assay for risk stratification of clinical prostate cancer recurrence with >10 years of median follow-up. NADiA ProsVue is also the first assay based on the linear slope of tumor marker concentrations over time to receive Food and Drug Administration clearance. A ProsVue result was the most powerful indicator of a reduced risk of clinical recurrence and added prognostic value to established risk factors. ProsVue testing could possibly reduce healthcare
References (26)
- et al.
Epidemiology of radical prostatectomy for localized prostate cancer in the era of prostate-specific antigen: an overview of the Department of Defense Center for Prostate Disease Research national database
Surgery
(2002) - et al.
A critical analysis of the interpretation of biochemical failure in surgically treated patients using the American Society for Therapeutic Radiation and Oncology criteria
J Urol
(2002) - et al.
Cancer progression and survival rates following anatomical radical retropubic prostatectomy in 3,478 consecutive patients: long-term results
J Urol
(2004) - et al.
Sensitive prostate-specific antigen measurements identify men with long disease-free intervals and differentiate aggressive from indolent cancer recurrences within two years after radical prostatectomy
J Urol
(1997) - et al.
Prognostic significance of undetectable ultrasensitive prostate-specific antigen nadir after radical prostatectomy
Urology
(2010) - et al.
Ultrasensitive serum prostate specific antigen nadir accurately predicts the risk of early relapse after radical prostatectomy
J Urol
(2005) - et al.
Natural history of persistently elevated prostate specific antigen after radical prostatectomy: results from the SEARCH database
J Urol
(2009) - et al.
Defining prostate specific antigen progression after radical prostatectomy: what is the most appropriate cut point?
J Urol
(2001) - et al.
Biochemical recurrence without PSA progression characterizes a subset of patients after radical prostatectomy
Urology
(2003) - et al.
Comparison of preoperative prostate specific antigen density and prostate specific antigen for predicting recurrence after radical prostatectomy: results from the SEARCH database
J Urol
(2003)
Cancer statistics, 2004
CA Cancer J Clin
Natural history of progression after PSA elevation following radical prostatectomy
JAMA
Long-term survival after radical prostatectomy compared to other treatments in older men with local/regional prostate cancer
J Surg Oncol
Cited by (13)
Do Ultrasensitive Prostate Specific Antigen Measurements Have a Role in Predicting Long-Term Biochemical Recurrence-Free Survival in Men after Radical Prostatectomy?
2016, Journal of UrologyCitation Excerpt :However, it should be noted that approaches to the pathological examination of prostate tissue from patients treated with cystoprostatectomy compared to RP may miss prostate cancer foci. The distribution of PSA values in populations other than patients with prostate cancer has not been established in fourth and fifth-generation assays.12,13,16 The 44 post-cystoprostatectomy specimens in this study all had detectable PSA concentrations with the AccuPSA assay (greater than 0.035 pg/ml), and confirmed the 2 ultrasensitive Hybritech results between 0.01 and 0.1 ng/ml.
Editorial comment
2014, UrologyA framework to evaluate the cost-effectiveness of the NADiA prosvue slope to guide adjuvant radiotherapy among men with high-risk characteristics following prostatectomy for prostate cancer
2014, Value in HealthCitation Excerpt :NADiA ProsVue is a prognostic system that uses a highly sensitive immuno–polymerase chain reaction assay to measure extremely low concentrations (i.e., picograms) of prostate-specific antigen (PSA) across three blood samples taken on separate occasions from 1.5 to 20.0 months after prostatectomy. In an analysis of 304 patients from four clinical sites, the ProsVue PSA slope was a statistically significant predictor of clinical progression-free survival within Cancer of the Prostate Risk Assessment-Postsurgical (CAPRA-S) risk groups defined by six postsurgical risk factors: preoperative PSA level, surgical margins, seminal vesicle invasion, pathologic Gleason score, extracapsular extension, and lymph node invasion [12–14]. As a prognostic marker, the ProsVue slope is dichotomized to represent patients at reduced risk of clinical recurrence within 8 years (PSA ≤ 2 pg/mL/mo) and patients not at reduced risk for clinical recurrence (PSA > 2 pg/mL/mo).
Reply
2012, UrologyRecommendations on screening for prostate cancer with the prostate-specific antigen test
2014, CMAJCitation Excerpt :Several tests to supplement the PSA test in screening for prostate cancer have been developed in recent years. These tests are intended to detect cell activity in potentially malignant cells and are aimed at assessing risk during various stages, such as after a positive biopsy result,62 after a negative biopsy result63–65 and after surgery.66 These tests measure molecular markers, which typically indicate patterns of gene activity, such as expression of the PCA3 gene and other DNA mutations, which occur in the presence of a malignant tumour.
Financial Disclosure: Hans Lilja holds patents for free PSA, intact PSA, and hK2 assays and has stock or other ownership interests in Arctic Partners; Mark J. Sarno is a consultant to IRIS International, Inc.; Barbara Stevens is a consultant of IRIS International, Inc.; Robert E. Klem is employed by IRIS International, Inc. and has stock in IRIS International, Inc.; Jonathan E. McDermed is employed by IRIS International, Inc. and has stock in IRIS International, Inc.; Melissa T. Triebell is employed by IRIS International, Inc. and has stock in IRIS International, Inc.; Thomas H. Adams is Chief Technology Officer for, and has stock in, IRIS International, Inc.; remaining authors have no disclosures.
Funding Support: Patient samples from the University of Washington were collected in part using funding from the National Institutes of Health NW Prostate Cancer SPORE (grant CA-097186) and National Institutes of Health PO1 (grant CA-085859). Funding support to Memorial Sloan-Kettering Cancer Center was provided in part from the National Cancer Institute (grant P50-CA92629); Sidney Kimmel Center for Prostate and Urologic Cancers; David H. Koch through the Prostate Cancer Foundation.