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Biomedical subjects

A R Zlotta

Publications and source records attributed to A R Zlotta.

At least 19 recordsLinked to original sources
PubMed1999

Total and transition zone prostate volume and age: how do they affect the utility of PSA-based diagnostic parameters for early prostate cancer detection?

OBJECTIVES: To define the role of total prostate (TP) volume, transition zone (TZ) volume, and age as determinants of the utility of prostate-specific antigen (PSA)-based diagnostic parameters for early detection of prostate cancer (PCa) in a prospective multicenter study. METHODS: The study participants were 974 consecutive men with serum total PSA (tPSA) levels of 4 to 10 ng/mL who were referred for early PCa detection or lower urinary tract symptoms. All patients underwent prostate ultrasound examination and sextant biopsy with two additional TZ biopsies. In patients with negative initial biopsies, repeated biopsies were performed at 6 weeks. tPSA, the free/total PSA ratio (f/t PSA), PSA density of the TZ (PSA-TZ), PSA density (PSAD), and PSA velocity (PSAV) were determined and compared across TP volume strata of 30 cm3 or less and greater than 30 cm3, TZ volume strata of 20 cm3 or less and greater than 20 cm3, and various age groups to evaluate the need for volume and/or age-specific reference ranges. RESULTS: PCa was found in 345 (35.4%) of 974 patients and benign prostatic tissue was found in 629 (64.6%) of 947 patients. Across TP volume strata, significantly higher values of tPSA (P <0.01), PSA-TZ, PSAD (P <0.001), and PSAV (P <0.05) and lower values of f/t PSA (P <0.001) were observed in patients with PCa than in those without PCa. Similar results were obtained with respect to TZ volume strata, except in the case of PSAV (P <0.05). tPSA, PSA-TZ, and PSAD were significantly higher (P <0.05) in patients with PCa than in those without PCa for all corresponding age ranges. In patients with PCa, f/t PSA was significantly lower (P <0.001) within the same age ranges. Within each group (PCa or benign), f/t PSA, PSAD, PSA-TZ, and PSAV values were unaffected by age strata. However, PSA parameters dependent on prostate volume (PSAD, PSA-TZ) were statistically lower (P <0.001) in prostates with a higher TP volume (greater than 30 cm3) and TZ volume (greater than 20 cm3); f/t PSA values were unaffected by TP and TZ volumes. CONCLUSIONS: f/t PSA and PSA-TZ were the most powerful parameters to differentiate between benign prostatic tissue and PCa. f/t PSA was the sole parameter unaffected by age and prostate volume. We believe new volume-specific cutpoints, as presented in the current study, should be employed when using PSAD and PSA-TZ for the early detection of PCa.

Adult↗
PubMed1999

The importance of measuring the prostatic transition zone: an anatomical and radiological study.

OBJECTIVE: To assess the accuracy and reliability of measurements of the volume of the transition zone (TZ, representing the hypertrophied benign component) and whole prostate by TRUS in patients with BPH or cancer, by comparing the radiological with pathological findings after surgery. PATIENTS AND METHODS: The study comprised 36 patients with prostate cancer undergoing radical prostatectomy and 34 patients with symptomatic BPH treated using retropubic adenectomy. The weights of the radical prostatectomy specimens and of the enucleated adenomas were correlated with the corresponding volumes of the TZ and of the whole prostate, respectively, measured by TRUS using the prolate ellipsoid method. RESULTS: The mean (sd) TZ volume measured by TRUS was 36.9 (25.48) mL, whereas the weight of the enucleated specimen was 42.7 (33.58) g (correlation coefficient r=0.95, P<0.001). The TRUS estimate of the volume of the whole prostate was 29.2 (9.24) mL, while the radical prostatectomy specimens weighed 34.5 (10.76) g (r=0.78, P<0.001). The variability in the TZ volume estimate ranged from -17% to +18%, whereas the variability for whole prostate was -21% to +30% (P<0.05). CONCLUSIONS: Measurements of the TZ of the prostate by TRUS are more accurate than those for the whole prostate. An assessment of the TZ volume may be sufficiently reliable to be used in the clinical management of BPH and to detect prostate cancer using the prostate-specific antigen density of the TZ as a marker.

Humans↗
PubMed1999

Clinical evolution of prostatic intraepithelial neoplasia.

High-grade prostatic intraepithelial neoplasia (PIN) is most likely a precursor of prostate cancer and is frequently associated with it whereas the direct link between low-grade PIN and cancer is not established. The clinical evolution of isolated high-grade PIN has been the object of much concern because of the possibility of undiagnosed prostate cancer or the evolution of this premalignant lesion in invasive carcinoma. Parameters predictive of the later finding of prostate cancer on repeat biopsy in patients with PIN are of evident interest and we have reviewed our experience and recent data from the literature on this topic as well as on the clinical management of these patients. Low-grade PIN is not by itself a risk of later cancer found on repeat biopsy unless other factors such as PSA increase the cancer suspicion. Patients with low-grade PIN and high serum PSA should therefore undergo repeat biopsies. Patients with low-grade PIN and without additional factors should be followed. Patients with high-grade PIN should systematically be rebiopsied. If a second set is still consistent with PIN, they should undergo additional biopsies again within 3-6 months because they are likely to have an undiagnosed cancer.

Adenocarcinoma↗
PubMed1999

BPH and sexuality.

Quality of life has become a very important parameter in benign prostatic hyperplasia (BPH) and one of the major concepts identified by the patients to be important is related to sexuality after BPH therapy. The impact on sexuality resulting from the various treatment modalities of BPH, either medical, surgical or instrumental has been too often neglected in the past and poorly investigated. The present article reviews the influence on sexual function of current therapies for symptomatic BPH.

Adrenergic alpha-Antagonists↗
PubMed1999

Correlation and prognostic significance of p53, p21WAF1/CIP1 and Ki-67 expression in patients with superficial bladder tumors treated with bacillus Calmette-Guerin intravesical therapy.

PURPOSE: We determine if, before intravesical bacillus-Calmette Guerin (BCG) therapy, p53, p21WAF-1-CIP1 (a critical downstream effector of p53 pathway of cell growth control, inhibiting cyclin dependent kinases) and the cell proliferation marker Ki-67 (MIB-1) could be used as prognostic markers of response to BCG in patients with superficial bladder tumors. MATERIALS AND METHODS: The study included 47 patients with superficial bladder tumors at high risk for recurrence or progression treated with 6 weekly intravesical BCG instillations. We analyzed p53, p21 and Ki-67 on paraffin embedded samples by immunohistochemistry and the percentage of positive cells was determined in a blinded fashion. Quantitative immunostaining was analyzed in relation to time to recurrence and progression using univariate or multivariate analysis and the Kaplan-Meier method. RESULTS: During a mean followup of 24.6 months 23 of the 47 patients (48.9%) presented with tumor recurrence and 10 (21.2%) had later progression to invasive disease. A p21 over expression (greater than 10%) was observed in 23 tumors (48.9%) and positively correlated with p53 (p = 0.0097) but not with Ki-67 (p = 0.327). Of the tumors 18 (38.2%) were p53 and p21 negative. Among p21 positive tumors 15 (65.2%) were p53 and p21 positive, suggesting that p21 may also be regulated by p53 independent pathways. However, p53 did not act as a predictor of recurrence or progression. In contrast, using Kaplan-Meier curves p21 over expression (greater than 10%) and Ki-67 at a 25% cutoff were associated with shorter recurrence-free survival (both p = 0.02 log rank test) but they did not predict additional information about risk of progression. However, multivariate analysis failed to demonstrate any independent prognostic value for p21 or Ki-67 in contrast to tumor stage. CONCLUSIONS: Our results indicate that p21WAF-1-CIP1 seems to be regulated by p53 independent pathways in superficial bladder cancer. The present study did not indicate an independent prognostic significance in patients treated with BCG for p53, p21WAF-1-CIP1 or Ki-67 markers. Larger prospective studies are needed to evaluate further the independent value of these biological markers in superficial bladder cancer management.

Adjuvants, Immunologic↗
PubMed1999

Combination and multivariate analysis of PSA-based parameters for prostate cancer prediction.

The aim of this study was to evaluate the ability of prostate-specific antigen (PSA)-based parameters including PSA density (PSAD), PSAD of the transition zone (PSA-TZ), percent free PSA, PSA velocity, and their combination to enhance the specificity of PSA for prostate cancer detection in men with serum PSA levels between 4 and 10 ng/mL. We evaluated prospectively 559 consecutive men referred for early detection of prostate cancer who had serum PSA levels between 4 and 10 ng/mL. All men underwent prostatic ultrasonography and sextant biopsy with two additional TZ biopsies. In all cases, if first biopsies were negative an additional set of biopsies was obtained within 6 weeks. The ability of PSAD, PSA-TZ, PSA velocity, percent free PSA, and their combination to improve the detection of prostate cancer was evaluated by univariate and multivariate analysis as well as receiver operating characteristic (ROC) curves. In this prospective study of 559 patients, 217 had prostate cancer and 342 had histologically confirmed benign prostatic hyperplasia. Multivariate analysis and ROC curves showed that PSA-TZ and percent free PSA (f/t PSA) were the most powerful and highly significant predictors of prostate cancer. Areas under the ROC curve (AUC) for PSA-TZ and percent free PSA were 0.827 and 0.778, respectively (p = .01). Combination of f/t PSA with PSA-TZ (AUC = 88.1%) significantly increased AUC as compared to each of the other parameters alone as well as their combination (p = .02). The next best combinations were PSA-TZ + PSAD, PSA-TZ + PSA, and f/t PSA + PSA. PSA-TZ followed by f/t PSA and PSAD were the most powerful predictors of prostate cancer in referred patients with a serum PSA between 4 and 10 ng/mL. f/t PSA + PSA-TZ was the most effective combination. When volume-independent PSA parameters were taken into consideration, f/t PSA + PSA clearly outperformed the other options.

Aged↗
PubMed1998

Superficial bladder tumors and increased reactivity against mycobacterial antigens before bacillus Calmette-Guerin therapy.

PURPOSE: The precise mechanism of action of bacillus Calmette-Guerin (BCG) in bladder cancer treatment remains poorly understood. Whether bladder tumor cells are destroyed by nonspecific mechanisms or targeted by specifically activated lymphocytes recognizing cognate antigens is unclear. To investigate a possible cross-reactivity between BCG and bladder cell tumors, we tested before BCG treatment the lymphoproliferation of peripheral blood lymphocytes against several mycobacterial antigens, including the secreted fibronectin binding antigen 85 complex from BCG (AG 85) in patients with superficial bladder tumors compared to control matched patients. MATERIALS AND METHODS: Using a whole blood assay, T cell response against purified protein derivative, BCG extract, whole BCG, purified AG 85, and the nonspecific mitogens pokeweed and phytohemagglutinin was investigated in 79 patients with superficial bladder tumors before BCG and in 39 control subjects without malignancy matched for age and sex. Neither group had a history of tuberculosis. Lymphoproliferation was measured with a tritiated thymidine uptake assay on day 7 of culture. RESULTS: Of the 79 patients with superficial transitional cell carcinoma, a significant lymphoproliferative response before BCG against PPD, BCG extract, whole BCG and AG 85 was observed in 65 (82.2%), 67 (84.81%), 30 (37.97%) and 49 (62.02%) patients, respectively. Of the 39 controls only 26 (64.1%), 23 (58.9%), 3 (7.7%) and 3 (7.7%) patients, respectively, had a significant lymphoproliferation against PPD, BCG extract, BCG and AG 85 (p >0.05, p = 0.004, p = 0.00001 and p = 0.00001, respectively). In terms of lymphoproliferative levels, patients with superficial transitional cell carcinoma also showed a significantly higher response against PPD (p = 0.000012), BCG extract (p = 0.000001), AG 85 (p = 0.000001), whole BCG (p = 0.00001) and pokeweed (p = 0.01) than controls but not against phytohemagglutinin. CONCLUSIONS: Patients with superficial transitional cell carcinoma demonstrate an increased lymphoproliferation against mycobacterial antigens before BCG compared to control subjects. Although a nonspecific activation of the immune system cannot be excluded at this stage, our data may suggest the possible existence of bladder cancer antigens cross-reactive with mycobacterial antigens responsible for boosting precursor cells witnessing previous contacts with mycobacteria. The implication of these findings in the antitumoral mechanism of action of BCG are under investigation.

Adhesins, Bacterial↗
PubMed1998

Percutaneous transperineal radiofrequency ablation of prostate tumour: safety, feasibility and pathological effects on human prostate cancer.

OBJECTIVE: To evaluate the safety of radiofrequency (RF) energy delivered interstitially in patients with prostate cancer scheduled for radical prostatectomy and to correlate the proposed theoretical lesion size with the pathological findings. PATIENTS AND METHODS: Radiofrequency interstitial tumour ablation (RITA) was performed in 15 patients with localized prostate cancer before radical surgery. RF energy was delivered to the prostate by active needle electrodes (monopolar or bipolar) placed transperineally under transrectal ultrasonography guidance. Needle electrodes were used with different configurations and in some cases were covered by retractable shields to vary the length and circumference of the thermal lesions created. In eight patients, the procedure was performed immediately before radical prostatectomy, in six RITA was performed under spinal anaesthesia 1 week before surgery and in one patient, no surgery was performed but the patient was followed by serial determinations of prostate specific antigen (PSA). At least two lesions were created in each prostate, including both capsule and peripheral zones. NADPH and haematoxylin & eosin (H&E) staining were used to assess the extent of the necrotic lesion in the radical prostatectomy specimen. RESULTS: The mean energy delivered was 10.5 kJ, with central temperatures reaching up to 105 degrees C during 12 min of ablation; rectal temperature remained at < 38 degrees C. There were no complications. Macroscopic examination showed well-demarcated lesions including the prostatic capsule, up to 2.2 x 1.5 x 4.5 cm. With monopolar energy, the observed lesion size was comparable to the predicted 2 x 2 x 2 cm lesion, while with bipolar energy, lesion size was related to interneedle distance and uncovered needle length. Microscopic examination showed clearly delineated lesions both with NADPH (in prostates immediately removed after surgery) and H&E (at 1 week after RITA) staining. The lesion size observed on pathological analysis correlated with the predicted lesion size. In one patient, no residual cancer was found in the specimen. In the patient whose entire prostate was targeted and followed by serial PSA measurements, the latter were undetectable at 3 months of follow-up. CONCLUSION: Transperineally delivered RF energy is capable of safely creating extensive coagulative necrotic lesions in prostate cancer tissue, in a reproducible and controlled manner. The results presented here provide basic information for the potential future application of this form of energy for localized prostate cancer.

Catheter Ablation↗
PubMed1998

Prostate specific antigen density of the transition zone for predicting pathological stage of localized prostate cancer in patients with serum prostate specific antigen less than 10 ng./ml.

PURPOSE: Prostate specific antigen (PSA) density of the transition zone, which is the density of serum PSA related to the volume of the transition zone, has been recently demonstrated to enhance prostate cancer prediction in patients with intermediate PSA levels. We further investigated the usefulness of PSA-transition zone for predicting extraprostatic extension in clinically localized prostate cancer. MATERIALS AND METHODS: Measuring the transition zone of the prostate by ultrasound using the prolate ellipsoid method, PSA-transition zone values were calculated prospectively in 198 patients with clinically localized prostate cancers and serum PSA less than 10.0 ng./ml. who underwent radical retropubic prostatectomy. The ability of PSA-transition zone to predict extracapsular disease in the surgical specimen was compared to Gleason score, serum PSA, PSA density of the total prostate and percent free PSA using univariate or multivariate analysis as well as receiver operating characteristics curves. RESULTS: A total of 104 patients (52.5%) had pathologically organ confined prostate cancer while 94 of 198 (47.5) had extracapsular disease. PSA-transition zone levels were significantly higher in extracapsular disease than organ confined cancers (0.84 versus 0.42 ng./ml./cc, p <0.00001). Using multivariate analyses PSA-transition zone and Gleason score were the most significant predictors of extracapsular disease. The area under the curve was larger for PSA-transition zone (0.825) than any other parameter (p <0.004 versus PSA density and p <0.001 versus PSA, percent free PSA or Gleason score). A cutoff of 1.00 ng./ml./cc for PSA-transition zone provided 95.1% specificity and 28.8% sensitivity for predicting extracapsular disease. Probability plots using the best combination of independent variables for predicting extraprostatic extension were developed. CONCLUSIONS: These data demonstrate that the use of the PSA-transition zone may be of additional value for indicating which patients with clinically localized prostate cancer and PSA less than 10.0 ng./ml. are at high risk for extracapsular disease.

Aged↗
PubMed1998

Transperineal radiofrequency interstitial tumor ablation (RITA) of the prostate.

The purpose of this study was to investigate the safety and feasibility of radiofrequency interstitial tumor ablation (RITA) in localized prostate cancer (PCa) and to assess the predictability of the lesions obtained. In 10 patients with localized PCa (mean age 70.4 years), a total of 21 marker lesions were induced under general (n = 3), spinal (n = 4), or local anesthesia only (n = 3). Radiofrequency energy was delivered transperineally under transrectal ultrasound (TRUS) guidance. Radical prostatectomy was performed in all patients 1-7 days after RITA. The findings of intraoperative TRUS and histologic examination of the specimen were correlated. Lesions 2 x 2 x 2 cm were targeted. Postoperatively, patients were catheterized for an average of 1.8 days (range 1-3). Average lesion diameters defined by coagulative necrosis at histologic examination were 2.20 +/- 0.23 x 2.10 +/- 0.31 x 2.38 +/- 0.14 cm (average volume 5.86 +/- 1.63 cm3). Lesions were well defined and did not extend beyond the prostatic capsule. No complications (e.g., rectal wall injury) were noted. RITA-induced lesions were safe, feasible, technically simple, and resulted in lesions well predictable in size and location. On histologic examination, well-defined areas of coagulative necrosis were documented. No damage to the periprostatic tissue was noted. The procedure can be performed with spinal or local anesthesia only.

Aged↗
PubMed1998

Prostate specific antigen density of the transition zone for early detection of prostate cancer.

PURPOSE: We compare the ability of several prostate specific antigen (PSA) parameters, including PSA density of the whole prostate and of the transition zone, percent free PSA and PSA velocity, to enhance the specificity for prostate cancer detection and to reduce unnecessary biopsies in men with serum PSA levels of 4 to 10.0 ng./ml. MATERIALS AND METHODS: This prospective study included 559 consecutive men referred for early prostate detection or lower urinary tract symptoms who had a serum PSA of 4.0 to 10.0 ng./ml. All men underwent prostatic ultrasonography and sextant biopsy with 2 additional transition zone biopsies. Specific biopsies of abnormal findings on digital rectal examination were also performed. In all cases if first biopsies were negative an additional set of biopsies was performed within 6 weeks. The ability of PSA density, PSA transition zone, PSA velocity and percent free PSA to improve the power of PSA in the detection of prostate cancer was evaluated with univariate and multivariate analyses as well as receiver operating characteristics (ROC) curves. RESULTS: Of 559 patients 342 had histologically confirmed benign prostatic hyperplasia and 217 had prostate cancer. Mean serum PSA, PSA velocity, PSA density and PSA transition zone were statistically higher (p <0.018, p <0.037, p <0.0001 and p <0.0001, respectively) and percent free PSA was statistically lower (p <0.0001) in patients with prostate cancer than in those with benign disease. Multivariate analysis and ROC curves showed that PSA transition zone and percent free PSA were the most powerful and highly significant predictors of prostate cancer. Areas under the ROC curve for PSA transition zone and percent free PSA were 0.827 and 0.778, respectively (p=0.01 McNemar test). Combination of free-to-total PSA with PSA transition zone significantly increased the area under the ROC curve compared to PSA transition zone alone (p=0.020). With a 95% sensitivity for prostate cancer detection a PSA transition zone cutoff of 0.25 ng./ml./cc would result in the lowest number of unnecessary biopsies (47% PSA transition zone specificity) compared to all other PSA parameters. However, total prostate volume (greater than 30 cc in 422 men or less than 30 cc in 137) was an important factor in predicting the statistical performance of PSA transition zone. In fact, PSA transition zone did not outperform free percent PSA in sensitivity and specificity when the entire prostate gland volume was less than 30 cc (p=0.094 McNemar test). CONCLUSIONS: PSA density of the transition zone enhances the specificity of serum PSA for prostate cancer detection in referred patients with a serum PSA of 4.0 to 10.0 ng./ml. compared to other PSA parameters currently available. While PSA transition zone was more effective in prostates greater than 30 cc and percent free PSA was more effective in prostates less than 30 cc, the combination of percent free PSA with PSA transition zone further increased prostate cancer prediction.

Aged↗
PubMed1998

[Use of transrectal ultrasonography in prostate pathology: determination and clinical usefulness of the prostate transition zone].

The prostate gland comprises a central or transition zone which is the object of an important hypertrophy in case of benign prostatic hypertrophy and a peripheral zone where the vast majority of cancers occurs. The ultrasonographic measurement of the prostate transition zone volume has become a very important parameter to consider in the assessment of the severity of symptoms or the therapeutic options in case of benign prostatic hyperplasia. When a prostate cancer is suspected, a new concept, the prostate specific antigen density related to the transition zone volume, has been demonstrated as a very effective mean for prostate cancer early detection in men with PSA levels below 10 ng/ml.

5-alpha Reductase Inhibitors↗
PubMed1997

Transperineal radiofrequency interstitial tumor ablation of the prostate: correlation of magnetic resonance imaging with histopathologic examination.

OBJECTIVES: Radiofrequency (RF) energy has recently been employed to destroy human tissue in vivo. The purpose of this study was to investigate the safety of this approach in localized carcinoma of the prostate (CaP) and specifically, the predictability of lesions obtained with radiofrequency interstitial tumor ablation (RITA). METHODS: Using RITA, a total of 21 lesions were induced in 10 patients with localized CaP (mean age 70.4 years). RF was delivered transperineally under transrectal ultrasound (TRUS) guidance. All patients underwent endorectal magnetic resonance imaging (MRI) before and after treatment. Radical prostatectomy was performed in all patients 1 to 7 days after RITA. Three of the patients were treated with local anesthesia only. The predictability of the thermal lesion was assessed by correlating the findings of intraoperative TRUS, pre- and post-RITA endorectal MRI, and the histologic examination of the specimen. RESULTS: Postoperatively, patients were catheterized for an average of 1.8 days (1 to 3 days). Lesions of 2 x 2 x 2 cm were targeted. Average lesion diameters obtained on MRI were 2.08 +/- 0.23 x 2.09 +/- 0.36 x 2.28 +/- 0.21 cm. Average lesion diameters defined by coagulative necrosis at histologic examination were 2.20 +/- 0.23 x 2.10 +/- 0.31 x 2.38 +/- 0.14 cm. There were no statistically significant differences (P = 0.377) between average lesion volume on MRI (5.37 +/- 1.83 cm3) and average lesion volume at histology (5.86 +/- 1.63 cm3). No complications or adverse events were noted. CONCLUSIONS: In this Phase I study, RITA was shown to be safe and feasible, and to result in lesions that were predictable in size and location. MRI accurately visualized and verified the area of coagulative necrosis as documented at histology. The procedure is technically simple and can even be performed under local anesthesia.

Aged↗
PubMed1997

Humoral response against heat shock proteins and other mycobacterial antigens after intravesical treatment with bacille Calmette-Guérin (BCG) in patients with superficial bladder cancer.

Few studies have analysed the antibody response during intravesical BCG immunotherapy for superficial bladder cancer. We have examined the evolution in serum antibody response against several heat shock proteins (hsp), including the recombinant mycobacterial hsp65 and the native protein P64 from BCG, GroEL from Escherichia coli (hsp60 family), recombinant mycobacterial hsp70 and the E. coli DnaK (hsp70 family), against purified protein derivative of tuberculin (PPD) and the AG85 complex of Mycobacterium bovis BCG, as well as against tetanus toxoid in 42 patients with a superficial bladder tumour, 28 treated with six intravesical BCG instillations and 14 patients used as controls. We also analysed the lymphoproliferative response of peripheral blood mononuclear cells against PPD in this population. Data of antibody responses at 6 weeks post BCG were available in all 28 patients, and at 4 month follow up in 17 patients. All patients who demonstrated a significant increase in IgG antibodies against PPD at 4 months follow up had a significant increase already at 6 weeks of follow up. In contrast, IgG antibodies against hsp increased significantly from 6 weeks to 4 months post-treatment. A significant increase in IgG antibodies against PPD, hsp65, P64, GroEL, and hsp70 at 4 months follow up was observed in 10/17, 8/17, 10/17, 4/17 and 8/17 patients. Native P64 protein elicited a higher antibody response than recombinant mycobacterial hsp65. No increase in antibody response was observed against Dnak from E. coli, against AG85 or tetanus toxoid after BCG therapy. An increase in IgG antibodies against P64 at 4 months follow up compared with pretreatment values was found to be a significant predictor of tumour recurrence (P<0.01). Further studies with a larger number of patients are needed to confirm the value of the antibody response against P64 as a clinical independent prognostic factor.

Administration, Intravesical↗