Identification of characteristics predictive of long-term survival with durvalumab or durvalumab plus tremelimumab in metastatic urothelial carcinoma.

BACKGROUND: This retrospective analysis of data from clinical trials in metastatic urothelial carcinoma (mUC) was conducted to determine baseline patient characteristics associated with long-term survival (LTS) following treatment with immune checkpoint inhibitors. METHODS: Data for this analysis were from patients with platinum-refractory mUC who received durvalumab or durvalumab plus tremelimumab in phase 1/2 studies. The primary outcome measure was LTS. Patients were categorised as overall survival (OS) ≥ 2 years (from first dose) or OS < 2 years. A univariable analysis assessed independent associations with LTS and multivariable logistic regression was employed including each variable with P ≤ 0.05 as covariates. RESULTS: Among 360 patients, 88 (24.4%) had OS ≥ 2 years and 272 (75.6%) had OS < 2 years. In univariable analysis, several baseline characteristics and laboratory measurements were associated with LTS including sex, ECOG PS, PD-L1 expression, prior surgery, time from initial diagnosis, lymph node-only involvement, visceral disease, haemoglobin level, absolute neutrophil count, neutrophil-lymphocyte ratio and lactate dehydrogenase level. In multivariable analysis, LTS was significantly associated with ECOG PS, PD-L1 expression, haemoglobin level and absolute neutrophil count. CONCLUSIONS: Several baseline clinical characteristics and laboratory measurements were associated with LTS for patients with platinum-refractory mUC treated with durvalumab or durvalumab plus tremelimumab.

Prognostic indicators for long term outcome following radical retropubic prostatectomy for prostate cancer involving the seminal vesicles.

Seminal vesicle involvement at the time of radical prostatectomy (RP) for prostate cancer has been equated with metastatic disease. We review our biochemical freedom from disease results following RP in patients with seminal vesicle involvement with particular attention to identifying variables that may be predictive of disease recurrence. We retrospectively reviewed our surgical database and identified patients with pT3b (2002 AJCC) prostate cancer at RP [corrected]. There were 70 cases without lymph node involvement and with available clinical follow-up identified. Any patient receiving androgen deprivation therapy, radiation therapy, or with a sustained PSA elevation greater than 0.2 ng/mL was considered a biochemical failure. Results were calculated using the Kaplan-Meier method. Mean age was 63.4 (range 45.7-79.5) years, mean preoperative PSA was 11.3 ng/mL (range 2-60), mean biopsy Gleason score was 7.2 (range 4-9), mean RP Gleason score was 7.5 (range 5-9), and median follow-up time was 61.5 months (range 2.3-160.6). Overall, 33/70 (47%) patients were without evidence of disease without further therapy. For patients with pT3bN0Mx prostate cancer, margin status, capsular invasion, and PSA were not statistically significant risk factors for disease progression. Gleason score and major Gleason grade were the only statistically significant variables that predicted disease progression. A specimen Gleason score of greater than 7 and major Gleason grades greater than 3 were associated with an increased rate of disease progression in this patient group.

A contemporary evaluation of cytoreductive nephrectomy with tumor thrombus: Morbidity and long-term survival.

BACKGROUND: Metastatic renal cell carcinoma (RCC) is an aggressive entity that frequently invades the venous system. We evaluated the morbidity and survival of patients with tumor thrombus who undergo cytoreductive nephrectomy. MATERIALS AND METHODS: We identified 56 patients from our institution's database who had a primary renal tumor in place and documented metastases at the time of surgery. We reviewed demographic and pathologic characteristics from these patients as well as complications and overall survival. RESULTS: Median age was 58 (37-77). There were 33 patients (59%) who had tumor thrombus with 21 (64%) involving the renal vein, 10 (30%) involving the infradiaphragmatic inferior vena cava (IVC), and 2 (6%) involving the supradiaphragmatic IVC. Median tumor size for thrombus patients was 12 cm (5-29). There were 8 (14.2%) who had complications, including 1 death. Thrombus patients were significantly more likely to have a complication (P = 0.008). Median survival for all patients was 10.7 months (0.3-61). There was no significant difference in overall survival between patients with and without thrombus (P = 0.76). CONCLUSIONS: Patients who undergo cytoreductive nephrectomy with a tumor thrombus have a higher rate of complications as compared to patients undergoing cytoreductive nephrectomy without tumor thrombus. The long-term survival, however, was not statistically different and thus aggressive surgery for select metastatic RCC patients is warranted.

Prostate volume and pathologic prostate cancer outcomes after radical prostatectomy.

OBJECTIVES: To more clearly elucidate the relationship between prostate volume (PV) and prostate cancer parameters. METHODS: The Urologic Oncology Database was reviewed. A total of 3460 patients had undergone radical prostatectomy from 1988 to 2006. Of these, 2600 with complete data were included in the study and were stratified by the PV: normal (0 to 40 cm(3)), moderate (40 to 80 cm(3)), or large (greater than 80 cm(3)). The prostate cancer variables were evaluated using analysis of variance. Regression models were used to determine the role of PV in Gleason sum discordance (greater than 1 unit) controlling for prostate-specific antigen level and clinical and pathologic stage. RESULTS: Of the 2600 patients, 1453 (55.2%) had a normal, 1035 (39.8%) a moderate, and 130 (5.0%) a large PV. Patients with a normal PV were more likely to have a Gleason sum greater than 6 at biopsy (46.2%) and radical retropubic prostatectomy (68.4%) compared with patients with a moderate (39.0% and 58.9%, respectively) or a large (41.5% and 57.7%, respectively) PV (P = 0.005 and P = 0.001, respectively). Patients with a normal PV had greater rates of extraprostatic extension (32.3%) and positive margins (28.2%) compared with those with a moderate (25.5% and 22.4%, respectively) or a large (23.3% and 20.3%, respectively) PV (P = 0.002 and P = 0.005, respectively). Of all 2600 patients, 55.9% had no change between the biopsy and pathologic Gleason sum, 255 (9.8%) were downgraded, and 890 (34.3%) were upgraded. Patients with a large PV had a greater rate of downgrading (16.2%) than those with a normal (8.7%) or moderate (10.5%) PV (P = 0.01). Patients upgraded had the greatest rate of pathologically advanced disease (35.3% with Stage T3 or greater, P <0.001). On multivariate regression analysis, PV (odds ratio 0.99, P = 0.005), prostate-specific antigen level (odds ratio 1.03, P <0.001), and age (odds ratio 1.03, P <0.001) were predictors of Gleason discordance +/-2. CONCLUSIONS: The results of our study have shown that patients with a large PV (greater than 80 cm(3)) are more likely to have a lower Gleason sum, locally confined and less-aggressive pathologic disease, and were more often downgraded.

Local control and long-term disease-free survival for stage D1 (T2-T4N1-N2M0) prostate cancer after radical prostatectomy in the PSA era.

OBJECTIVES: With the advent of prostate-specific antigen (PSA) screening, the number of lymph node metastases found after radical prostatectomy (RP) has been decreasing. Although it has been shown in this population that immediate adjuvant androgen deprivation therapy (ADT) improves survival compared with initiating ADT at clinical recurrence, the effect of starting ADT at biochemical recurrence is unknown. We examined a series of patients with Stage D1 (T2-T4N1-N2M0) prostate cancer discovered after RP, most of whom started ADT at biochemical recurrence. METHODS: A total of 2121 patients underwent RP and bilateral pelvic lymph node dissection from January 1990 and December 2000. Of these men, 28 had lymph node metastases (1.3%), 24 of whom had adequate follow-up data for analysis. RESULTS: No perioperative or long-term complications, such as pelvic recurrence, gross hematuria, urinary retention, or hydronephrosis, developed. With a median follow-up of 74 months, the estimated 5-year survival rate was 94%, similar to the average life expectancy of age-matched men in the United States. The 5-year biochemical disease-free survival rate was 15%. A total of 18 patients who did not start immediate ADT had an estimated 100% overall survival rate at 5 years. CONCLUSIONS: The results of our study have shown that survival for patients with Stage D1 prostate cancer after RP is excellent and equivalent to that of age-matched controls. Long-term pelvic morbidity due to primary tumor progression was prevented by RP. By waiting until PSA failure to initiate ADT, we found that a small percentage of patients (15% at 5 years) were rendered disease free with surgery alone and could avoid the side effects of ADT, with excellent overall survival maintained for those starting ADT at biochemical progression.

Intermediate-risk localized prostate cancer in the PSA era: radiotherapeutic alternatives.

OBJECTIVES: To retrospectively compare the biochemical disease-free survival (BDFS) of patients treated with standard dose external beam radiotherapy (SD-EBRT), SD-EBRT plus androgen deprivation (AD), and brachytherapy-based treatment (brachytherapy with or without EBRT with or without AD). METHODS: All 297 patients with intermediate-risk prostate cancer treated with these radiation-based treatments at our institution from August 1989 to June 2001 were included. Biochemical relapse was defined according to the American Society for Therapeutic Radiology and Oncology (ASTRO) definition, a prostate-specific antigen level of 1.5 ng/mL or greater and rising on two consecutive occasions (the "Bolla" definition), and the current prostate-specific antigen nadir plus 2 ng/mL with failure dated "at call" (the "Houston/Phoenix" definition). The number of patients treated with SD-EBRT, SD-EBRT plus AD, and brachytherapy-based treatment was 141, 84, and 72, respectively. The year of treatment was analyzed as a prognostic factor. The median follow-up was 32.3, 34.7, and 41.5 months for the ASTRO, Bolla, and Houston/Phoenix definitions, respectively. RESULTS: The brachytherapy-based treatment resulted in improved BDFS compared with SD-EBRT (ASTRO definition, 5-year BDFS rate 88% +/- 5% versus 49% +/- 5%, P <0.01; Bolla definition, 88% +/- 8% versus 49% +/- 5%, P <0.01; Houston/Phoenix definition, 81% +/- 10% versus 64% +/- 5%, P = 0.01). SD-EBRT plus AD was superior to SD-EBRT alone using the Bolla definition (5-year BDFS 76% +/- 7% versus 49% +/- 5%, P <0.01) and the Houston/Phoenix definition (85% +/- 6% versus 64% +/- 5%, P = 0.01), but not using the ASTRO definition (P = 0.17). Multivariate analysis, including prostate-specific antigen, clinical stage, Gleason score, and year of treatment, demonstrated improved biochemical outcomes for brachytherapy-based treatment versus SD-EBRT (ASTRO, P <0.01; Bolla, P <0.01; and a trend toward significance with Houston/Phoenix, P = 0.07) and for the addition of AD to SD-EBRT (Bolla, P <0.01 and Houston/Phoenix, P = 0.03). The year of treatment trended toward significance (P = 0.077) on multivariate analysis using the ASTRO definition. CONCLUSIONS: For patients with intermediate-risk prostate cancer, brachytherapy-based treatment and the addition of AD to SD-EBRT resulted in improved biochemical outcomes compared with the outcomes with SD-EBRT alone; however, these findings were dependent on the definition of biochemical failure used. The year of treatment may be an important prognostic factor in intermediate-risk prostate cancer.

Management of ejaculatory duct obstruction: etiology, diagnosis, and treatment.

Abnormalities of the distal ejaculatory ducts related to infertility have been well-documented. Although there are no specific findings associated with ejaculatory duct obstruction, several clinical findings are highly suggestive. A diagnosis of ejaculatory duct obstruction is suggested in an infertile male with oligospermia or azoospermia with low ejaculate volume, normal secondary sex characteristics, testes, and hormonal profile, and dilated seminal vesicles, midline cyst, or calcifications on TRUS. Other causes of infertility may be concomitantly present and need to be evaluated and treated. Trans urethral resection of ejaculatory ducts (TURED) has resulted in marked improvement in semen parameters, and pregnancies have been achieved. Proper patient selection and surgical experience are necessary to obtain optimal results. In case of testicular dysfunction, chances of success are minimal. Extended follow-up periods are needed after TURED to examine the long-term effects of this procedure. Better understanding of the anatomy and pathology of the ejaculatory ducts will continue to refine diagnostic and therapeutic procedures for this disorder.

Reevaluation of TNM staging of renal cortical tumors: recurrence and survival for T1N0M0 and T3aN0M0 tumors are equivalent.

OBJECTIVES: The current TNM staging system for renal cortical tumors (RCTs) differentiates between tumors confined to the kidney (T1, T2) and tumors that extend through the renal capsule and invade into the perinephric fat (T3a). We examined the relative survival rates of patients with T1 and T3a tumors to determine the accuracy of the current TNM staging classification. METHODS: We analyzed the Columbia University Surgical Urological Oncology Database for all patients with clinically localized Stage T1, T2, and T3a RCTs treated surgically from 1988 to 2004. The primary outcomes included local and distant recurrence. Because the T3a classification is not limited by size, we compared T3a tumors with T1 tumors alone and tumors confined within the renal capsule (Stage T1 and T2 tumors combined). RESULTS: A total of 819 patients underwent partial or radical nephrectomy for RCTs at Columbia University during the study period. After the exclusion criteria were applied, 131 patients with T1N0M0, 19 patients with T2N0M0, and 82 patients with T3aN0M0 conventional renal cell carcinoma were eligible for analysis. The median follow-up was 37 months. The median tumor diameter was 3.2, 3.8, and 5.0 cm for Stage T1, T1 and T2 combined, and T3a lesions, respectively. The estimated 5-year disease-free survival was 95.2% and 90.6% for T1 and T3a RCTs, respectively (P = 0.922). CONCLUSIONS: Patients with Stage T3a tumors experienced similar outcomes as patients with tumors confined to the renal capsule. These data suggest that the T3a classification should be examined more closely to attempt to improve the prognostic validity of the TNM classification.

Transurethral resection of the ejaculatory ducts for treating ejaculatory symptoms.

OBJECTIVES: To report our experience with transurethral resection of the ejaculatory ducts (TURED) in infertile men with symptomatic ejaculatory duct obstruction (EDO). PATIENTS AND METHODS: Before surgery, all patients complained of a decrease in the volume of their ejaculate, 14 of 15 had a non-projectile ejaculation, nine had a genitourinary infection necessitating antibiotic treatment, and five had pain with orgasm. The mean ejaculate volume and total motile sperm count was 1.1 mL and 8.1 million sperm per ejaculate. After surgery, at a mean follow-up of 2 months, 10 men reported having projectile ejaculation, and eight reported a marked improvement in their sensation of orgasm. Overall, 14 men reported a subjective improvement in their ejaculation. The average postoperative ejaculate volume was 2.3 mL and the total motile sperm count was 38.1 million per ejaculate. CONCLUSIONS: Men with symptomatic EDO who underwent TURED showed improvements in their ejaculation, sensation of orgasm, semen analysis values and fertility.

Re-evaluation of the Tumour-Node-Metastasis staging of locally advanced renal cortical tumours: absolute size (T2) is more significant than renal capsular invasion (T3a).

UNLABELLED: Authors from Iowa City report on the incidence of RCC; they compared the rate of these tumours at autopsy and felt that the decrease found was a result of better antemortem detection, and an increase with time in the frequency of clinically detected renal cancer. A study from New York attempted to determine whether size, or transcapsular extension irrespective of size, was more likely to produce an adverse outcome. They analysed their database of 717 such tumours between 1988 and 2002, and found that absolute tumour size was the more significant of the two findings. OBJECTIVE: To determine which factor was more predictive of adverse outcome in our institutional experience with T2N0M0 and T3N0M0 renal cortical tumours (RCTs) treated surgically, as the current Tumour-Node-Metastasis (TNM) staging system for RCTs differentiates between tumours of >7.0 cm but confined to the renal capsule (T2) and tumours that extend through the renal capsule regardless of size (T3a). MATERIALS AND METHODS: We analysed our institutional database of surgical urological oncology for all patients with T2N0M0 and T3aN0M0 RCT treated with partial or radical nephrectomy from 1988 to 2002. All patients with preoperative metastasis, bilateral or multifocal tumours, nonsporadic disease or benign histology were excluded from analysis. A follow-up of > or = 6 months from the time of surgery was required for inclusion. Primary outcomes included local and distant recurrence, and death. RESULTS: In all, 717 patients had a partial or radical nephrectomy for RCT during the study period. After exclusion criteria were applied, 21 patients with T2N0M0 and 97 with T3aN0M0 tumours were eligible; the median (mean, range) age was 63 (16.6-88.3) years and follow-up 30.5 (40.8, 6-162) months. The estimated 5-year disease-free survival was 68% and 85% for T2N0M0 and T3aN0M0 RCT, respectively (P = 0.002). The 5-year disease-specific survival was 81% and 94% for the T2N0M0 and T3aN0M0 groups, respectively (P = 0.085). CONCLUSION: Patients with T3aN0M0 tumours appear to have better disease-free and disease-specific survival than those with T2N0M0 disease, which suggests that tumour invasion through the renal capsule is not as significant as the absolute tumour size.

Ejaculatory duct obstruction.

PURPOSE OF REVIEW: We surveyed the growing literature on ejaculatory duct obstruction and provide suggestions regarding its diagnosis and management. RECENT FINDINGS: Ejaculatory duct obstruction is a rare cause of male infertility. With the advent of the high resolution transurethral ultrasound (TRUS) technology, there has been an increase in diagnosis of this disorder. As for the treatment, it appears that central cystic lesions and partial obstructions respond best to transurethral resection of the ejaculatory ducts (TURED). SUMMARY: Ejaculatory duct obstruction is a rare but surgically correctable cause of male infertility. Although there are no pathognomonic findings associated with ejaculatory duct obstruction, the diagnosis should be suspected in an infertile male with oligospermia or azoospermia with low ejaculate volume, normal secondary sex characteristics, testes, and hormonal profile, and dilated seminal vesicles, midline cyst, or calcifications on TRUS. In select cases, TURED has resulted in marked improvement in semen parameters, and pregnancies have been achieved. More studies are needed in the areas of diagnosis and long-term surgical outcome.

Comparison of the predictive accuracy of serum prostate specific antigen levels and prostate specific antigen density in the detection of prostate cancer in Hispanic-American and white men.

PURPOSE: The Hispanic-American population is the fastest growing in the United States. Although many studies have looked at the performance of prostate specific antigen (PSA) in the detection of prostate cancer in white and black men, few have looked at it in relation to Hispanic men. The objective of this study was to compare the performance of PSA and PSA density (PSAD) in the detection of prostate cancer in Hispanic and white men. MATERIALS AND METHODS: A total of 404 consecutive Hispanic and 341 consecutive white men with elevated serum PSA and/or abnormal digital rectal examination underwent transrectal ultrasound with lesion directed and systematic peripheral zone biopsies from 1996 to 2001 at a single institution by 2 investigators (ETG, MCB). Before biopsy all patients underwent volume measurements of the entire prostate. Of these patients 242 Hispanic and 255 white men had a total PSA between 2.5 and 10 ng/ml. Serum PSA and calculated PSAD were compared between the positive and negative biopsy groups, and between Hispanic and white men. RESULTS: Of the 242 Hispanic and 255 white men 85 (35.1%) and 63 (24.7%) had cancer, respectively (p = 0.0147). There was no significant difference in age among the groups. There was no significant difference in median PSA between Hispanic and white men, or white men with malignant versus benign disease. There was a significant difference in median PSA in Hispanic men with malignant versus benign disease (6.3 vs 5.2 ng/ml, p = 0.0072). For PSAD there was a significant difference between Hispanic men with malignant versus benign disease (0.17 vs 0.12, p <0.0001) and white men with malignant versus benign disease (0.13 vs 0.11, p = 0.0019). Overall there was a difference in PSAD between positive and negative biopsy groups, and there was a significant difference in PSAD between Hispanic and white men (0.13 vs 0.11, p <0.0001). CONCLUSIONS: This study shows for the first time that at similar levels of total PSA, PSAD is higher in Hispanic than in white men. Furthermore, these data show that while PSA was able to discriminate between malignant versus benign disease in Hispanic men, it was not able to do so in white men. Given the large number of patients in this series perhaps different PSAD cutoffs need to be defined for Hispanic men. Further study in this area is warranted.

Is Hispanic race an independent risk factor for pathological stage in patients undergoing radical prostatectomy?

PURPOSE: Hispanic-Americans are the most rapidly growing population in the United States. Although many studies have assessed differences in pathological stage at radical prostatectomy between white and black American men, to our knowledge none has assessed it in Hispanic men. We compared pathological stage at radical prostatectomy in contemporaneous groups of Hispanic and white American men. MATERIALS AND METHODS: A total of 141 consecutive Hispanic and 314 consecutive white American men underwent radical retropubic prostatectomy for clinically localized prostate cancer from 1995 to 2002 at a single institution, as performed by one of us (ETG or MCB). Preoperative prostate specific antigen (PSA), age at diagnosis, race, clinical stage, biopsy and specimen Gleason score, pathological stage, specimen volume and calculated specimen PSA density were collected for each patient. Data were compared using standard statistical methods. RESULTS: Biopsy Gleason score, biopsy Gleason score distribution, specimen Gleason score, specimen Gleason distribution, pathological stage, calculated specimen PSA density, Gleason score change from biopsy to specimen and specimen prostate volume did not differ statistically between Hispanic and white men. Mean age and median preoperative PSA were statistically significantly higher in Hispanic vs white men (62.1 vs 59.5 years and 6.6 vs 5.4 ng/ml, respectively). In addition, no differences in the incidence of positive surgical margins, nonorgan confined disease, seminal vesicle invasion or positive lymph nodes were found between Hispanic and white men undergoing radical prostatectomy. CONCLUSIONS: This study shows that in contemporaneously treated groups of Hispanic and white men at the same institution pathological stage was similar between the groups. To our knowledge this is the largest comparison of surgically treated prostate cancer between these 2 groups. Further followup in terms of PSA outcome in these groups is planned.

Is Hispanic race an important predictor of treatment failure following radical prostatectomy for prostate cancer?

PURPOSE: Hispanic-Americans are the fastest growing minority group in the United States. Many studies have compared prostate cancer treatment outcomes between black and white men, but few such studies have been done with Hispanic men. We compared clinical and pathological features as well as the treatment failure rate of radical prostatectomy in contemporaneously treated groups of Hispanic and white men with prostate cancer. MATERIALS AND METHODS: Between 1995 and 2002, 136 Hispanic men and 315 white men underwent radical prostatectomy. Treatment failure was defined as having a prostate specific antigen (PSA) of 0.2 or greater more than 8 weeks after surgery or receiving any adjuvant therapy. Known predictors of failure and race were evaluated for their ability to predict treatment failure. RESULTS: Median followup was 32 months for Hispanic and 36 months for white patients. Hispanic men were older, had a higher percentage of abnormal rectal examinations, Gleason 7 tumors and preoperative PSA levels greater than 10. Preoperative PSA, specimen Gleason score, pathological stage and surgical margin were all strongly associated with treatment failure (p<0.001). Despite differences in clinical characteristics, overall failure rates did not differ between Hispanic and white men (18.7% vs 17.8%). The odds ratio for treatment failure for Hispanic relative to white men after adjusting for the previously mentioned risk factors was 0.87 (95% CI [0.44, 1.68], p = 0.670). CONCLUSIONS: This study shows that Hispanic race does not influence the treatment failure rate of radical prostatectomy in contemporaneously treated patients with prostate cancer at 1 institution. To our knowledge this study represents the largest of its kind, but longer followup and other confirmatory studies are needed.

Natural history and clinical outcome of sporadic renal cortical tumors diagnosed in the young adult.

OBJECTIVES: To determine the natural history of patients younger than 40 years (young patient [YP] group) who are diagnosed with a sporadic renal cortical tumor (RCT) and to compare the natural history of these patients with the more typical older patient (OP) with RCT. METHODS: We reviewed our database and identified 34 patients (younger than 40 years old, median age 35) who underwent surgery for a sporadic RCT. The YP group outcomes were compared with 100 patients between 41 and 85 years (median 65). We fit a Cox proportional hazards model to examine the relationship between age at presentation and recurrence risk. RESULTS: The median tumor size in the YP group was 3.8 cm (range 0.6 to 19) and in the OP group was 5.0 cm (range 0.9 to 22; P = 0.225). Tumors were discovered incidentally in 51% and 56% of the YP and OP groups, respectively (P = 0.65). The frequency of partial nephrectomy did not differ between the two groups (35% YP and 30% OP, P = 0.55). The frequency of malignant histologic subtypes did not differ between the groups (P = 0.439). In the YP group, only larger tumor size (hazard ratio 1.23, 95% confidence interval 1.02 to 1.50, P = 0.034) was associated with a statistically significant increased risk of recurrence. Those in the YP group were not more or less likely to develop recurrence than those in the OP group (hazard ratio 0.79, 95% confidence interval 0.22 to 2.85, P = 0.72). The 5-year disease-free survival rate was 73% and 80% in the YP and OP groups, respectively (P = 0.23). The 5-year disease-specific survival rate was 85% and 84% in the YP and OP groups, respectively (P = 0.88). CONCLUSIONS: The findings of our study indicate that the natural history of RCTs is similar in both younger and older patients. Young patients were neither more nor less likely to develop recurrence compared with their older counterparts.

Seminal vesicle involvement after radical prostatectomy: predicting risk factors for progression.

OBJECTIVES: To evaluate and study the factors for progression after radical prostatectomy with seminal vesicle invasion in a cohort of European and American patients. METHODS: The data of 137 patients with isolated seminal vesicle invasion who underwent radical retropubic prostatectomy between 1988 and 2001 were analyzed. The Gleason score of the specimen, presence of capsular invasion, and surgical margin status were noted. Follow-up data were obtained through routine serum prostate-specific antigen (PSA) assays and digital rectal examinations. A defining criterion for progression was a postoperative serum PSA level greater than 0.2 ng/mL or any postoperative radiotherapy or hormonal treatment. Kaplan-Meier analysis was used to determine the actuarial biochemical recurrence-free likelihood, and the log-rank test was used to compare these results. Differences were considered statistically significant when the P value was less than 0.05. RESULTS: After a mean follow-up of 4.9 years (range 0.9 to 13.4), 70 patients (51.9%) had progression. The biochemical 5-year progression-free survival rate was 33.8%. In univariate and multivariate analyses, only preoperative PSA level (P = 0.001) and Gleason score of the specimen (P = 0.01) were independent predictors of progression. Neither capsular invasion nor positive surgical margins predicted progression. When an analysis was performed according to the major Gleason grade of the radical prostatectomy specimen, Gleason grade 5 was associated with a worse prognosis compared with Gleason grade 3 and 4 (P = 0.01). The mean time to progression was 20.5, 17.1, and 10.1 months for Gleason grade 3, 4, and 5, respectively. CONCLUSIONS: Seminal vesicle invasion after radical prostatectomy has historically been associated with a poor prognosis. However, in the present study, seminal vesicle invasion was associated with a 34% rate of freedom from progression at 5 years after surgery alone. Preoperative PSA and Gleason score of the radical prostatectomy specimen were independent factors for progression in the present study, which described the largest patient group to date. The Gleason grade of the radical prostatectomy specimen distinguished among different times to progression.