The CPC Risk Calculator: A New App to Predict Prostate-specific Antigen Recurrence During Follow-up After Radical Prostatectomy.

BACKGROUND: It can be challenging to predict the risk of biochemical recurrence (BR) during follow-up after radical prostatectomy (RP) in men who have undetectable prostate-specific antigen (PSA), even years after surgery. OBJECTIVE: To establish and validate a contemporary nomogram that predicts the absolute risk of BR every year after RP in men with undetectable PSA while accounting for competing risks of death. DESIGN, SETTING, AND PARTICIPANTS: A total of 3746 patients from Rigshospitalet (Copenhagen, Denmark) and Stanford Urology (Stanford, CA, USA) who underwent RP between 1995 and 2013 were included. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Time to BR was defined as the first PSA result ≥0.2 ng/ml. BR risk was computed using multiple cause-specific Cox regression including preoperative PSA, pT category, RP Gleason score (GS), and surgical margin (R) status. Death without BR was considered a competing event. The nomogram presents the future risk of BR for a man who is alive and without BR at the time of follow-up. Validation assessed the discrimination and accuracy using time-dependent area under the curve and Brier scores. RESULTS AND LIMITATIONS: The nomogram predicts risk of BR up to 12 yr after RP at an individual level. As example, the risk of BR for a man with pT3a, R-, GS 3 + 4, and preoperative PSA ≤10 ng/ml followed for 5 yr with undetectable PSA is 18% for the next 5 yr. External validation demonstrated both high accuracy and discrimination. The CPC Risk Calculator is available as a free Android and iOS App. Declining discrimination and accuracy after 7 yr of follow-up is the main limitation. CONCLUSIONS: This nomogram can be used as a tool to inform men with undetectable PSA during follow-up after RP about their future risk of BR, and may aid in decisions on the necessity for further follow-up. The nomogram is the first to be available as a free app. PATIENT SUMMARY: We developed an easily interpretable nomogram to evaluate the risk of prostate-specific antigen elevation (cancer recurrence) following complete removal of the prostate (radical prostatectomy). The tool can aid both physicians and patients in evaluating the future risk of cancer recurrence during follow-up after surgery. The model is available as a free mobile app that can be downloaded from the App Store.

The risk of biochemical recurrence for intermediate-risk prostate cancer after radical prostatectomy.

OBJECTIVES: To report oncological outcomes including biochemical recurrence (BR) following radical prostatectomy (RP) from a large consecutive cohort operated in an 18-year period. Additionally, an in-depth analysis of outcomes among D'Amico intermediate-risk patients is presented. MATERIALS AND METHODS: A total of 2,091 patients with PCa who underwent RP at Department of Urology, Rigshospitalet, Copenhagen, Denmark between 1995 and 2013 were included. Univariate and multiple cause-specific Cox regression analyses for BR were applied using competing risk models. Death prior to BR was considered a competing event. BR was defined as the first PSA ≥0.2 ng/ml. No patient received adjuvant therapy prior to BR. RESULTS: Overall, the 5- and 10-years cumulative incidence of BR was 21.9% and 32.0%. The 10-year cumulative incidence of BR was 17.9%, 31.9% and 47.9% for D'Amico low-, intermediate- and high-risk patients, respectively. Among intermediate-risk patients, the 10-year cumulative incidence of BR was 24.0%, 39.9%, and 47.9% for patients harboring one, two or three risk factors, respectively (Gray test: p < 0.0001). In multivariate analysis, PSA, RP GS, pT category, and positive surgical margins were significantly associated with an increased risk of BR. CONCLUSIONS: The risk of BR among patients with intermediate-risk disease is not uniform and is highly dependent on the number of risk factors per patient. Intermediate-risk patients have a comparable risk of recurrence as high-risk patients, and this should be taken into consideration when counseling patients prior to RP.

Patients undergoing radical prostatectomy have a better survival than the background population.

INTRODUCTION: The objective of this study was to investigate standardised relative survival and mortality ratio for patients undergoing radical prostatectomy for localized prostate cancer at our institution. MATERIAL AND METHODS: Between 1995 and 2010, a total of 1,350 consecutive patients underwent radical prostatectomy. Patients were followed prospectively per protocol. No patients were lost to follow-up. Overall and cause-specific survival were described using Kaplan-Meier plots. Standardized relative survival and mortality ratio were calculated based on expected survival in the age-matched Danish population using the methods and macros described by Dickmann. The country-specific population mortality rates used for calculation of the expected survival were based on data from The Human Mortality Database. RESULTS: The median follow-up was 3.4 years (range: 0-14.3 years). A total of 59 (4.4%) patients died during follow-up. In all, 17 (1.3%) patients died of prostate cancer. The estimated ten-year overall survival was 89.3%. The cancer-specific survival was estimated to 96.6% after ten years. Relative survival was 1.04 after five years and 1.14 after ten years. The standardized mortality ratio, i.e. observed mortality/expected mortality, was 0.61 and 0.39 at five and ten years, respectively. CONCLUSION: The overall and cancer-specific ten-year survival in a consecutive series of patients in a non-screened Danish population is ≥ 89%. The survival and mortality ratio is significantly better than expected in the age-matched background population. This finding is likely explained by selection bias. Although the results indicate an excellent outcome in terms of cancer control, the efficacy of prostatectomy for localized prostate cancer remains at debate. FUNDING: not relevant. TRIAL REGISTRATION: not relevant.

Radical prostatectomy in clinically localized high-risk prostate cancer: outcome of 231 consecutive patients.

OBJECTIVE: The optimal therapeutic strategy for high-risk localized prostate cancer (PCa) is controversial. Supported by randomized trials, the combination of external beam radiation therapy (EBRT) and endocrine therapy (ET) is advocated by many, while radical prostatectomy (RP) is regarded as primary therapy by others. This study examined the outcome for high-risk localized PCa patients treated with RP. MATERIAL AND METHODS: Of 1300 patients who underwent RP, 231 were identified as high-risk. Patients were followed for biochemical recurrence (BCR) (defined as prostate-specific antigen ≥ 0.2 ng/ml), metastatic disease and survival. Excluding node-positive patients, none of the patients received adjuvant therapy before BCR was confirmed. Univariate and multivariate analysis was performed with Kaplan-Meier and Cox proportional hazard models. RESULTS: Median follow-up was 4.4 years (range:0.1-14.9). The estimated 10-year biochemical recurrence-free survival was 49%, 10-year metastasis-free survival was 81%, 10-year overall survival was 84% and estimated cause-specific survival after 10 years was 90%. In multivariate analysis extracapsular extension, seminal vesicle invasion and young age were significant predictors of BCR. CONCLUSION: The results confirm that a significant proportion of patients with high-risk PCa remain biochemically diseasefree and without a need for ET following RP as the primary and only treatment. A large randomized study of RP as primary therapeutic strategy versus the combination of EBRT and ET in patients with high-risk localized PCa seems warranted.

First Danish single-institution experience with radical prostatectomy: impact of surgical margins on biochemical outcome.

OBJECTIVE: This study aimed to investigate the impact of positive surgical margins (PSMs), stratified by location and extension, on biochemical outcome after radical retropubic prostatectomy (RRP). MATERIAL AND METHODS: The study included data from 605 consecutive patients treated with RRP for localized prostate cancer. Patients with node-positive disease were excluded. Biochemical recurrence-free survival was calculated using the Kaplan-Meier method. Univariate and multivariate analysis was used to assess risk factors. RESULTS: The overall PSM rate was 35.4%. Eighty-three per cent (82.7%) of these had a single PSM, whereas 17.3% of patients had two or more PSMs. Apical PSMs were present in 42.5% and non-apical in 57.5%. The presence of any PSM had a significant impact on the risk of biochemical recurrence (BR) [hazard ratio (HR) = 3.3, p < 0.0001]. Compared with margin-negative patients, both apical and non-apical PSMs increased the risk of BR (HR = 2.1 and 4.2, p = 0.02 and p < 0.0001, respectively). The number of PSMs also influenced the risk of BR (one PSM: HR = 2.8, p < 0.0001, vs two or more PSMs: HR = 5.5, p < 0.0001). In multivariate analysis, pT category, PSA and prostatectomy Gleason score independently increased the risk of BR. In an exploratory multivariate analysis of pT2 tumours, the impact of apical PSMs on biochemical recurrence-free survival (BRFS) was not statistically significant, although with an HR of 2.1. Non-apical PSM was associated with a significantly increased risk of BR (HR = 3.4, p = 0.01). Number of PSMs did not influence the risk of BR in multivariate analysis. CONCLUSION: The presence of PSMs after RRP is associated with a higher risk of BR. Multiple and non-apical PSMs are associated with a significantly higher risk of BR compared to single and apical PSMs.

Serum testosterone level as a predictor of biochemical failure after radical prostatectomy for localized prostate cancer.

OBJECTIVE: • To investigate serum testosterone levels as a predictor for biochemical failure (BF) after radical retropubic prostatectomy (RRP). PATIENTS AND METHODS: • Prospective cohort study with 227 patients and a median follow-up of 7.7 years. • Total serum testosterone was measured at diagnosis. • Primary endpoint: 5-year BF-free survival defined as first PSA > 0.2 ng/mL. • Testosterone was tested as a predictor of BF as a dichotomized and continuous variable. RESULTS: • Median (range) age was 62 years (45-74), median PSA 9.9 ng/mL (0.4-96), and median testosterone was 14 nmol/L (2.2-40). • BF occurred for 57 patients (26%) within 5 years. • In multivariate analysis with age, PSA, and biopsy Gleason score, testosterone levels >11 nmol/L were an independent predictor for reduced risk of BF (hazard ratio, 0.53; 95% confidence interval, 0.31-0.90; P= 0.02). • When analyzed as a continuous variable, testosterone was not a statistically significant predictor of BF. CONCLUSION: • Low pretreatment serum testosterone levels correlate with a higher risk of BF, and testosterone may possess biological information about prostate cancer progression potential, which makes it an independent predictor of biochemical failure after RRP.

First danish single-institution experience with radical prostatectomy: biochemical outcome in 1200 consecutive patients.

Radical retropubic prostatectomy (RRP) as intended curative therapy for patients with clinically localized prostate cancer (PC) was initiated in 1995 in Denmark. This paper reports single-institution results from the first 1200 consecutive patients operated during a 15-year period. Median age at surgery was 63 years. Median PSA was 9 ng/mL. Palpable tumors (≤cT2) were present in 48% of patients. Gleason score at biopsy was ≤7 for 85% of patients. In sixty-five percent of patients, histopathology revealed localized PCa after RRP. Positive surgical margins were found in 39.2% of the cases. Biochemical recurrence (BR) occurred for 214 (18%) of patients. The estimated biochemical recurrence free survival (BRFS) was 71.7% and 63.2% after 5 and 10 years, respectively. When patients were stratified according to the D'Amico criteria, BRFS after 10 years was 75.3%, 59.7%, and 39.3% for low-, medium- and high-risk patients, respectively. In univariate analysis, clinical stage, PSA at diagnosis and type of surgery were significant predictors of BR. In multivariate analysis, Gleason score > 7, PSA > 10, and higher clinical stage were significant predictors of BR. Early Danish results in a population not subjected to screening demonstrate BRFS rates comparable with earlier reports from the prescreening era.

[Early complications following open radical prostatectomy]. / Tidlige komplikationer efter åben radikal prostatektomi.

INTRODUCTION: Radical prostatectomy has been offered as curative treatment for localized prostate cancer at Rigshospitalet since August 1995. We here report on postoperative complications in 719 patients operated during the 12-year-period from August 1995 to August 2007 with special emphasis on developments over time. MATERIAL AND METHODS: A retrospective review. RESULTS: Median age at surgery was 63 years with a significant increase from 61 to 64 during the 12-year-period. We found no change in clinical preoperative T-category, whereas the median pre-treatment PSA decreased significantly. This reflects increased surgical experience and an optimized postoperative course. Significant reductions in operating time, need for blood transfusions, and length of hospitalisation were recorded. One or more complications were registered in 164 patients (22.8%); severe complications occurred in eight patients (1,1%). One patient died within 30 days after surgery. CONCLUSION: Our results demonstrate that radical prostatectomy can be performed with a minimal mortality and an acceptable morbidity.