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851 Lower PCA3 scores in prostate cancer patients with metastatic disease than in patients with non-metastatic disease: Baseline data from the Triptocare study
851
Lower PCA3 scores in prostate cancer patients with metastatic disease than in patients with non-metastatic disease: Baseline data from the Triptocare study Eur Urol Suppl 2013;12;e851
Martínez-Piñeiro L.1, Schalken J.2, De La Taille A.3 1
Hospital Universitario Infanta Sofia, Dept. of Urology, Madrid, Spain, 2Radboud University, Nijmegen Medical Centre,
Dept. of Experimental Urology, Nijmegen, The Netherlands, 3Henri Mondor Hospital, Dept. of Urology, Creteil, France INTRODUCTION & OBJECTIVES: PCA3 and TMPRSS2-ERG scores are potentially useful biomarkers for the diagnosis and prognosis of prostate cancer, respectively. In this analysis, baseline data from the Triptocare study were used to assess the expression of these markers in patient-groups defined by disease characteristics. MATERIAL & METHODS: The Triptocare study was a prospective, open-label, multicentre, single-arm, Phase III study of a single intramuscular dose of triptorelin 22.5 mg (6-month formulation) in men with locally-advanced or metastatic prostate cancer who were naive to androgen deprivation therapy. This analysis included only baseline data (7–14 days before triptorelin administration). The relationship between PCA3 score and TMPRSS2-ERG score (calculated from measurement of PSA, PCA3 and TMPRSS2-ERG mRNA in urine after a digital rectal examination) with measures of disease severity, including Gleason score, PSA level and metastasis status, was analysed. Statistical significance was assessed using 95% confidence intervals of the medians for continuous variables (using order statistics) and the proportions for categorical variables (Wald test) for differences between groups. RESULTS: The ITT population comprised 322 patients; 283 had assessable PCA3 scores at baseline and 289 had assessable TMPRSS2-ERG scores. The PCA3 scores were significantly higher in patients aged ≥65 years than in patients aged <65 years and in patients with serum PSA level <100 μg/l than in patients with serum PSA >200 μg/l, and were significantly lower in patients with metastasis than in patients with no metastasis or unknown metastasis status. By contrast, there was no significant relationship between PCA3 score and Gleason score. A positive TMPRSS2-ERG score was defined as ≥35; age, presence of metastasis, PSA level and Gleason score were not associated with a significant difference in the proportion of TMPRSS2-ERG-positive scores. CONCLUSIONS: PCA3 scores were significantly lower in patients with metastatic disease than in patients with no metastasis, and there was no obvious relationship between TMPRSS2-ERG score and grade of cancer in this study population. These findings indicate that PCA3 and TMPRSS2-ERG scores may not be appropriate biomarkers to assess the initial seriousness or aggressiveness of metastatic prostate cancer. However, further studies are needed to elucidate any potential role for these biomarkers in advanced disease and the impact of androgen deprivation therapy. Follow-up results from the Triptocare study may help address these issues.
Lower PCA3 scores in prostate cancer patients with metastatic disease than in patients with non-metastatic disease: Baseline data from the Triptocare study Eur Urol Suppl 2013;12;e851
Martínez-Piñeiro L.1, Schalken J.2, De La Taille A.3 1
Hospital Universitario Infanta Sofia, Dept. of Urology, Madrid, Spain, 2Radboud University, Nijmegen Medical Centre,
Dept. of Experimental Urology, Nijmegen, The Netherlands, 3Henri Mondor Hospital, Dept. of Urology, Creteil, France INTRODUCTION & OBJECTIVES: PCA3 and TMPRSS2-ERG scores are potentially useful biomarkers for the diagnosis and prognosis of prostate cancer, respectively. In this analysis, baseline data from the Triptocare study were used to assess the expression of these markers in patient-groups defined by disease characteristics. MATERIAL & METHODS: The Triptocare study was a prospective, open-label, multicentre, single-arm, Phase III study of a single intramuscular dose of triptorelin 22.5 mg (6-month formulation) in men with locally-advanced or metastatic prostate cancer who were naive to androgen deprivation therapy. This analysis included only baseline data (7–14 days before triptorelin administration). The relationship between PCA3 score and TMPRSS2-ERG score (calculated from measurement of PSA, PCA3 and TMPRSS2-ERG mRNA in urine after a digital rectal examination) with measures of disease severity, including Gleason score, PSA level and metastasis status, was analysed. Statistical significance was assessed using 95% confidence intervals of the medians for continuous variables (using order statistics) and the proportions for categorical variables (Wald test) for differences between groups. RESULTS: The ITT population comprised 322 patients; 283 had assessable PCA3 scores at baseline and 289 had assessable TMPRSS2-ERG scores. The PCA3 scores were significantly higher in patients aged ≥65 years than in patients aged <65 years and in patients with serum PSA level <100 μg/l than in patients with serum PSA >200 μg/l, and were significantly lower in patients with metastasis than in patients with no metastasis or unknown metastasis status. By contrast, there was no significant relationship between PCA3 score and Gleason score. A positive TMPRSS2-ERG score was defined as ≥35; age, presence of metastasis, PSA level and Gleason score were not associated with a significant difference in the proportion of TMPRSS2-ERG-positive scores. CONCLUSIONS: PCA3 scores were significantly lower in patients with metastatic disease than in patients with no metastasis, and there was no obvious relationship between TMPRSS2-ERG score and grade of cancer in this study population. These findings indicate that PCA3 and TMPRSS2-ERG scores may not be appropriate biomarkers to assess the initial seriousness or aggressiveness of metastatic prostate cancer. However, further studies are needed to elucidate any potential role for these biomarkers in advanced disease and the impact of androgen deprivation therapy. Follow-up results from the Triptocare study may help address these issues.