We performed a head-to-head comparison of the PHI (Prostate Health Index) and PCA3. Materials and... more We performed a head-to-head comparison of the PHI (Prostate Health Index) and PCA3. Materials and Methods: We evaluated PHI and PCA3 performance in 211 patients undergoing initial (116) or repeat (95) prostate biopsy. Multivariable logistic regression analysis was done using the AUC to test the accuracy of PHI and PCA3 for predicting prostate cancer in the overall population and in each setting. Decision curve analysis was used to compare the clinical benefit of different models. Results: Overall, the AUC of the PHI (0.70) was significantly higher than the AUC of PCA3 (0.59), total prostate specific antigen (0.56) and free-to-total prostate specific antigen (0.60) (p ϭ 0.043, 0.002 and 0.037, respectively). PHI was more accurate than PCA3 for predicting prostate cancer in the initial setting (AUC 0.69 vs 0.57) and in the repeat setting (AUC 0.72 vs 0.63), although no statistically significant difference was observed. Including PCA3 in the base multivariable model (prostate specific antigen plus free-to-total prostate specific antigen plus prostate volume) did not increase predictive accuracy in either setting (AUC 0.79 vs 0.80 and 0.75 vs 0.76, respectively). Conversely, including PHI in the base multivariable model improved predictive accuracy by 5% (AUC 0.79 to 0.84) and 6% (AUC 0.75 to 0.81) in the initial and repeat prostate biopsy settings, respectively. On decision curve analysis the highest net benefit was observed when PHI was added to the base multivariable model. Conclusions: PHI and PCA3 provide a significant increase in sensitivity and specificity compared to all other examined markers and they may help guide biopsy decisions. PCA3 does not increase the accuracy of predicting prostate cancer when PHI is assessed.
A study on the effects of hyperthermia on B.N.A. induced bladder carcinomas of the dog has been c... more A study on the effects of hyperthermia on B.N.A. induced bladder carcinomas of the dog has been carried out since 1966. The hyperthermic treatment has been performed directly in the bladder using an original equipment especially designed. In a large majority of the animals definite cancericidal changes have been shown. The most favorable results were obtained in the treatment of carcinomas not infiltrating the muscular layer of the bladder. In these cases malignant recurrency was not shown up to five years after treatment. Good palliative effect is also refferred in the treatment of advanced bladder carcinoma of the man.
An experimental study by the authors, on the effects of local-regional hyperthermia on bladder B.... more An experimental study by the authors, on the effects of local-regional hyperthermia on bladder B.N.A. induced carcinoma of the dog has been going on since 1966. The authors have observed complete disappearance in the animals of the mucosa and sub-mucosa neoplasia, even after 6 years from the date of treatment. The sterilization of the neoplastic surface was checked by several histological sections observations on two excised bladders. As the results showed no negative secondary effects, the authors have started, since 1973, a clinical study of hyperthermia treatment of the bladder, vagina, female urethra and rectum stump carcinoma. Heat was obtained and introduced into the bladder by leans of an apparatus specifically designed for this purpose; the double-circuit terminal probe supplies a thermocouple controlled constant temperature. We are submitting the cases treated together with a discussion on results obtained and problems faced.
Objective: To evaluate the patterns of prescription of androgen deprivation therapy (ADT) in pati... more Objective: To evaluate the patterns of prescription of androgen deprivation therapy (ADT) in patients with prostate cancer (PCa) and the adherence to European Association Urology (EAU) guidelines for ADT prescription.
Urologic Oncology: Seminars and Original Investigations, 2015
Objective: To determine if prostate health index (PHI), prostate cancer antigen gene 3 (PCA3) sco... more Objective: To determine if prostate health index (PHI), prostate cancer antigen gene 3 (PCA3) score, and percentage of free prostatespecific antigen (%fPSA) may be used to differentiate asymptomatic acute and chronic prostatitis from prostate cancer (PCa), benign prostatic hyperplasia (BPH), and high-grade prostate intraepithelial neoplasia (HG-PIN) in patients with elevated PSA levels and negative findings on digital rectal examination at repeat biopsy (re-Bx). Patients and methods: In this prospective study, 252 patients were enrolled, undergoing PHI, PCA3 score, and %fPSA assessments before re-Bx. We used 3 multivariate logistic regression models to test the PHI, PCA3 score, and %fPSA as risk factors for prostatitis vs. PCa, vs. BPH, and vs. HG-PIN. All the analyses were performed for the whole patient cohort and for the "gray zone" of PSA (4-10 ng/ml) cohort (171 individuals). Results: Of the 252 patients, 43 (17.1%) had diagnosis of PCa. The median PHI was significantly different between men with a negative biopsy and those with a positive biopsy (34.9 vs. 48.1, P o 0.001), as for the PCA3 score (24 vs. 54, P o 0.001) and %fPSA (11.8% vs. 15.8%, P ¼ 0.012). The net benefit of using PCA3 and PHI to differentiate prostatitis and PCa was moderate, although it extended to a good range of threshold probabilities (40%-100%), whereas that from using %fPSA was negligible: this pattern was reported for the whole population as for the "gray zone" PSA cohort. Conclusion: In front of a good diagnostic performance of all the 3 biomarkers in distinguishing negative biopsy vs. positive biopsy, the clinical benefit of using the PCA3 score and PHI to estimate prostatitis vs. PCa was comparable. PHI was the only determinant for prostatitis vs. BPH, whereas no biomarkers could differentiate prostate inflammation from HG-PIN.
To evaluate pathological patterns of prostate biopsy in men with changes in risk class by prostat... more To evaluate pathological patterns of prostate biopsy in men with changes in risk class by prostate cancer gene 3 (PCA3) score and with elevated serum prostate-specific antigen (PSA) or positive digital rectal examination (DRE), undergoing a repeat biopsy. A total of 108 males of two Italian Institutions who had undergone at least two PCA3 score assessments with changed PCA3 risk class were selected. Comparison of PCA3 score in patients with negative re-biopsy [normal parenchyma, benign prostatic hyperplasia (BPH), chronic prostatitis, high-grade prostate intraepithelial neoplasia (HG-PIN), atypical small acinar prostate (ASAP)] or positive re-biopsy was performed. The up- and down-grading rates for PCA3 score were 71.3% (n=77) and 28.7% (n=31), respectively. Among the 77 up-graded patients, the median change in PCA3 score was 24 (range=4-69), while among the 31 down-graded ones, the median change was 17 (2 to 55). The PCA3 score in 24 out of 29 (82.7%) patients with prostate cancer ...
Analytical and quantitative cytology and histology / the International Academy of Cytology [and] American Society of Cytology, 2012
To determine an optimal prostate cancer gene 3 (PCA3) cutoff in predicting prostate cancer in Ita... more To determine an optimal prostate cancer gene 3 (PCA3) cutoff in predicting prostate cancer in Italian patients undergoing first or repeat biopsy. In this observational multicenter study 1246 men with elevated prostate specific antigen (PSA) and negative digital rectal examination, with prostate biopsy after PCA3 assessment, were divided into two groups submitted to PCA3 testing before or after previous negative biopsies. Ideal PCA3 cutoff was identified using area under the curve of the receiver operating characteristic analysis. Various cutoff values were used to determine the best predictive score. Univariate and multivariate logistic regression models compared age, PSA, free-PSA, and PCA3 score to predict prostate cancer. PCA3 cutoff 39-50 had the highest accuracy in the repeat biopsy group in which cutoff of 39 could have avoided 51.9% negative repeat biopsies, eventually missing 7.8% of cancers (all low risk); cutoff of 50 would have prevented 56.5% of negative repeat biopsies,...
To evaluate the relationship between Prostate cancer gene 3 (PCA3) score and prostate cancer as a... more To evaluate the relationship between Prostate cancer gene 3 (PCA3) score and prostate cancer as assessed by Gleason Score (GS) and pathological stage in a series of Italian patients, with elevated Prostate specific antigen (PSA) undergoing radical prostatectomy (RP). A total of 222 patients underwent RP for clinically localized prostate cancer; total PSA, free-PSA (%fPSA) and PCA3 score were collected and the possible associations among PCA3 and histological grade/pathological stage at biopsy and RP were investigated. Median PCA3 scores by GS at radical prostatectomy were 51 vs. 67 (GS <7 vs. GS ≥ 7, p=0.007), while scores at the biopsy were 56 vs. 67 (GS <7 vs. GS ≥ 7, p=0.007), and in pT2 vs. pT3 patients they were 54 vs. 80 (p=0.001). Positive digital rectal examination (DRE) (odds ratio (OR)=5.47, p=0.026), pT3 pathological stage (OR=3.68, p=0.006) and PCA3 ≥ 35 (OR=2.04, p=0.030) were the main risk factors for the presence of an aggressive disease (GS ≥ 7 at RP). PCA3 sco...
To determine if prostate cancer gene 3 (PCA3) score, Prostate Health Index (PHI), and percent fre... more To determine if prostate cancer gene 3 (PCA3) score, Prostate Health Index (PHI), and percent free prostate-specific antigen (%fPSA) may be used to differentiate prostatitis from prostate cancer (PCa), benign prostatic hyperplasia (BPH) and high-grade prostate intraepithelial neoplasia (HG-PIN) in patients with elevated PSA and negative digital rectal examination (DRE). in the present prospective study, 274 patients, undergoing PCA3 score, PHI and %fPSA assessments before initial biopsy, were enrolled. Three multivariate logistic regression models were used to test PCA3 score, PHI and %fPSA as risk factors for prostatitis vs. PCa, vs. BPH, and vs. HG-PIN. All the analyses were performed for the whole patient cohort and for the 'gray zone' of PSA (4-10 ng/ml) cohort (188 individuals). The determinants for prostatitis vs. PCa were PCA3 score, PHI and %fPSA (Odds Ratio [OR]=0.97, 0.96 and 0.94, respectively). Unit increase of PHI was the only risk factor for prostatitis vs. BPH...
We performed a head-to-head comparison of the PHI (Prostate Health Index) and PCA3. Materials and... more We performed a head-to-head comparison of the PHI (Prostate Health Index) and PCA3. Materials and Methods: We evaluated PHI and PCA3 performance in 211 patients undergoing initial (116) or repeat (95) prostate biopsy. Multivariable logistic regression analysis was done using the AUC to test the accuracy of PHI and PCA3 for predicting prostate cancer in the overall population and in each setting. Decision curve analysis was used to compare the clinical benefit of different models. Results: Overall, the AUC of the PHI (0.70) was significantly higher than the AUC of PCA3 (0.59), total prostate specific antigen (0.56) and free-to-total prostate specific antigen (0.60) (p ϭ 0.043, 0.002 and 0.037, respectively). PHI was more accurate than PCA3 for predicting prostate cancer in the initial setting (AUC 0.69 vs 0.57) and in the repeat setting (AUC 0.72 vs 0.63), although no statistically significant difference was observed. Including PCA3 in the base multivariable model (prostate specific antigen plus free-to-total prostate specific antigen plus prostate volume) did not increase predictive accuracy in either setting (AUC 0.79 vs 0.80 and 0.75 vs 0.76, respectively). Conversely, including PHI in the base multivariable model improved predictive accuracy by 5% (AUC 0.79 to 0.84) and 6% (AUC 0.75 to 0.81) in the initial and repeat prostate biopsy settings, respectively. On decision curve analysis the highest net benefit was observed when PHI was added to the base multivariable model. Conclusions: PHI and PCA3 provide a significant increase in sensitivity and specificity compared to all other examined markers and they may help guide biopsy decisions. PCA3 does not increase the accuracy of predicting prostate cancer when PHI is assessed.
A study on the effects of hyperthermia on B.N.A. induced bladder carcinomas of the dog has been c... more A study on the effects of hyperthermia on B.N.A. induced bladder carcinomas of the dog has been carried out since 1966. The hyperthermic treatment has been performed directly in the bladder using an original equipment especially designed. In a large majority of the animals definite cancericidal changes have been shown. The most favorable results were obtained in the treatment of carcinomas not infiltrating the muscular layer of the bladder. In these cases malignant recurrency was not shown up to five years after treatment. Good palliative effect is also refferred in the treatment of advanced bladder carcinoma of the man.
An experimental study by the authors, on the effects of local-regional hyperthermia on bladder B.... more An experimental study by the authors, on the effects of local-regional hyperthermia on bladder B.N.A. induced carcinoma of the dog has been going on since 1966. The authors have observed complete disappearance in the animals of the mucosa and sub-mucosa neoplasia, even after 6 years from the date of treatment. The sterilization of the neoplastic surface was checked by several histological sections observations on two excised bladders. As the results showed no negative secondary effects, the authors have started, since 1973, a clinical study of hyperthermia treatment of the bladder, vagina, female urethra and rectum stump carcinoma. Heat was obtained and introduced into the bladder by leans of an apparatus specifically designed for this purpose; the double-circuit terminal probe supplies a thermocouple controlled constant temperature. We are submitting the cases treated together with a discussion on results obtained and problems faced.
Objective: To evaluate the patterns of prescription of androgen deprivation therapy (ADT) in pati... more Objective: To evaluate the patterns of prescription of androgen deprivation therapy (ADT) in patients with prostate cancer (PCa) and the adherence to European Association Urology (EAU) guidelines for ADT prescription.
Urologic Oncology: Seminars and Original Investigations, 2015
Objective: To determine if prostate health index (PHI), prostate cancer antigen gene 3 (PCA3) sco... more Objective: To determine if prostate health index (PHI), prostate cancer antigen gene 3 (PCA3) score, and percentage of free prostatespecific antigen (%fPSA) may be used to differentiate asymptomatic acute and chronic prostatitis from prostate cancer (PCa), benign prostatic hyperplasia (BPH), and high-grade prostate intraepithelial neoplasia (HG-PIN) in patients with elevated PSA levels and negative findings on digital rectal examination at repeat biopsy (re-Bx). Patients and methods: In this prospective study, 252 patients were enrolled, undergoing PHI, PCA3 score, and %fPSA assessments before re-Bx. We used 3 multivariate logistic regression models to test the PHI, PCA3 score, and %fPSA as risk factors for prostatitis vs. PCa, vs. BPH, and vs. HG-PIN. All the analyses were performed for the whole patient cohort and for the "gray zone" of PSA (4-10 ng/ml) cohort (171 individuals). Results: Of the 252 patients, 43 (17.1%) had diagnosis of PCa. The median PHI was significantly different between men with a negative biopsy and those with a positive biopsy (34.9 vs. 48.1, P o 0.001), as for the PCA3 score (24 vs. 54, P o 0.001) and %fPSA (11.8% vs. 15.8%, P ¼ 0.012). The net benefit of using PCA3 and PHI to differentiate prostatitis and PCa was moderate, although it extended to a good range of threshold probabilities (40%-100%), whereas that from using %fPSA was negligible: this pattern was reported for the whole population as for the "gray zone" PSA cohort. Conclusion: In front of a good diagnostic performance of all the 3 biomarkers in distinguishing negative biopsy vs. positive biopsy, the clinical benefit of using the PCA3 score and PHI to estimate prostatitis vs. PCa was comparable. PHI was the only determinant for prostatitis vs. BPH, whereas no biomarkers could differentiate prostate inflammation from HG-PIN.
To evaluate pathological patterns of prostate biopsy in men with changes in risk class by prostat... more To evaluate pathological patterns of prostate biopsy in men with changes in risk class by prostate cancer gene 3 (PCA3) score and with elevated serum prostate-specific antigen (PSA) or positive digital rectal examination (DRE), undergoing a repeat biopsy. A total of 108 males of two Italian Institutions who had undergone at least two PCA3 score assessments with changed PCA3 risk class were selected. Comparison of PCA3 score in patients with negative re-biopsy [normal parenchyma, benign prostatic hyperplasia (BPH), chronic prostatitis, high-grade prostate intraepithelial neoplasia (HG-PIN), atypical small acinar prostate (ASAP)] or positive re-biopsy was performed. The up- and down-grading rates for PCA3 score were 71.3% (n=77) and 28.7% (n=31), respectively. Among the 77 up-graded patients, the median change in PCA3 score was 24 (range=4-69), while among the 31 down-graded ones, the median change was 17 (2 to 55). The PCA3 score in 24 out of 29 (82.7%) patients with prostate cancer ...
Analytical and quantitative cytology and histology / the International Academy of Cytology [and] American Society of Cytology, 2012
To determine an optimal prostate cancer gene 3 (PCA3) cutoff in predicting prostate cancer in Ita... more To determine an optimal prostate cancer gene 3 (PCA3) cutoff in predicting prostate cancer in Italian patients undergoing first or repeat biopsy. In this observational multicenter study 1246 men with elevated prostate specific antigen (PSA) and negative digital rectal examination, with prostate biopsy after PCA3 assessment, were divided into two groups submitted to PCA3 testing before or after previous negative biopsies. Ideal PCA3 cutoff was identified using area under the curve of the receiver operating characteristic analysis. Various cutoff values were used to determine the best predictive score. Univariate and multivariate logistic regression models compared age, PSA, free-PSA, and PCA3 score to predict prostate cancer. PCA3 cutoff 39-50 had the highest accuracy in the repeat biopsy group in which cutoff of 39 could have avoided 51.9% negative repeat biopsies, eventually missing 7.8% of cancers (all low risk); cutoff of 50 would have prevented 56.5% of negative repeat biopsies,...
To evaluate the relationship between Prostate cancer gene 3 (PCA3) score and prostate cancer as a... more To evaluate the relationship between Prostate cancer gene 3 (PCA3) score and prostate cancer as assessed by Gleason Score (GS) and pathological stage in a series of Italian patients, with elevated Prostate specific antigen (PSA) undergoing radical prostatectomy (RP). A total of 222 patients underwent RP for clinically localized prostate cancer; total PSA, free-PSA (%fPSA) and PCA3 score were collected and the possible associations among PCA3 and histological grade/pathological stage at biopsy and RP were investigated. Median PCA3 scores by GS at radical prostatectomy were 51 vs. 67 (GS <7 vs. GS ≥ 7, p=0.007), while scores at the biopsy were 56 vs. 67 (GS <7 vs. GS ≥ 7, p=0.007), and in pT2 vs. pT3 patients they were 54 vs. 80 (p=0.001). Positive digital rectal examination (DRE) (odds ratio (OR)=5.47, p=0.026), pT3 pathological stage (OR=3.68, p=0.006) and PCA3 ≥ 35 (OR=2.04, p=0.030) were the main risk factors for the presence of an aggressive disease (GS ≥ 7 at RP). PCA3 sco...
To determine if prostate cancer gene 3 (PCA3) score, Prostate Health Index (PHI), and percent fre... more To determine if prostate cancer gene 3 (PCA3) score, Prostate Health Index (PHI), and percent free prostate-specific antigen (%fPSA) may be used to differentiate prostatitis from prostate cancer (PCa), benign prostatic hyperplasia (BPH) and high-grade prostate intraepithelial neoplasia (HG-PIN) in patients with elevated PSA and negative digital rectal examination (DRE). in the present prospective study, 274 patients, undergoing PCA3 score, PHI and %fPSA assessments before initial biopsy, were enrolled. Three multivariate logistic regression models were used to test PCA3 score, PHI and %fPSA as risk factors for prostatitis vs. PCa, vs. BPH, and vs. HG-PIN. All the analyses were performed for the whole patient cohort and for the 'gray zone' of PSA (4-10 ng/ml) cohort (188 individuals). The determinants for prostatitis vs. PCa were PCA3 score, PHI and %fPSA (Odds Ratio [OR]=0.97, 0.96 and 0.94, respectively). Unit increase of PHI was the only risk factor for prostatitis vs. BPH...
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