Randomised phase III study of neoadjuvant chemotherapy with methotrexate, doxorubicin, vinblastine and cisplatin followed by radical cystectomy compared with radical cystectomy alone for muscle-invasive bladder cancer: Japan Clinical Oncology Group Study JCOG0209.

BACKGROUND: This study aimed to determine the clinical benefit of neoadjuvant methotrexate, doxorubicin, vinblastine, and cisplatin (MVAC) in patients with muscle-invasive bladder cancer (MIBC) treated with radical cystectomy. PATIENTS AND METHODS: Patients with MIBC (T2-4aN0M0) were randomised to receive two cycles of neoadjuvant MVAC followed by radical cystectomy (NAC arm) or radical cystectomy alone (RC arm). The primary end point was overall survival (OS). Secondary end points were progression-free survival, surgery-related complications, adverse events during chemotherapy, proportion with no residual tumour in the cystectomy specimens, and quality of life. To detect an improvement in 5-year OS from 45% in the RC arm to 57% in the NAC arm with 80% power, 176 events were required per arm. RESULTS: Patients (N = 130) were randomly assigned to the RC arm (N = 66) and the NAC arm (N = 64). The patient registration was terminated before reaching the initially planned number of patients because of slow accrual. At the second interim analysis just after the early stoppage of patient accrual, the Data and Safety Monitoring Committee recommended early publication of the results because the trial did not have enough power to draw a confirmatory conclusion. OS of the NAC arm was better than that of the RC arm, although the difference was not statistically significant [hazard ratio 0.65, multiplicity adjusted 99.99% confidence interval 0.19-2.18, one-sided P = 0.07]. In the NAC arm and the RC arm, 34% and 9% of the patients had pT0, respectively (P < 0.01). In subgroup analyses, OS in almost all subgroups was in favour of NAC. CONCLUSIONS: This trial showed a significantly increased pT0 proportion and favourable OS of patients who received neoadjuvant MVAC. NAC with MVAC can still be considered promising as a standard treatment. UMIN CLINICAL TRIALS REGISTRY IDENTIFIER: C000000093.

Molecular followup of newly diagnosed bladder cancer using urine samples.

PURPOSE: Patients with superficial bladder cancer can be treated with transurethral resection. However, 50% to 70% of them have intravesical recurrence after transurethral resection and muscle invasive disease develops in 10% to 20%, which is eventually indicated for radical cystectomy. Therefore, reliable predictors of intravesical recurrence are required for management of superficial bladder cancer. We investigated whether detection of the loss of heterozygosity in urine samples would be available as a sensitive diagnostic modality for recurrence of bladder cancer. MATERIALS AND METHODS: Urine samples, cancer tissue and peripheral blood lymphocytes were obtained from 37 patients with newly diagnosed bladder cancer, and analyzed for the loss of heterozygosity on chromosomes 9 and 17p by single strand DNA conformation polymorphism analysis. RESULTS: Chromosomal loss was detected on 24 (65%) cancer tissues and 26 (70%) urine samples. The loss of heterozygosity on chromosome 17p was detected in 19 (51%) urine samples, mostly in cancers with higher grades and/or stages. During postoperative followup of 24 patients with superficial bladder cancer who had undergone transurethral resection, intravesical recurrence did not develop in 9 of 10 without chromosomal aberrations in urine samples. In contrast, intravesical recurrence developed in 11 of 14 patients who had a loss of heterozygosity in urine samples. This loss showed a significant correlation with the intravesical disease-free period (p = 0.004). Multivariate analysis revealed that the loss of heterozygosity in urine samples was a significant predictor of intravesical recurrence. CONCLUSIONS: Detection of the loss of heterozygosity in urine samples is available as a sensitive marker for predicting intravesical recurrence of superficial bladder cancer.

Induction of tumor specific cytotoxic T lymphocytes in prostate cancer using prostatic acid phosphatase derived HLA-A2402 binding peptide.

PURPOSE: Human prostatic acid phosphatase is a prostate specific differentiation antigen. Prostatic acid phosphatase levels increase in the serum of patients with prostate cancer and its peptide from positions 299 to 307 (PAP 299-307) is recognized by HLA-A2 restricted cytotoxic T lymphocytes. We investigated whether HLA-A2402 binding prostatic acid phosphatase derived peptides induce HLA-A2402 restricted, tumor specific cytotoxic T lymphocytes from the peripheral blood mononuclear cells of patients with prostate cancer. MATERIALS AND METHODS: Peptide binding activity was measured with RMA-S-A*A2402 cell lines and flow cytometry. Cytotoxic T-lymphocyte activity of the peripheral blood mononuclear cells of patients with prostate cancer and healthy donors was measured by interferon-gamma and (51)creatinine release assays. Prostatic acid phosphatase expression in the tumor cell lines at the messenger RNA and protein levels was investigated by reverse transcriptase-polymerase chain reaction and immunohistochemical analysis, respectively. RESULTS: An HLA-A2402 binding, prostatic acid phosphatase derived peptide consisting of the prostatic acid phosphatase amino acid sequence from positions 213 to 221 (PAP 213-221, LYCESVHNF) showed the ability to induce HLA-A2402 restricted and tumor specific cytotoxic T lymphocytes, which are cytoxic to prostatic acid phosphatase positive tumor cells from the peripheral blood mononuclear cells of patients with prostate cancer. CONCLUSIONS: PAP 213-221 may be appropriate as a cancer vaccine for specific immunotherapy in patients with HLA-A2402 positive prostate cancer.

[The role of tumor markers in the treatment of germ cell tumor].

Alfa fetoprotein (AFP), human chorionic gonadotropin (HCG), beta HCG and lactate dehydrogenase (LDH) are powerful markers of germ cell tumors. The role of tumor markers is very important in the diagnosis, treatment and follow-up of germ cell tumors, respectively. We can often deduce the histological typing of germ cell tumors by tumor marker elevation before surgery. Tumor markers also frequently provide clues as to outcome in individual cases before treatment. The half-life of tumor markers during chemotherapy indicate the effect of the treatment. The optimal regimen of chemotherapy should therefore be selected based on the half-life of tumor markers. Normalized tumor markers designate the phase of discussion on surgical indications. Determination of tumor markers is important in following patients after treatment of germ cell tumors. The elevation of serum tumor markers denotes recurrence and is often the first sign of treatment failure.

Signet-ring cell carcinoma of the urinary bladder associated with transitional cell carcinoma of the right ureter.

We report on a case of a 72-year-old male with vesical signet-ring cell carcinoma containing a transitional cell carcinoma (TCC) component. It was associated with pure TCC of the right ureter. No other microscopic changes were found in the bladder. The pathogenesis of this signet-ring cell carcinoma is described.

The external radiotherapy with three-dimensional conformal boost after the neoadjuvant androgen suppression for patients with locally advanced prostatic carcinoma.

PURPOSE: To analyze the results in patients with locally advanced prostatic carcinoma treated by hormonal therapy followed by external radiotherapy using three-dimensional conformal radiation therapy (3D-CRT) boost. METHODS AND MATERIALS: From 1987 to 1995, 46 patients with histologically proven locally advanced adenocarcinoma of the prostate were treated with 3D-CRT at the National Cancer Center Hospital, Tokyo. The neoadjuvant androgen suppression started immediately after the diagnosis followed by radical radiation therapy, according to the prospective protocol. They were treated with photons of 6-14 MV for wide fields and the boost, of which a multiple-leaf collimator of 2-cm width was available. The boosted dose was delivered with the rotational 3D-CRT, after the delivery of whole pelvis 4-field box from a dose of 40-46 Gy up to 66 Gy. The planning target volume encompassed 1 cm outside throughout the clinical target volume, and the prostate and the seminal vesicles were included in the boost field. RESULTS: The 3D-CRT boost treatment completed as planned in all 46 patients. The median follow-up for all the patients was 60 months (range, 5-120 months). Nineteen of 46 patients died. Of these, 11 patients died of the intercurrent diseases. For all 46 patients, the 5- and 8-year overall survival rates were 61.3% and 42.4%, and the 5- and 8-year cause-specific survival rates were 82.4% and 64.4%, respectively. The prostate-specific antigen (PSA) relapse-free rates for 5- and 8-year were 64.6% and 52.5%, and the clinical local control rates for 5 and 8 years were 75.3% and 69.9%, respectively. The preradiation therapy PSA and the Gleason score were the factors that significantly associated with PSA relapse-free survival. Sixteen of 46 patients (35%) showed at least one form of late toxicities. Of these, 3 patients experienced late complications of Grade 3 (urinary, 2, proctitis, 1). CONCLUSION: The treatment results were fairly good and were consistent with those in Western countries, indicating that this study shows the preliminary status of 3D-CRT for the locally advanced prostate cancer in Japan. Preradiation therapy PSA seems to be a significant predictor of PSA relapse-free survival (p = 0.004) after neoadjuvant androgen suppression.

Clinical significance of nonpalpable prostate cancer with favorable biopsy features in Japanese men.

OBJECTIVE: To assess the clinical significance of nonpalpable localized prostate cancers with relatively favorable six sextant biopsy features in Japanese men. PATIENTS AND METHODS: 136 nonpalpable prostate cancers of which biopsy features confined to (1) a Gleason score of 6 or less, (2) one or two positive cores per six sextant cores, and (3) 50% or less involvement of any positive core were collected. The Gleason score, tumor extension, and cancer volume were compared with preoperative serum PSA and PSA density for the patients who underwent radical prostatectomy. PSA doubling time was measured for the patients who were treated expectantly. RESULTS: Treatments chosen for 136 patients with favorable biopsy features were radical prostatectomy alone for 48 and with preoperative androgen deprivation for 30, radiation to the prostate for 12, androgen deprivation therapy for 21, and watchful waiting for 25. Of 48 patients who underwent radical prostatectomy without androgen deprivation therapy, 25% had nonorgan-confined cancers. Seven cancers (14.6%) were Gleason score of 7, but no cancers were 8 or greater. Among 42 prostatectomy specimens for which cancer volume was measured, 22 (52.4%) had cancer volume >0.5 cm(3). Pretreatment serum PSA levels were correlated neither with the Gleason score, tumor extension nor cancer volume. There was only one nonorgan-confined cancer in the 23 cancers for which PSA density was <0.2 ng/ml/g. The ability of PSA density to predict cancer volume <0. 5 cm(3) was 0.61 using a cut-off of 0.2 ng/ml/g. Of the 25 patients treated expectantly, the PSA doubling time was less than 2 years for 3 patients, while it was stable or fluctuated for 13. CONCLUSIONS: Tumor extension can be predicted based on PSA density in nonpalpable prostate cancer with favorable biopsy features, but predictability of cancer volume based on PSA or PSA density is not satisfactorily high. New parameters or biomarkers that complement needle biopsy findings are needed to predict clinical significance of T1c prostate cancer with favorable biopsy features.

Radical retropubic prostatectomy: time trends, morbidity and mortality in Japan.

OBJECTIVES: To assess the time trends, morbidity and mortality of contemporary anatomical radical retropubic prostatectomy (RRP) in a multi-institutional study in Japan, where RRP has become more popular in the last decade. PATIENTS AND METHODS: Between January 1991 and August 1998, 638 patients underwent RRP at seven urological centres in Japan. Major complications (within 30 days of surgery) and the 30-day mortality were reviewed retrospectively. Of the patients, 12.9% were < 60 years old, 56.3% were 60-69 years old and 30.9% were >/= 70 years old (median age 67). Results The number of RRPs increased markedly, by more than sevenfold, from 1991-92 to 1996-97, mainly because there were more patients undergoing RRP in their sixth decade. The contribution of T1c disease increased in absolute and relative terms, from 13.9% in 1991-92 to 37.9% in 1997-98. Over time, the mean blood loss and the allogeneic transfusion rate decreased steadily. There was a trend toward more favourable outcomes for pathological variables (an increased percentage of organ-confined disease, decreased margin positivity and a decreased incidence of positive lymph node metastasis). The most common complications were wound-related (7.5%), or anastomotic leakage (4.1%). Major cardiopulmonary complications occurred in only two patients (0.31%, both pulmonary embolisms). One patient died from cerebral haemorrhage within 30 days of surgery, giving a mortality rate of 0.16%. CONCLUSION: s This study indicates a trend towards selecting patients most likely to benefit from RRP. Although the procedure is technically demanding, it can have an acceptably low rate of early complications, little mortality and need for allogeneic transfusion. The assessment of morbidity suggests a lower incidence of catastrophic thrombo-embolic and cardiac complications in Japanese patients than in Western men. The present data may be useful in decision-analysis models evaluating the role of therapy for Asian men with early-stage prostate cancer.

Prevention and treatment of urothelial premalignant and malignant lesions.

Bladder cancer is believed to develop through reversible premalignant stages followed by irreversible steps, and ending in invasive cancer giving rise to distant metastases. Because of the variation in the clinical course it has also been suggested that different forms of cancer develop along different molecular pathways leading to tumor presentations of various malignant potential. Today we treat and prognosticate bladder cancer on the basis of clinical and histologic findings that are insufficient to assess all the biologic potential of these tumors. Understanding the pathogenesis of bladder cancer might lead to a more precise identification of particular tumors with regard to clinical aggressiveness, resulting in individualized strategies for treatment and prophylaxis. Bladder cancer is seldom diagnosed in its preclinical stage, it is instead detected at cystoscopy and virtually never recognized as an incidental finding on autopsy. Therefore its "natural history" largely reflects that of "treated" disease. The true incidence of premalignant and malignant epithelial changes is not known. Incidences of hyperplasia and dysplasia of approximately 10% and approximately 5%, respectively and only occasional findings of cancer itself were reported in two autopsy series. Urothelial dysplasia is generally believed to be premalignant and a putative precursor of invasive cancer but unfortunately there has been a lack of standardization in terms of terminology and diagnosis. There is also a need for an agreed definition of the boundary between premalignancy, i.e. urothelial changes that have some but not all the features of carcinoma in situ, and malignancy, especially when considering potentially harmful treatments to prevent this transition. Most new diagnostic tools available and being tested today compare new detection techniques with traditional methods such as cytology or conventional histology of malignant rather than premalignant changes. There is probably also a short preclinical latency, as implied by the incidental findings of bladder cancer at autopsy, which makes it necessary to define how and when to promote early detection and treatment. Future studies therefore have to concentrate on methods for early detection of disease as well as characterization of host susceptibility, evaluation of exposure to carcinogens and potential effects of preventive measures. It is also likely that the improved tools of molecular prognostication will allow us to design trials more precisely in order to tailor therapeutic strategies.

Use of pretreatment prostate-specific antigen doubling time to predict outcome after radical prostatectomy.

The objective of this study was to better understand the implications of the rate of prostate-specific antigen (PSA) changes in prostate carcinoma. We retrospectively calculated PSA doubling times prior to surgery in 62 patients with prostate carcinoma. The calculated values were compared with final pathologic findings and with rates of PSA failure after surgery. PSA values increased during the period of observation in 82.3% of the patients, whereas 17.7% had levels that remained stable. The median calculated PSA doubling time in those with increasing levels was 25.8 months, with doubling times 36 months (P=0.02). Biochemical failure was more common in patients with rapid PSA doubling times (P<0.01). The calculated PSA doubling time prior to radical surgery is significantly associated with the final pathologic findings. Early PSA failure is more common in patients with rapid PSA doubling times prior to radical surgery. Prostate Cancer and Prostatic Diseases (2000) 3, 269-274

Long-term results of a randomized trial for the treatment of Stages B2 and C prostate cancer: radical prostatectomy versus external beam radiation therapy with a common endocrine therapy in both modalities.

OBJECTIVES: To improve the treatment of locally advanced prostate cancer (Stages B2 and C), a prospective randomized trial was conducted to compare radical prostatectomy versus external beam radiotherapy with the combination of endocrine therapy in both modalities. METHODS: One hundred patients were enrolled and 95 were evaluated. Forty-six patients underwent radical prostatectomy with pelvic lymph node dissection, and 49 were treated with radiation by linear accelerator with 40 to 50 Gy to the whole pelvis and a 20-Gy boost to the prostatic area. For all patients, endocrine therapy was initiated 8 weeks before surgery or radiation, and continued thereafter. The living patients were asked to respond to a quality-of-life questionnaire. RESULTS: The follow-up period ranged from 6.0 to 94.4 months (median 58.5). The progression-free and cause-specific survival rates at 5 years were 90.5% and 96.6% in the surgery group and 81.2% and 84.6% in the radiation group, respectively. The surgery group had better progression-free and cause-specific survival rates (P = 0.044 and 0.024, respectively). More patients in the surgery group complained of urinary incontinence. The questionnaire revealed that quality of life was less disturbed in the radiation group. CONCLUSIONS: Radical prostatectomy combined with endocrine therapy may contribute to the survival benefit of patients with locally advanced prostate cancer. External beam radiotherapy in combination with endocrine therapy can be used in selected patients because of its low morbidity.

[Assessment of QOL and survival for patients undergoing radical cystectomy or bladder preservation for invasive bladder cancer].

PURPOSE: In this study, we have retrospectively compared patient backgrounds, prognosis and QOL (quality of life) in patients with invasive bladder cancer treated by radical cystectomy or by bladder preservation. PATIENTS AND METHODS: This study enrolled recent 30 cases from each institutions, totally 120 cases from four institutions. All patients were diagnosed with invasive bladder cancer in stage T 2 or T 3, N 0, M 0. The patients planned for preserving the bladder were treated with a combination of intra-arterial chemotherapy and radiation as an induction therapy. The questionnaire used to assess QOL was the EORTC QLQ-C 30 (Japanese-language edition). RESULTS: Radical cystectomy was selected as the initial treatment in 60 cases (the planned radical cystectomy group). Bladder preservation was planned but the presence of residual tumors after induction therapy underwent radical cystectomy in 18 cases (the preservation-radical cystectomy group). Bladder preservation was achieved in 42 cases (the preservation group). In a comparison of background factors, histologically grade 3 tumor and cases with histology other than transitional cell carcinoma, were significantly common in the planned radical cystectomy group. Because this study is not an randomized test, it is difficult to compare the outcomes between the patients treated by radical cystectomy or by bladder preservation. However, it is indicated that the candidates for bladder preservation therapy exist among the patients with T 2 or T 3, N 0, M 0 bladder cancer. Quality of life, as evaluated from global QL and from physical, cognitive, and emotional function, tended to be better in the patients with their bladder, although no difference was noted among the groups with regard to life role or social function. Symptoms such as sleep disturbance and diarrhea were common in the radical cystectomy groups, and financial impact, constipation, appetite loss, and dyspnea also tended to more frequently affect patients in these groups. CONCLUSION: Our results indicate that bladder preservation treatment using an induction therapy is one of option of the treatment for clinically T 2 or T 3, N 0, M 0 bladder cancer. We need a prospective randomized study with a long-term follow-up to elucidate true candidates for this treatment.

Alveolar architecture of clear cell renal carcinomas (< or = 5.0 cm) show high attenuation on dynamic CT scanning.

BACKGROUND: To establish the correlation between tumor appearance on CT and tumor histology in renal cell carcinomas. METHODS: The density and attenuation patterns of 96 renal cell carcinomas, each < or = 5 cm in greatest diameter, were studied by non-enhanced CT and early and late after bolus injection of contrast medium using dynamic CT. The density and attenuation patterns and pathological maps of each tumor were individually correlated. RESULTS: High attenuated areas were present in 72 of the 96 tumors on early enhanced dynamic CT scanning. All 72 high attenuated areas were of the clear cell renal cell carcinoma and had alveolar architecture. The remaining 24 tumors that did not demonstrate high attenuated foci on early enhanced scanning included three clear cell, nine granular cell, six papillary, five chromophobe and one collecting duct type. With respect to tumor architecture, all clear cell tumors of alveolar architecture demonstrated high attenuation on early enhanced scanning. CONCLUSION: Clear cell renal cell carcinomas of alveolar architecture show high attenuation on early enhanced dynamic CT scanning. A larger number of patients are indispensable to obtaining clear results. However, these findings seem to be an important clue to the diagnosis of renal cell carcinomas as having an alveolar structure.

Urinary incontinence after non-nerve-sparing radical prostatectomy with neoadjuvant androgen deprivation.

OBJECTIVES: The impact of non-nerve-sparing retropubic radical prostatectomy (RRP) for prostate cancer combined with neoadjuvant androgen deprivation on urinary control is not well documented. We examined the incidence and severity of urinary incontinence after such therapy and determined the etiologic factors causing this complication. METHODS: We examined the postoperative continence status of 104 consecutive patients admitted to the National Cancer Center Hospital who underwent RRP with wide resection of the pelvic nerves after neoadjuvant androgen deprivation. Incontinence was scored according to the number of pads used daily by the patient for urinary leakage. The severity of incontinence was analyzed according to patient age, weight of resected specimen, status of cancer stage, duration of neoadjuvant androgen blockade therapy, preoperative length of membranous urethra, and duration of urethral catheterization after surgery. We also measured the configuration and diameter of the reconstructed bladder neck by retrograde cystourethrography. RESULTS: In 104 patients examined, the percentage of patients who became dry postoperatively was 22% at 1 month, 47% at 3 months, 69% at 6 months, and 78% at 1 year. Of 81 patients who became dry postoperatively at any interval, 22 (27%) became continent within 1 month of RRP, 49 (61 %) were continent within 3 months, 71 (88%) became continent by 6 months, and another 10 (12%) became continent between 6 and 12 months postoperatively. Of 48 patients who were followed up for more than 1 year and for whom continence status at 1 month after surgery was available, all patients who used 1 to 2 pads per day (13 of 13) at 1 month after surgery regained continence by 1 year after surgery. However, only 62% of patients (16 of 26) who required more than 3 pads per day at 1 month after surgery became dry by 1 year after surgery. Only age (older than 70 years) and large prostate size (weight of surgical specimen more than 40 g) temporarily influenced the recovery of urinary continence after surgery. Dilation of the bladder neck evaluated by retrograde cystourethrography was prominent in severely incontinent patients in the immediate postoperative period. CONCLUSIONS: Our experience in patients who undergo non-nerve-sparing RRP after neoadjuvant androgen deprivation closely matches published surveys of patient-reported complications. Postoperative incontinence is not a major contraindication for non-nerve-sparing RRP after neoadjuvant endocrine therapy. Dilation of the bladder neck affected the recovery from incontinence, highlighting the importance of adequate reconstruction of the bladder neck.

Primary low-grade lymphoma of mucosa-associated lymphoid tissue of the urinary bladder: a case report with special reference to the use of ancillary diagnostic studies.

We report a case of primary low-grade B-cell lymphoma of the mucosa-associated lymphoid tissue (MALT) type of the urinary bladder. The patient, a 77-year-old woman, presented with a sense of urinary retention. An intravenous pyelogram and cystoscopy revealed a wide-based submucosal mass measuring 3 cm in the left wall of the urinary bladder. Histological findings of the tissue obtained by transurethral resection (TUR) showed a dense, monomorphic atypical lymphoid (centrocyte-like) infiltrate with reactive lymph follicles in the subepithelial tissue. Monocytoid and plasmacytoid features were readily evident in a population of these cells. Lymphoepithelial lesions involving the urothelium were also noticed in some areas. These features were strongly suggestive of primary low-grade lymphoma of the MALT type. The diagnosis was confirmed by immunohistochemical and flow cytometric studies, both of which showed a clear immunoglobulin restriction to lambda light chain and also by polymerase chain reaction-based assay using a formalin-fixed paraffin-embedded TUR tissue sample, which showed a clonal Ig heavy-chain gene rearrangement. Clinical staging procedures revealed that the tumor was localized in the urinary bladder. The patient has not received chemotherapy and is alive and well with no evidence of recurrence, 3 years after TUR. This case demonstrates that these ancillary tests are worth performing for confirmation of B-cell clonality in TUR tissue samples showing dense B-lymphocytic infiltration.

Preoperative predictors for organ-confined disease in Japanese patients with stage T1c prostate cancer.

BACKGROUND: In order to define the characteristics of patients with clinical stage T1c prostate cancer in Japan, clinicopathologic data obtained from patients treated by radical prostatectomy were reviewed. METHODS: Fifty-four stage T1c cancers were evaluated for tumor volume, Gleason grade, tumor location and pathologic stage from prostatectomy specimens in association with preoperative clinical parameters. RESULTS: The mean tumor volume was 3.94 mL (range, 0.07 to 33.4 mL), and 11 of the 54 tumors had a tumor volume of less than 0.5 mL. Thirty-two tumors (59%) were organ-confined, while 7 (13%) involved the seminal vesicle and/or regional lymph nodes. Multivariate logistic regression analysis of the pretreatment variables, including age, pretreatment PSA level, prostate volume, biopsy grade, and number of cancer-positive cores revealed that the serum PSA level and the number of cancer-positive biopsy cores were independent factors to predict organ-confined tumors (P = 0.036 and 0.044, respectively). For T1c cancer with less than 4 cancer-positive biopsy cores, the sensitivity and specificity for predicting organ-confined tumors were 90% and 70%, with a cut-off value of 17 ng/mL for the serum PSA level. CONCLUSION: The clinicopathologic features of T1c prostate cancer in Japanese patients were similar to those of whites reported elsewhere. Both serum PSA levels and the number of positive biopsy cores may be useful as pretreatment parameters to identify patients with the potential to benefit from radical treatment.