NCCN Guidelines® Insights: Prostate Cancer, Version 3.2024.

The NCCN Guidelines for Prostate Cancer include recommendations for staging and risk assessment after a prostate cancer diagnosis and for the care of patients with localized, regional, recurrent, and metastatic disease. These NCCN Guidelines Insights summarize the panel's discussions for the 2024 update to the guidelines with regard to initial risk stratification, initial management of very-low-risk disease, and the treatment of nonmetastatic recurrence.

Prostate Cancer, Version 4.2023, NCCN Clinical Practice Guidelines in Oncology.

The NCCN Guidelines for Prostate Cancer provide a framework on which to base decisions regarding the workup of patients with prostate cancer, risk stratification and management of localized disease, post-treatment monitoring, and treatment of recurrence and advanced disease. The Guidelines sections included in this article focus on the management of metastatic castration-sensitive disease, nonmetastatic castration-resistant prostate cancer (CRPC), and metastatic CRPC (mCRPC). Androgen deprivation therapy (ADT) with treatment intensification is strongly recommended for patients with metastatic castration-sensitive prostate cancer. For patients with nonmetastatic CRPC, ADT is continued with or without the addition of certain secondary hormone therapies depending on prostate-specific antigen doubling time. In the mCRPC setting, ADT is continued with the sequential addition of certain secondary hormone therapies, chemotherapies, immunotherapies, radiopharmaceuticals, and/or targeted therapies. The NCCN Prostate Cancer Panel emphasizes a shared decision-making approach in all disease settings based on patient preferences, prior treatment exposures, the presence or absence of visceral disease, symptoms, and potential side effects.

NCCN Guidelines® Insights: Prostate Cancer, Version 1.2023.

The NCCN Guidelines for Prostate Cancer address staging and risk assessment after a prostate cancer diagnosis and include management options for localized, regional, recurrent, and metastatic disease. The NCCN Prostate Cancer Panel meets annually to reevaluate and update their recommendations based on new clinical data and input from within NCCN Member Institutions and from external entities. These NCCN Guidelines Insights summarizes much of the panel's discussions for the 4.2022 and 1.2023 updates to the guidelines regarding systemic therapy for metastatic prostate cancer.

TMPRSS2-ERG fusion impacts anterior tumor location in men with prostate cancer.

BACKGROUND: In prostate cancer (PCa), lack of androgen receptor (AR) regulated TMPRSS2-ETS-related gene (ERG) gene fusion (ERGnegative ) status has been associated with African American race; however, the implications of ERG status for the location of dominant tumors within the prostate remains understudied. METHODS: An African American-enriched multiinstitutional cohort of 726 PCa patients consisting of both African American men (AAM; n = 254) and European American men (EAM; n = 472) was used in the analyses. Methods of categorical analysis were used. Messenger RNA (mRNA) expression differences between anterior and posterior tumor lesions were analyzed using Wilcoxon rank-sum tests with multiple comparison corrections. RESULTS: Anti-ERG immunohistochemistry staining showed that the association between ERG status and anterior tumors is independent of race and is consistently robust for both AAM (ERGnegative 81.4% vs. ERGpositive 18.6%; p = .005) and EAM (ERGnegative 60.4% vs. ERGpositive 39.6%; p < .001). In a multivariable model, anterior tumors were more likely to be IHC-ERGnegative (odds ratio [OR]: 3.20; 95% confidence interval [CI]: 2.14-4.78; p < .001). IHC-ERGnegative were also more likely to have high-grade tumors (OR: 1.73; 95% CI: 1.06-2.82; p = .02). In the exploratory genomic analysis, mRNA expression of location-dependent genes is highly influenced by ERG status and African American race. However, tumor location did not impact the expression of AR or the major canonical AR-target genes (KLK3, AMACR, and MYC). CONCLUSIONS: ERGnegative tumor status is the strongest predictor of anterior prostate tumors, regardless of race. Furthermore, AR expression and canonical AR signaling do not impact tumor location.

NCCN Guidelines Insights: Prostate Cancer, Version 1.2021.

The NCCN Guidelines for Prostate Cancer address staging and risk assessment after a prostate cancer diagnosis and include management options for localized, regional, and metastatic disease. Recommendations for disease monitoring and treatment of recurrent disease are also included. The NCCN Prostate Cancer Panel meets annually to reevaluate and update their recommendations based on new clinical data and input from within NCCN Member Institutions and from external entities. This article summarizes the panel's discussions for the 2021 update of the guidelines with regard to systemic therapy for metastatic castration-resistant prostate cancer.

Effectiveness and Safety of Prostatic Artery Embolization for the Treatment of Lower Urinary Tract Symptoms from Benign Prostatic Hyperplasia in Men with Concurrent Localized Prostate Cancer.

PURPOSE: To assess the effectiveness and safety of prostatic artery embolization (PAE) on lower urinary tract symptoms (LUTS) in the setting of localized prostate cancer (PCa). MATERIALS AND METHODS: This was a retrospective, single-center, institutional review board-approved study from December 2016 to June 2020 of 21 patients (median age, 72; range, 63-83 years) with moderate LUTS and localized PCa. Clinical effectiveness was evaluated at 6 and 12 weeks using International Prostate Symptom Score (IPSS) and quality of life (QoL) improvement. Seventeen patients were scheduled to receive definitive radiotherapy (RT) after PAE; 13 patients completed RT. Short-term imaging signs of oncologic progression were evaluated at 6 and 12 weeks defined by at least one of the following on magnetic resonance imaging: increased Prostate Imaging-Reporting and Data System score of index lesion(s) to at least 4, new extracapsular extension, seminal vesicle involvement, or pelvic lymphadenopathy. Nonparametric Wilcoxon signed-rank test was used for analysis. RESULTS: IPSS improved by a median of 12 (n = 19, P < .0001) and 14 (n = 14, P < .0001) at 6 and 12 weeks, respectively. QoL improved by a median of 2 (n = 19, P < .0001) and 3 (n = 3, P < .0001) at 6 and 12 weeks. Prostate volume decreased by a median of 24% (n = 19, P < .0001) and 36% (n = 12, P = .015) at 6 and 12 weeks. No patients demonstrated disease progression at 6 (n = 16) or 12 (n = 8) weeks by imaging. No patients experienced increased prostate-specific antigen after RT, grade ≥3 adverse events, or greater genitourinary toxicity. CONCLUSIONS: PAE is effective and safe for the treatment of men with LUTS from benign prostatic hyperplasia in the setting of concomitant, localized, non-obstructive PCa.

Focal bipolar radiofrequency ablation for localized prostate cancer: Safety and feasibility.

OBJECTIVES: To evaluate the safety and feasibility of focal bipolar radiofrequency ablation in men with localized prostate cancer. METHODS: A review of 10 patients treated with a novel bipolar radiofrequency ablation probe integrated in a coil design (Encage; Trod Medical, Bradenton, FL, USA) between 2011 and 2017 in two prospective pilot trials. All men had clinical stage T1c prostate cancer, prostate-specific antigen <10 ng/mL and Gleason score ≤7. Ablation was carried out under general anesthesia, and bipolar probes were inserted transperineally under transrectal ultrasound guidance. Treatment-related adverse events, quality of life and negative biopsy rate were evaluated at 6 months after ablation. The Wilcoxon signed-rank test was used to compare baseline and post-treatment symptom scores. RESULTS: The median age was 58 years (range 50-64 years) and the median prostate volume was 49.65 cc (range 21-68 cc). Prostate cancer with a Gleason score of 6 (3 + 3) and 7 (3 + 4) was noted in seven and three patients, respectively. The median number of radiofrequency ablation cycles was 2.5 (range 2-5). All patients were catheter-free and able to void the day of surgery. Within 6 months after ablation, all adverse events were low grade, with the exception of one grade 3 hematuria that required cystoscopy without coagulation. Six months after ablation bowel, urinary and hormonal functions, and overall satisfaction remained stable. Erectile dysfunction occurred in two out of four patients who had normal sexual function before the procedure. Neither urinary incontinence nor urinary infection was noted. CONCLUSIONS: This first report on focal bipolar radiofrequency ablation documents a safe and feasible treatment option for selected patients with localized prostate cancer.

AA9int: SNP interaction pattern search using non-hierarchical additive model set.

Motivation: The use of single nucleotide polymorphism (SNP) interactions to predict complex diseases is getting more attention during the past decade, but related statistical methods are still immature. We previously proposed the SNP Interaction Pattern Identifier (SIPI) approach to evaluate 45 SNP interaction patterns/patterns. SIPI is statistically powerful but suffers from a large computation burden. For large-scale studies, it is necessary to use a powerful and computation-efficient method. The objective of this study is to develop an evidence-based mini-version of SIPI as the screening tool or solitary use and to evaluate the impact of inheritance mode and model structure on detecting SNP-SNP interactions. Results: We tested two candidate approaches: the 'Five-Full' and 'AA9int' method. The Five-Full approach is composed of the five full interaction models considering three inheritance modes (additive, dominant and recessive). The AA9int approach is composed of nine interaction models by considering non-hierarchical model structure and the additive mode. Our simulation results show that AA9int has similar statistical power compared to SIPI and is superior to the Five-Full approach, and the impact of the non-hierarchical model structure is greater than that of the inheritance mode in detecting SNP-SNP interactions. In summary, it is recommended that AA9int is a powerful tool to be used either alone or as the screening stage of a two-stage approach (AA9int+SIPI) for detecting SNP-SNP interactions in large-scale studies. Availability and implementation: The 'AA9int' and 'parAA9int' functions (standard and parallel computing version) are added in the SIPI R package, which is freely available at https://linhuiyi.github.io/LinHY_Software/. Supplementary information: Supplementary data are available at Bioinformatics online.

Prostate cancer mortality rates in Peru and its geographical regions.

OBJECTIVE: To evaluate the mortality rates for prostate cancer according to geographical areas in Peru between 2005 and 2014. MATERIALS AND METHODS: Information was extracted from the Deceased Registry of the Peruvian Ministry of Health. We analysed age-standardised mortality rates (world population) per 100 000 men. Spatial autocorrelation was determined according to the Moran Index. In addition, we used Cluster Map to explore relations between regions. RESULTS: Mortality rates increased from 20.9 (2005-2009) to 24.1 (2010-2014) per 100 000 men, an increase of 15.2%. According to regions, during the period 2010-2014, the coast had the highest mortality rate (28.9 per 100 000), whilst the rainforest had the lowest (7.43 per 100 000). In addition, there was an increase in mortality in the coast and a decline in the rainforest over the period 2005-2014. The provinces with the highest mortality were Piura, Lambayeque, La Libertad, Callao, Lima, Ica, and Arequipa. Moreover, these provinces (except Arequipa) showed increasing trends during the years under study. The provinces with the lowest observed prostate cancer mortality rates were Loreto, Ucayali, and Madre de Dios. This study showed positive spatial autocorrelation (Moran's I: 0.30, P = 0.01). CONCLUSION: Mortality rates from prostate cancer in Peru continue to increase. These rates are higher in the coastal region compared to those in the highlands or rainforest.

Prostate Cancer, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology.

The NCCN Guidelines for Prostate Cancer include recommendations regarding diagnosis, risk stratification and workup, treatment options for localized disease, and management of recurrent and advanced disease for clinicians who treat patients with prostate cancer. The portions of the guidelines included herein focus on the roles of germline and somatic genetic testing, risk stratification with nomograms and tumor multigene molecular testing, androgen deprivation therapy, secondary hormonal therapy, chemotherapy, and immunotherapy in patients with prostate cancer.

SNP interaction pattern identifier (SIPI): an intensive search for SNP-SNP interaction patterns.

Motivation: Testing SNP-SNP interactions is considered as a key for overcoming bottlenecks of genetic association studies. However, related statistical methods for testing SNP-SNP interactions are underdeveloped. Results: We propose the SNP Interaction Pattern Identifier (SIPI), which tests 45 biologically meaningful interaction patterns for a binary outcome. SIPI takes non-hierarchical models, inheritance modes and mode coding direction into consideration. The simulation results show that SIPI has higher power than MDR (Multifactor Dimensionality Reduction), AA_Full, Geno_Full (full interaction model with additive or genotypic mode) and SNPassoc in detecting interactions. Applying SIPI to the prostate cancer PRACTICAL consortium data with approximately 21 000 patients, the four SNP pairs in EGFR-EGFR , EGFR-MMP16 and EGFR-CSF1 were found to be associated with prostate cancer aggressiveness with the exact or similar pattern in the discovery and validation sets. A similar match for external validation of SNP-SNP interaction studies is suggested. We demonstrated that SIPI not only searches for more meaningful interaction patterns but can also overcome the unstable nature of interaction patterns. Availability and Implementation: The SIPI software is freely available at http://publichealth.lsuhsc.edu/LinSoftware/ . Contact: hlin1@lsuhsc.edu. Supplementary information: Supplementary data are available at Bioinformatics online.

Epidural anesthesia and cancer outcomes in bladder cancer patients: is it the technique or the medication? A matched-cohort analysis from a tertiary referral center.

BACKGROUND: The perioperative period can be a critical period with long-term implications on cancer-related outcomes. In this study, we evaluate the influence of regional anesthesia on cancer-specific outcomes in a radical cystectomy (RC) cohort of patients. METHODS: We performed a retrospective analysis of patients with clinically-nonmetastatic urothelial carcinoma of the bladder who underwent RC at our institution from 2008 to 2012. Patients were retrospectively registered and stratified based on two anesthetic techniques: perioperative epidural analgesia with general anesthesia (epidural) versus general anesthesia alone (GA). Epidural patients received a sufentanil-based regimen (median intraoperative sufentanil dose 50 mcg (45,85). Propensity-score was used to make 1:1 case-control matching. Cumulative risk of recurrence with competing risks was calculated based on anesthetic technique. Kaplan-Meier curves were used to compare recurrence-free (RFS) and cancer-specific survival (CSS). Univariable and multivariable analyses were performed with Cox proportional hazard regression models for RFS and CSS. RESULTS: Only patients with complete data on anesthetic technique were included. Out of 439 patients, 215-pair samples with complete follow-up were included in the analysis. Median follow-up was 41.4 months (range: 0.20-101). Patients with epidurals received higher median total intravenous morphine equivalents (ivMEQ) versus those in the GA group (75 (11-235) vs. 50 ivMEQ (7-277), p < 0.0001). Cumulative risk of recurrence at two years was 25.2% (19.6, 31.2) for epidural patients vs. 20.0% (15.0, 25.7) for GA patients (Gray test p = 0.0508). Epidural analgesic technique was a significant predictor of worse RFS (adjusted HR = 1.67, 1.14-2.45; p = 0.009) and CSS (HR = 1.53, 1.04-2.25; p = 0.030) on multivariable analyses. CONCLUSIONS: Epidural anesthesia using sufentanil was associated with worse recurrence and disease-free survival in bladder cancer patients treated with surgery. This may be due use of epidural sufentanil or due to the increased total morphine equivalents patient received as a consequence of this drug.

Delay to Inguinal Lymph Node Dissection Greater than 3 Months Predicts Poorer Recurrence-Free Survival for Patients with Penile Cancer.

PURPOSE: To our knowledge it is unknown whether concomitant inguinal lymph node dissection at the time of penectomy improves outcomes in patients with penile cancer. We analyzed predictors of regional recurrence as well as disease specific survival based on time of inguinal lymph node dissection. We also determined an optimal time to perform inguinal lymph node dissection. MATERIALS AND METHODS: We reviewed the records of 84 consecutive patients with available nodal pathology findings. Recurrence-free and disease specific survival was estimated using the Kaplan-Meier method. Optimal time to inguinal lymph node dissection was assessed by ROC curves and used for dichotomization. Cox proportional HRs were used to identify predictors of regional recurrence after inguinal lymph node dissection. RESULTS: A total of 47 (56%) and 37 patients (44%) presented with cN0 and cN+ disease, respectively, during a median followup of 21 months. A cutoff point of 3 months to perform inguinal lymph node dissection was used to dichotomize the cohort into early vs delayed groups. Early dissection in 51 men demonstrated 5-year recurrence-free survival of 77% vs 37.8% in 33 who underwent delayed dissection. Positive node disease (HR 23.2, 95% CI 2.98-181.2) and early inguinal lymph node dissection (HR 0.48, 95% CI 0.21-0.98) were predictors of regional recurrence. Five-year disease specific survival was 64.1% and 39.5% in the early and late dissection groups, respectively. CONCLUSIONS: Three months appears to be an optimal window for performing inguinal lymph node dissection. While prospective trials are needed to define the role of upfront groin dissection, our results may help delineate patterns of referral and timing of inguinal lymph node dissection in patients with penile cancer.

Surgical control and margin status after robotic and open cystectomy in high-risk cases: Caution or equivalence?

PURPOSE: The benefits of robotic-assisted radical cystectomy (RARC) are unclear, especially in patients with high-risk disease (pT3/T4). We evaluated pathological and postoperative outcomes of RARC versus open radical cystectomy (ORC) in these patients. METHODS: We identified bladder cancer patients treated with RARC or ORC from January 2010-August 2014. Clinicodemographic factors were examined for potential confounding. Our primary outcome of interest was positive soft-tissue surgical margins (STSMs). Secondary outcomes included post-operative complications and length of stay (LOS). We used logistic regression to define the association between clinical factors with outcomes of interest, focusing on patients with locally advanced disease. RESULTS: We identified 472 patients treated with ORC (407, 86.2 %) or RARC (65, 13.8 %) of which 215 (45.6 %) were high-risk cases based on advanced pathologic stage (pT3/4). RARC patients were more commonly men (96.9 vs. 73.2 %, p < 0.01), had better performance status (ECOG 0, 78.5 vs. 59.7 %, p = 0.031), and received less neoadjuvant chemotherapy (21.5 vs. 39.3 %, p = 0.006). Total (52.3 vs. 59.7 %, p = 0.26) and high-grade complication rates (13.8 vs. 19.7 %, p = 0.27) were similar, but median LOS was shorter after RARC (6 vs. 7 days, p < 0.01). On multivariate analysis, prior pelvic radiation (OR: 4.78, 95 % CI: 2.16-10.57), and advanced tumor stage (OR: 3.06, 95 % CI: 1.56-6.03) were independently associated with positive STSMs in high-risk patients but robotic surgical approach was not (OR: 0.81, 95 % CI: 0.29-2.30; p = 0.69). CONCLUSION: RARC had similar short-term postoperative outcomes compared to ORC and did not compromise oncological control in patients with extravesical disease.

Preoperative Patient Reported Mental Health is Associated with High Grade Complications after Radical Cystectomy.

PURPOSE: Psychological distress has been associated with an impaired immune response and poor wound healing. We hypothesized that preoperative patient reported mental health would be associated with high grade 30-day complications after radical cystectomy. MATERIALS AND METHODS: We retrospectively identified patients who underwent radical cystectomy for bladder cancer who completed Short Form 12 (SF-12) surveys for self-assessment of health status less than 6 months before surgery. Median physical and mental composite scores were calculated. An expert model including known predictors of postoperative high grade complications was developed, and SF-12 physical composite score and mental composite score were added to determine their association with this end point. RESULTS: From January 2010 to August 2014, 472 patients underwent radical cystectomy for bladder cancer, of whom 274 (58.1%) completed preoperative SF-12 questionnaires. Responders were more likely to be white (p=0.024), have higher preoperative albumin (p=0.037), receive neoadjuvant chemotherapy (p=0.002), have pT3/T4 disease (p=0.044) and have positive soft tissue surgical margins (p=0.006). Median SF-12 physical composite score was 43.1 (IQR 33.0-51.5) and mental composite score was 48.5 (IQR 39.5-54.7) in responders. Overall 46 (16.8%) responders experienced a high grade 30-day complication. Patients with a high grade complication had a lower preoperative median SF-12 mental composite score (44.8 vs 49.8, p=0.004) but no difference in physical composite score (39.2 vs 43.8, p=0.06). SF-12 mental composite score was also a significant predictive variable when added to our expert model (p=0.01). CONCLUSIONS: Preoperative patient reported mental health was independently associated with high grade complications after radical cystectomy. Therefore, patient self-assessment of health status before surgery through validated questionnaires may provide additional information useful in predicting short-term postoperative outcomes.

Prostate Cancer, Version 1.2016.

The NCCN Guidelines for Prostate Cancer address staging and risk assessment after an initial diagnosis of prostate cancer and management options for localized, regional, and metastatic disease. Recommendations for disease monitoring, treatment of recurrent disease, and systemic therapy for metastatic castration-recurrent prostate cancer also are included. This article summarizes the NCCN Prostate Cancer Panel's most significant discussions for the 2016 update of the guidelines, which include refinement of risk stratification methods and new options for the treatment of men with high-risk and very-high-risk disease and progressive castration-naïve disease.

Clinical role of additional adjuvant chemotherapy in patients with locally advanced urothelial carcinoma following neoadjuvant chemotherapy and cystectomy.

PURPOSE: Neoadjuvant chemotherapy (NAC) can downstage invasive bladder cancers prior to radical cystectomy (RC) and improve overall survival. However, the optimal management in patients with persistent non-organ confined disease (pT3-T4 and/or pN+) following RC has not been completely defined. The aim of this study was to describe outcomes associated with the use of adjuvant chemotherapy (AC) in patients with residual non-organ confined cancer at RC following NAC. MATERIALS AND METHODS: Using data from a high-volume referral institution, pT3-T4 and/or pN+ patients who received NAC and then also RC were identified. Recurrence-free survival (RFS) and cancer-specific survival (CSS) were assessed with Kaplan-Meier analysis. RESULTS: From 2001 to 2013, 161 patients received NAC and then RC. Eighty-eight pT3-T4 and/or pN+ patients were identified. Twenty-nine (33 %) received AC. Adjuvant chemotherapy in the majority of patients was carboplatin-based (16), followed by cisplatin (8) and other, mainly taxane-containing regimens (5). The median RFS was 17.5 months in the AC and 13.7 months in the non-AC group (p = 0.78). AC remained an insignificant predictor for RFS after adjusting for pT, pN and margin status (HR 0.89, 95 % CI 0.48-1.68]). CSS was 23 and 22 months (p = 0.65) and remained insignificant after adjusting for pathologic confounders. CONCLUSIONS: In our current study population, adjuvant conventional cytotoxic chemotherapy was not associated with significant improvements in RFS or CSS. The choice of AC regimens, and incorporation of newer treatments, may be the key for improving outcomes in this high-risk patient group.

Geographical Factors Associated With Health Disparities in Prostate Cancer.

BACKGROUND: Treatment variation in prostate cancer is common, and it is driven by clinical and clinician factors, patient preferences, availability of resources, and access to physicians and treating facilities. Most research on treatment disparities in men with prostate cancer has focused on race and socioeconomic factors. However, the geography of disparities - capturing racial and socioeconomic differences based on where patients live - can provide insight into barriers to care and help identify outlier areas in which access to care, health resources, or both are more pronounced. METHODS: Research regarding treatment patterns and disparities in prostate cancer using the Geographical Information System (GIS) was searched. Studies were limited to English-language articles and research focused on US populations. A total of 43 articles were found; of those, 30 provided information about or used spatial or geographical analyses to assess and describe differences or disparities in prostate cancer and its treatment. Two additional GIS resources were included. RESULTS: The research on geographical and spatial determinants of prostate cancer disparities was reviewed. We also examined geographical analyses at the state level, focusing on Florida. Overall, we described a geographical framework to disparities that affect men with prostate cancer and reviewed existing published evidence supporting the interplay of geographical factors and disparities in prostate cancer. CONCLUSIONS: Disparities in prostate cancer are common and persistent, and notable differences in treatment are observable across racial and socioeconomic strata. Geographical analysis provides additional information about where disparate groups live and also helps to map access to care. This information can be used by public health officials, health-systems administrators, clinicians, and policymakers to better understand and respond to geographical barriers that contribute to disparities in care.

Chemoprevention in African American Men With Prostate Cancer.

BACKGROUND: Recommendations for cancer screening are uncertain for the early detection or prevention of prostate cancer in African American men. Thus, chemoprevention strategies are needed to specifically target African American men. METHODS: The evidence was examined on the biological etiology of disparities in African Americans related to prostate cancer. Possible chemopreventive agents and biomarkers critical to prostate cancer in African American men were also studied. RESULTS: High-grade prostatic intraepithelial neoplasia may be more prevalent in African American men, even after controlling for age, prostate-specific antigen (PSA) level, abnormal results on digital rectal examination, and prostate volume. Prostate cancer in African American men can lead to the overexpression of signaling receptors that may mediate increased proliferation, angiogenesis, and decreased apoptosis. Use of chemopreventive agents may be useful for select populations of men. CONCLUSIONS: Green tea catechins are able to target multiple pathways to address the underlying biology of prostate carcinogenesis in African American men, so they may be ideal as a chemoprevention agent in these men diagnosed with high-grade prostatic intraepithelial neoplasia.

Long term survival and predictors of disease reclassification in patients on an active surveillance protocol for prostate cancer.

INTRODUCTION: Up to 50% of patients will have disease reclassification while on active surveillance (AS) for their prostate cancer. Determining which patients will have reclassification that will impact their survival is difficult. We investigated clinicopathologic factors associated with disease reclassification and differences in both overall and metastasis free survival between those treated and those remaining on AS. MATERIALS AND METHODS: We performed a retrospective review of patients who were enrolled in an AS protocol between 1994 and 2000. Inclusion criteria for AS were: < cT2a disease, PSA < 10 ng/mL, < 50% of single core involvement, and Gleason score < 7, as well as sufficient follow up for evaluation (at least 1 subsequent transrectal ultrasound guided biopsy after initial diagnosis). RESULTS: There were 102 patients that met the inclusion criteria with median age of 70 years (IQR 68-73), follow up of 9.25 years (IQR 6.1-12.2) and time to disease reclassification of 4.7 years (IQR 2.8-7.9). Only prostate-specific antigen (PSA) density ≥ 0.15 was a significant predictor of disease reclassification with a hazard ratio of 5.5 (95% confidence interval 2.3-13.4, p < 0.01). There was no significant difference in metastasis free and overall survival between patients who received treatment and those that continued on AS despite reclassification of disease; this remained true even while stratifying patients by age ≥ 70 compared to those < 70 years old. CONCLUSIONS: PSA density is a significant predictor of disease reclassification and AS remains a safe option for patients with low risk prostate cancer with up to 10 years of follow up.