Characterization of ASP8374, a fully-human, antagonistic anti-TIGIT monoclonal antibody.

The T-cell immunoreceptor with Ig and immunoreceptor tyrosine-based inhibitory motif (ITIM) domains (TIGIT) is a validated immune checkpoint protein expressed on memory CD4+T-cellls, Tregs, CD8+T-cell and natural killer (NK) cells. ASP8374 is a fully human monoclonal immunoglobulin (Ig) G4 antibody designed to block the interaction of TIGIT with its ligands and inhibit TIGIT signaling. ASP8374 exhibited high affinity binding to TIGIT and increased interferon (IFN)-γ production of cultured peripheral blood mononuclear cells (PBMCs) in a titratable manner. When used in combination with pembrolizumab, an anti-programmed death-1 (PD-1) antibody, ASP8374 induced higher T-cell activation in vitro than either treatment alone. An anti-mouse TIGIT antibody surrogate, mSEC1, displayed anti-tumor efficacy in an MC38 syngeneic mouse tumor model alone and in combination with an anti-programmed death-ligand 1 (PD-L1) antibody. In an additional syngeneic mouse tumor model (CT26), while mSEC1 alone did not demonstrate anti-tumor efficacy, mSEC1 combined with an anti-PD-1 antibody enhanced anti-tumor efficacy above that of the anti-PD-1 antibody alone. These data provide evidence that ASP8374 has therapeutic potential for advanced malignancies.

Single assistant versus dual assistant robotic surgery for robot-assisted laparoscopic hysterectomy using da Vinci Xi or X.

BACKGROUND: To verify the usefulness of single assistant robotic surgery (SA-RS) using da Vinci Xi or X performed for total hysterectomy. METHODS: The SA-RS group (S-group) includes surgeries in which the surgeon performed all surgical operations other than that of the uterine manipulator, while the dual assistant robotic surgery group (D-group) includes surgeries performed by the surgeon with two assistants. In S-group, the forceps and camera were replaced during surgery in cases of a large uterus with limited range of motion of the instrument. A comparative study of patient background, intraoperative and postoperative results and surgery-related cost was performed between the two groups. RESULTS: No significant differences were observed between the two groups. On the contrary, S-group showed a significant reduction in preparation time and wound closure time, and a savings of $768. CONCLUSION: SA-RS for total hysterectomy was possible, which is excellent in terms of cost, esthetics, and manpower.

[Current Status of Prostate Cancer and Its Relation to Home Medical Care].

Because ofboth the indolent and aggressive nature ofprostate cancers, it is not easy to select the best treatment for patients receiving home medical care who already have many diseases. Since the growth ofprostate cancer is generally slow and all treatments adversely affect the quality of life to some degree, conservative treatment may well be the best option for these patients with prostate cancer. However, it is also true that we often encounter home medical care patients with a locally advanced cancer who had symptoms such as difficulty to urine, macrohematuria and/or lumbago. Such patients need to be diagnosed soon and treated with mainly hormonal therapy after consultation with the specialist. Thus, after a careful evaluation ofthe nature ofthe cancer and comorbidity, we need to provide the best option ofdiagnosis and treatment for home medical care patients to maintain their quality of life.

Prognostic Value of Platelet Counts in Patients with Metastatic Prostate Cancer Treated with Endocrine Therapy.

PURPOSE: The endocrine therapy is effective for patients with advanced prostate cancer, but the disease eventually becomes refractory to treatment. The aim of this study was to investigate prognostic factors and to develop a risk stratification model for survival in patients with advanced prostate cancer undergoing endocrine therapy. MATERIALS AND METHODS: This study included 197 patients with stage IV prostate cancer who were treated with endocrine therapy as primary treatment at Tokyo Medical University, Tokyo, Japan, between January 1999 and November 2012. Prognostic values including baseline clinical laboratory values before endocrine therapy for stage IV prostate cancer were examined. Patients (n = 30) who were not followed or for whom data were unavailable or who were treated with radiotherapy were excluded from the study. Excluding these patients, we retrospectively analyzed 167 patients who were treated with endocrine therapy as the primary treatment. Disease-specific survival (DSS) was evaluated using the Kaplan-Meier method, and prognostic factors were identified using the Cox proportional hazard model analysis. RESULTS: In univariate analyses, patients with a performance status (PS) ? 2, platelet count ? 3.0× 105 µ/L, prostate specific antigen (PSA) > 50 ng/mL, alkaline phosphatase (ALP) > 350 U/L, lactate dehydrogenase (LDH) > 240 IU/L, and Gleason score (GS) ? 8, hemoglobin (Hb) < 12 g/dL, extent of disease (EOD) ? 3 and poorly differentiated adenocarcinoma showed significantly lower DSS than their respective counterparts. Neutrophil-to-Lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR) and white blood cell (WBC) count were not significantly associated with DSS. In a multivariate Cox proportional hazard model, PS and platelet count were independent prognostic factors. Based on the hazard rate (HR) calculated by the following formula: HR = exp (0.82 × PS + 1.38 × platelet count) patients were stratified into 3 risk groups. The differences in DSS rates among the 3 groups were statistically significant. CONCLUSION: These results suggest that PS and platelet count are independent prognostic factors and that a combination of these factors can be used to stratify metastatic prostate cancer patients treated with endocrine therapy according to their DSS risk.

Prognostic significance of the presence of tertiary Gleason grade 5 in robot-assisted radical prostatectomy specimens in Japanese patients with clinically localized prostate cancer.

BACKGROUND: The aim of this study was to study the prognostic significance of tertiary Gleason grade (TGG) 5 in patients with clinically localized prostate cancer treated with robot-assisted radical prostatectomy (RARP). METHODS: A total of 600 Japanese patients who underwent RARP for clinical stage T1-3N0M0 prostate cancer were evaluated. TGG5 was evaluated according to the International Society of Urological Pathology criterion. Cox hazard regression was used to evaluate the prognostic significance of prostate-specific antigen and pathological features in RARP specimens. RESULTS: Of the 600 RARP specimens, 92 (15%) had TGG5. TGG5 component was found in 30 (10%) of 287 cases with Gleason score (GS) 3 + 4, 55 (37%) of 149 cases with GS 4 + 3 and 7 (17%) of 40 cases with GS 4 + 4. There were no significant differences in pathological stage and surgical margin status between GS 3 + 4 with and without TGG5, as well as between GS 4 + 4 with and without TGG5. Of the 600 patients, 92 (15%) patients had biochemical recurrence (BCR) after surgery, with a median follow-up period of 42 (3-104) months. There were no differences in 5-year BCR-free survival rates between patients with GS 3 + 4 with and without TGG5 (92 vs. 100%, P = 0.16), as well as between patients with GS 4 + 3 with and without TGG5 (79 vs. 71%, P = 0.30). Similarly, there were no differences in 3-year BCRFS rates between patients with GS 4 + 4 with and without TGG5 (80 vs. 71%, P = 0.38). CONCLUSIONS: In our population, the presence of TGG5 in RARP specimens had no strong impact on pathological and prognostic outcomes.

Salvage radiation therapy for prostate cancer patients after prostatectomy.

OBJECTIVES: The aim of this study was to identify risk factors to predict a biochemical recurrence (BCR) in patients treated with salvage radiation therapy (SRT) after radical prostatectomy (RP). METHODS: We retrospectively reviewed 122 Japanese patients who received SRT for BCR after RP. Using uni- and multivariate Cox proportional hazard models, we identified the predictive factors of BCR after SRT. RESULTS: With a median follow-up of 61.3 months, 45.9% of the patients showed BCR after SRT, with 61.5 and 41.8% of non-BCR rates at the second and fifth years. Univariate proportional hazards analysis demonstrated that extraprostatic disease (P = 0.029), seminal vesicle invasion (P = 0.005), microvascular invasion (P = 0.001), postoperative Gleason score (P = 0.008) and pre-SRT prostate-specific antigen (PSA) (P = 0.005) were significantly associated with BCR after SRT. However, only the presence of microvascular invasion and a higher pre-SRT PSA were significant predictors in the multivariate analysis. The non-BCR rate in the second year after SRT for 15 patients with microvascular invasion and pre-SRT PSA > 1.2 ng/ml was only 21% compared to 72.5% of 72 patients with negative microvascular invasion and a pre-SRT PSA of <1.2 ng/ml (P = 0.000031). CONCLUSIONS: While SRT is the most important secondary treatment option for patients with BCR after RP, the effectiveness of SRT may not be uniform. The combination of risk factors such as microvascular invasion in RP specimens and pre-SRT PSA may provide a better way to stratify the risk of BCR after SRT.

Prostate-specific antigen screening impacts on biochemical recurrence in patients with clinically localized prostate cancer.

OBJECTIVE: To clarify the impact of prostate-specific antigen screening on surgical outcomes of prostate cancer. METHODS: Patients who underwent radical prostatectomy were divided into two groups according to prostate-specific antigen testing opportunity (group 1, prostate-specific antigen screening; group 2, non-prostate-specific antigen screening). Perioperative clinical characteristics were compared using the Wilcoxon rank-sum and χ2 -tests. Cox proportional hazards models were used to identify independent predictors of postoperative biochemical recurrence-free survival. RESULTS: In total, 798 patients (63.2%) and 464 patients (36.8%) were categorized into groups 1 and 2, respectively. Group 2 patients were more likely to have a higher prostate-specific antigen level and age at diagnosis and larger prostate volume. Clinical T stage, percentage of positive cores and pathological Gleason score did not differ between the groups. The 5-year biochemical recurrence-free survival rate was 83.9% for group 1 and 71.0% for group 2 (P < 0.001). On multivariate analysis, prostate-specific antigen testing opportunity (hazard ratio 2.530; P < 0.001) was an independent predictive factor for biochemical recurrence after surgery, as well as pathological T stage, pathological Gleason score, positive surgical margin and lymphovascular invasion. Additional analyses showed that prostate-specific antigen screening had a greater impact on biochemical recurrence in a younger patients, patients with a high prostate-specific antigen level, large prostate volume and D'Amico high risk, and patients meeting the exclusion criteria of the Prostate Cancer Research International Active Surveillance study. CONCLUSIONS: Detection by screening results in favorable outcomes after surgery. Prostate-specific antigen screening might contribute to reducing biochemical recurrence in patients with localized prostate cancer.

Generation and characterization of a potent fully human monoclonal antibody against the interleukin-23 receptor.

Interleukin (IL)-12 and IL-23 share a common subunit (p40) and function in T-helper (Th) 1 and Th17 immunity, respectively. Anti-IL-12/23p40 and specific anti-IL-23 antibodies are currently in clinical use for psoriasis and undergoing trials for autoimmune diseases. Since expression levels of the IL-23 receptor are likely to be much lower than those of IL-23, an anti-IL-23 receptor antibody might offer greater promise in inhibiting the IL-23-IL-17 pathways involved in inflammatory disorders. To our knowledge, no anti-IL-23 receptor antibody has been trialed in clinical studies to date. This study describes the generation and characterization of AS2762900-00, a fully human monoclonal antibody against the IL-23 receptor. AS2762900-00 bound both human and cynomolgus monkey IL-23 receptors. AS2762900-00 showed potent inhibitory effects on IL-23-induced Kit-225 cell proliferation compared to the existing anti-IL-12/23p40 antibody, ustekinumab. In a single dose administration pharmacodynamics study in cynomolgus monkeys, 1 mg/kg of AS2762900-00 significantly inhibited (> 85%) IL-23-induced STAT3 phosphorylation in blood for up to 84 days. Therefore, AS2762900-00 represents a potent novel IL-23-IL-17 pathway inhibitor with the potential to be developed into a new therapy for the treatment of autoimmune diseases.

No clinical significance of the time interval between biopsy and robotic-assisted radical prostatectomy for patients with clinically localized prostate cancer on biochemical recurrence: a propensity score matching analysis.

PURPOSE: To investigate the impact of the time interval (TI) between prostate biopsy and robot-assisted radical prostatectomy (RARP) on the risk of biochemical recurrence (BCR). METHODS: We retrospectively reviewed the medical records of 793 consecutive patients who were treated with RARP at our institution. Patients were divided into three groups, according to TI, to compare BCR-free survival (BCRFS) rates: Group 1 (n = 196), TI < 3 months; Group 2 (n = 513), 3 ≤ TI < 6 months; Group 3 (n = 84), TI ≥ 6 months. Eighty-three patients with TI ≥ 6 months were matched with an equal number of patients with TI < 6 months based on propensity scores by using four preoperative factors: prostate-specific antigen (PSA), primary (pGS) and secondary (sGS) Gleason score and positive prostate biopsy. RESULTS: The 5-year BCRFS rates for TI Groups 1, 2, and 3 were 76%, 80.7% and 82.6% (P = 0.99), respectively. The multivariate analysis revealed that PSA, pGS, sGS and a positive prostate biopsy were independent preoperative risk factors for BCR. The propensity adjusted 5-year BCRFS for patients with TI ≥ 6 months was 84.0%. This was not worse than that of patients with TI < 6 months (71.0%, P = 0.18). CONCLUSIONS: In our cohorts, a delay in the time from biopsy to RARP did not significantly affect recurrence. Therefore, hasty treatment decisions are unnecessary for at least 6 months after diagnosis of early prostate cancer.

Accessibility to surgical robot technology and prostate-cancer patient behavior for prostatectomy.

BACKGROUND: To examine how surgical robot emergence affects prostate-cancer patient behavior in seeking radical prostatectomy focusing on geographical accessibility. METHODS: In Japan, robotic surgery was approved in April 2012. Based on data in the Japanese Diagnosis Procedure Combination database between April 2012 and March 2014, distance to nearest surgical robot and interval days to radical prostatectomy (divided by mean interval in 2011: % interval days to radical prostatectomy) were calculated for individual radical prostatectomy cases at non-robotic hospitals. Caseload changes regarding distance to nearest surgical robot and robot introduction were investigated. Change in % interval days to radical prostatectomy was evaluated by multivariate analysis including distance to nearest surgical robot, age, comorbidity, hospital volume, operation type, hospital academic status, bed volume and temporal progress. RESULTS: % Interval days to radical prostatectomy became wider for distance to nearest surgical robot <30 km. When a surgical robot emerged within 30 and 10 km, the prostatectomy caseload in non-robot hospitals reduced by 13 and 18% within 6 months, respectively, while the robot hospitals gained +101% caseload (P < 0.01 for all) Multivariate analyses including 9759 open and 5052 non-robotic minimally invasive radical prostatectomies in 483 non-robot hospitals revealed a significant inverse association between distance to nearest surgical robot and % interval days to radical prostatectomy (B = -17.3% for distance to nearest surgical robot ≥30 km and -11.7% for 10-30 km versus distance to nearest surgical robot <10 km), while younger age, high-volume hospital, open-prostatectomy provider and temporal progress were other significant factors related to % interval days to radical prostatectomy widening (P < 0.05 for all). CONCLUSIONS: Robotic surgery accessibility within 30 km would make patients less likely select conventional surgery. The nearer a robot was, the faster the caseload reduction was.

Clinical significance of the prostate-specific antigen doubling time prior to and following radical prostatectomy to predict the outcome of prostate cancer.

With the advent of serum prostate-specific antigen (PSA), a larger number of prostate cancers in the early phase have been successfully detected. Although decisions to perform prostate biopsies are routinely based on PSA levels, the PSA level is easily influenced by benign prostatic hyperplasia, with poor specificity. Therefore, the aim of the present study was to assess the clinical significance of prostate-specific antigen doubling time (PSADT) prior to and following radical prostatectomy. In total, 488 patients with T1c-3N0M0 prostate cancer who underwent radical prostatectomy were included. Preoperative and postoperative PSADT were retrospectively correlated with pathological and clinical outcomes. Preoperative PSADT was measured in 204 of the 488 patients. In total, 16 out of 20 patients with a preoperative PSADT of >24 months had a cancer confined to the prostate compared with 105 of 184 patients with a PSADT of <24 months. The PSA non-recurrence rate at 5 years for patients with a preoperative PSADT of >24 months was significantly better compared with those with a preoperative PSADT of <24 months (P=0.011). Patients with a PSADT of >24 months and stable PSADT were associated with PSA recurrence following surgery, based on multivariate analysis. Postoperative PSADT was measured in 51 of 111 patients with PSA failure following surgery. Pathologically, 7 of 8 patients with a post-PSADT of >24 months had a cancer confined to the prostate compared with 14 of 43 patients with a post-PSADT of <24 months. These results suggest that patients with longer preoperative PSADTs appeared to have a favorable pathological result and a higher PSA non-recurrence rate compared with those with shorter preoperative PSADTs. A longer postoperative PSADT may facilitate the observation of patients with PSA recurrence without immediate secondary treatments.

Development of a Nomogram for Predicting Severe Neutropenia Associated With Docetaxel-Based Chemotherapy in Patients With Castration-Resistant Prostate Cancer.

BACKGROUND: Neutropenia is a major adverse event of docetaxel-based chemotherapy. The present study was undertaken to evaluate the incidence of neutropenia and to develop a nomogram for predicting Grade 4 neutropenia during the first cycle of docetaxel-based chemotherapy in patients with castration-resistant prostate cancer (CRPC). PATIENTS AND METHODS: This study included 112 patients with CRPC treated with docetaxel-based systemic chemotherapy. We evaluated the incidence and risk factors for Grade 4 neutropenia in the first cycle of chemotherapy. RESULTS: Sixty-two of 112 patients (55.4%) developed Grade 4 neutropenia in the first cycle of docetaxel-based chemotherapy. There were significant differences in age, baseline white blood cell count, and baseline neutrophil count between patients with non-Grade 4 neutropenia and those with Grade 4 neutropenia in univariate analyses. The serum prostate-specific antigen level, hemoglobin level, creatinine, albumin, Eastern Cooperative Oncology Group performance status, metastatic sites, extent of disease, and history of external beam radiotherapy to the prostate were not significantly different between the 2 groups. Multivariate logistic regression analysis showed that age (odds ratio [OR], 1.08; P = .019) and baseline neutrophil counts (OR, 0.79; P = .045) were significant independent risk factors for severe neutropenia. A nomogram and a calibration plot on the basis of these results were developed from a multivariate logistic regression analysis to predict the probability of Grade 4 neutropenia. CONCLUSION: Age and baseline neutrophil counts were significant independent risk factors for Grade 4 neutropenia. The nomogram to predict it provides useful information for the management of patients with CRPC treated with docetaxel chemotherapy.

Clinical significance of preoperative renal function and gross hematuria for intravesical recurrence after radical nephroureterectomy for upper tract urothelial carcinoma.

OBJECTIVES: To investigate the predictive values of perioperative factors and to develop a nomogram for intravesical recurrence after radical nephroureterectomy in patients with upper urinary tract urothelial carcinoma. METHODS: A retrospective analysis of 144 patients who underwent radical nephroureterectomy from 1996 to 2014 was carried out. The actuarial probabilities of the intravesical recurrence-free survival rate were calculated using the Kaplan-Meier method. Prognostic indicators for intravesical recurrence were identified using competing-risks regression analyses. RESULTS: Intravesical recurrence occurred in 63 patients during the follow-up period. The intravesical recurrence-free survival rates at 1, 3, and 5 years were 65.7%, 50.6% and 47.1%, respectively. In univariate analysis, the presence of gross hematuria (P = 0.028) and the preoperative serum creatinine level (P = 0.033) were significantly associated with intravesical recurrence. In multivariate analysis, the presence of gross hematuria (subdistribution hazard ratio 2.03, 95% CI 1.145-3.496; P = 0.013) and the preoperative serum creatinine level (subdistribution hazard ratio 3.15, 95% CI 1.161-3.534; P = 0.021) were independent predictors for intravesical recurrence after radical nephroureterectomy. Accordingly, a nomogram based on the model was developed. The concordance index of this model was 0.632. CONCLUSION: The presence of gross hematuria and preoperative serum creatinine levels seem to be independent predictors for intravesical recurrence after radical nephroureterectomy. Our nomogram developed based on these factors might aid in appropriate patient selection for clinical trials of novel therapeutic interventions, including administration of intravesical chemotherapy.

A Case of Primary Small-Cell Carcinoma of the Bladder.

Primary small-cell carcinoma arising from the bladder (SmCCB) is uncommon. It differs from urothelial carcinoma (UC), the most common type of bladder cancer, with respect to its cell of origin, biology, and prognosis. Biologically, prostatic SmCCB is much more aggressive than UC, and the prognosis for cases with distant metastasis is especially poor. We report here a case of primary SmCCB (cT3bN1M0) treated with radical cystectomy.

Sarcopenia as a Novel Preoperative Prognostic Predictor for Survival in Patients with Bladder Cancer Undergoing Radical Cystectomy.

PURPOSE: To investigate the prognostic significance of sarcopenia on long-term outcomes in patients with bladder cancer after radical cystectomy (RC). METHODS: We retrospectively reviewed 136 patients undergoing RC for urothelial carcinoma at our institution. Prognostic impact of the preoperative clinical, laboratory, and radiologic parameters were evaluated by Cox proportional hazard model analyses, and a nomogram was developed to predict cancer-specific survival (CSS) after RC. RESULTS: The mean follow-up was 46.7 months. Patients with sarcopenia had a significantly shorter CSS than those without sarcopenia. On univariate Cox analysis, clinical T stage, histology of transurethral resection of bladder tumor (TURBT) specimen, pretreatment hemoglobin, pretreatment neutrophil-to-lymphocyte ratio (NLR), pretreatment serum C-reactive protein level, pretreatment serum albumin level, presence of hydronephrosis, and presence of sarcopenia were associated with significantly worse CSS. On multivariate Cox stepwise analysis, sarcopenia (hazard rate [HR] = 2.3, p = 0.015), clinical T stage (cT4: HR = 5.3; p = 0.0096), presence of hydronephrosis (HR = 2.0; p = 0.033), histology of TURBT specimen (HR = 2.2, p = 0.044), and NLR (HR = 1.3; p = 0.0048) were significant independent predictors of an unfavorable prognosis Based on the results of the multivariate analysis, we developed a nomogram to predict 1-, 3-, and 5-year CSS after RC. CONCLUSIONS: Sarcopenia, clinical T stage, presence of hydronephrosis, histology of TURBT specimen, and NLR are novel preoperative prognostic factors even after adjustment for other known preoperative predictors in patients undergoing RC for bladder cancer.

Association between preoperative serum total cholesterol level and biochemical recurrence in prostate cancer patients who underwent radical prostatectomy.

The aim of this study was to investigate the association between serum total cholesterol (TC) level and biochemical recurrence (BCR) following radical prostatectomy (RP). The study included 562 patients with T1-3N0M0 prostate cancer, who underwent RP at our institution between 2002 and 2010. No patients received neoadjuvant and/or adjuvant therapy. The associations between preoperative TC level, clinicopathological factors and BCR were assessed using univariate and multivariate analyses. During follow-up (mean, 54.0 months), 168 patients (168/562, 29.9%) experienced BCR, with a 5-year BCR-free rate of 67.2%. Of the clinicopathological characteristics investigated, statin use and lymphovascular invasion (LVI) status were associated with lower TC level (P=0.003 and P=0.014, respectively). In the univariate analysis, a higher serum prostate-specific antigen (PSA) level at diagnosis, extracapsular extension, positive surgical margin, seminal vesicle invasion, LVI, perineural invasion, higher Gleason score (GS ≥8) based on the RP specimen, increased body mass index, and low preoperative TC level, were significantly associated with BCR. In the multivariate analysis, the TC level was an independent predictor of BCR (hazard ratio = 0.925 per 10 mg/dl; 95% confidence interval: 0.879-0.973; P=0.003), as was the serum PSA level, extracapsular extension, positive surgical margin and the GS. Low preoperative serum TC levels were associated with an increased risk of BCR among prostate cancer patients who underwent RP. Our findings suggest that the preoperative serum TC level may provide important clinical information that may prove to be useful in patient counseling.

Is scintigraphy necessary to detect migration of 125I seeds after brachytherapy for early prostate cancer?

BACKGROUND: We investigated whether scintigraphy was superior to radiography for detecting migrated seeds after brachytherapy for prostate cancer. METHODS: We studied 57 patients with early prostate cancer who were treated with free (125)I transperineal brachytherapy. Scintigraphy was used to detect seed migration on postoperative day (POD) 1, radiography was used on POD 2, and both tests were used on POD 30. RESULTS: The total number of implanted seeds in this study was 3,753 in 57 patients. Overall, there were 19 seed migrations in 12 patients. On POD 1, there were 4 seed migrations in 4 patients that were detected by scintigraphy. On POD 2, there were 10 seed migrations in 9 patients that were detected by radiography. On POD 30, 17 seed migrations were detected in 10 patients by radiography and 18 seeds migrations were detected by scintigraphy. However, 1 seed migration which was located outside of the detectable range of radiography was detected only by scintigraphy. CONCLUSIONS: Both scintigraphy and radiography have similar abilities to detect migrated seeds 1 month after (125)I brachytherapy for prostate cancer. While both tests have advantages and disadvantages, it is reasonable to only use radiography if scintigraphy is not available.

Preoperative predictive factors and further risk stratification of biochemical recurrence in clinically localized high-risk prostate cancer.

BACKGROUND: To identify preoperative predictive factors for biochemical recurrence (BCR) and to further stratify its risk in high-risk localized prostate cancer patients receiving radical prostatectomy (RP). METHODS: Subjects included 195 high-risk prostate cancer patients undergoing RP from 2000 to 2012. RP consisted of retropubic radical prostatectomy and robot-assisted radical prostatectomy, involving 84 cases and 111 cases, respectively. BCR was defined as a prostate serum antigen (PSA) level ≥0.2 ng/mL. BCR-free survival (BCRFS) was calculated using the Kaplan-Meier method. Preoperative predictors of BCR were assessed with Cox's proportional hazard regression analysis. RESULTS: Eighty-nine patients (45.6 %) experienced recurrence. BCRFS rates 3 and 5 years after RP were 58 and 50 %, respectively. Prostate volume, transition zone volume, and Gleason score were not significantly associated with BCR. Patients with higher preoperative PSA, PSA density (PSAD), PSA density of the transition zone, percentage of positive cores (PPC), and PPC from the dominant side showed significantly lower BCRFS. The PPC from the dominant side and PSAD were significant independent prognostic factors for BCR. Using these variables, the hazard ratio of BCR could be calculated and patients stratified into three risk groups. The 5-year BCRFS rates for Groups 1, 2, and 3 were 64.9 %, 48.1 %, and 21.3 %, respectively. CONCLUSIONS: Patients with high-risk localized prostate cancer as currently defined do not have uniformly poor prognosis after RP. PPC from the dominant side and PSAD are significant predictors of BCR. These factors can identify high-risk patients with very poor prognosis.