The Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE™) is a national disease registry accruing men with biopsy-proven prostate adenocarcinoma, recruited from 40 urology practices, primarily community-based, across the United States. Informed consent is obtained from each patient under institutional review board supervision. Patients are treated according to their physicians’ usual practices, and are followed until time of death or withdrawal from the study. Additional details have been reported previously.13 (link), 14 (link) Eligibility for inclusion in the study was limited to men with prostate cancer diagnosed since 1992 who underwent prostatectomy as primary treatment and had at least six months of followup recorded in the registry. Those with clinically advanced disease (>cT3aN0M0) pre-operatively were ineligible, as were those had received neoadjuvant or adjuvant hormonal and/or radiation.
Detailed reporting of staging variables (ECE, SVI, SM) is variable among pathology reports accessioned to CaPSURE. In the main analysis, ECE, SVI, or SM reported as “unable to assess” were assumed to be negative; in a sensitivity analysis, cases without complete data for all variables were dropped. To examine whether cases with missing pathologic data (ECE, SVI, SM) differed from cases with complete data, we compared these groups with respect to their distributions of the original preoperative CAPRA score using a Wilcoxon rank-sum statistic. In all cases, patients with no lymphadenectomy performed were assumed to have negative LNI. Patients missing pathologic Gleason score and/or preoperative PSA were excluded.
The definition of biochemical recurrence was either 2 consecutive PSA values over 0.2 ng/ml15 (link) or any secondary treatment at least six months following surgery (treatment within six months was assumed to be adjuvant). Men not experiencing recurrence—including those dying of other causes—were censored at date of the last available PSA.
Detailed reporting of staging variables (ECE, SVI, SM) is variable among pathology reports accessioned to CaPSURE. In the main analysis, ECE, SVI, or SM reported as “unable to assess” were assumed to be negative; in a sensitivity analysis, cases without complete data for all variables were dropped. To examine whether cases with missing pathologic data (ECE, SVI, SM) differed from cases with complete data, we compared these groups with respect to their distributions of the original preoperative CAPRA score using a Wilcoxon rank-sum statistic. In all cases, patients with no lymphadenectomy performed were assumed to have negative LNI. Patients missing pathologic Gleason score and/or preoperative PSA were excluded.
The definition of biochemical recurrence was either 2 consecutive PSA values over 0.2 ng/ml15 (link) or any secondary treatment at least six months following surgery (treatment within six months was assumed to be adjuvant). Men not experiencing recurrence—including those dying of other causes—were censored at date of the last available PSA.