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Evaluation of urinary prostate cancer antigen‐3 ( PCA 3) and TMPRSS 2‐ ERG score changes when starting androgen‐deprivation therapy with triptorelin 6‐month formulation in patients with locally advanced and metastatic prostate cancer
Author(s) -
MartínezPiñeiro Luis,
Schalken Jack A.,
Cabri Patrick,
Maisonobe Pascal,
Taille Alexandre
Publication year - 2014
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/bju.12542
Subject(s) - medicine , prostate cancer , triptorelin , androgen deprivation therapy , prostate specific antigen , urology , hazard ratio , population , cancer , prospective cohort study , confidence interval , oncology , gynecology , hormone , gonadotropin releasing hormone , environmental health , luteinizing hormone
Objective To assess prostate cancer antigen‐3 ( PCA 3) and TMPRSS 2‐ ERG scores in patients with advanced and metastatic prostate cancer at baseline and after 6 months of treatment with triptorelin 22.5 mg, and analyse these scores in patient‐groups defined by different disease characteristics. Patients and Methods The T riptocare study was a prospective, open‐label, multicentre, single‐arm, P hase III study of triptorelin 22.5 mg in men with locally advanced or metastatic prostate cancer, who were naïve to androgen‐deprivation therapy ( ADT ). The primary objective was to model the urinary PCA 3 change at 6 months, according to baseline variables. Other outcome measures included urinary PCA 3 and TMPRSS 2‐ ERG scores and statuses, and serum testosterone and prostate‐specific antigen ( PSA ) levels at baseline and at 1, 3 and 6 months after initiation of ADT . Safety was assessed by recording adverse events and changes in laboratory parameters. Results The intent‐to‐treat population comprised 322 patients; 39 (12.1%) had non‐assessable PCA 3 scores at baseline, and 109/322 (33.9%), 215/313 (68.7%) and 232/298 (77.9%) had non‐assessable PCA 3 scores at 1, 3 and 6 months, respectively. Baseline G leason score was the only variable associated with non‐assessability of PCA 3 score at 6 months ( P = 0.017) – the hazard of having a non‐assessable PCA 3 score at 6 months was 1.824‐fold higher (95% confidence interval 1.186–2.805) in patients with a G leason score ≥8 vs those with a G leason score ≤6. The median PCA 3 scores at baseline were significantly higher in patients aged ≥65 years vs those aged <65 years and in patients with a serum PSA level <100 ng/mL vs those with serum PSA level of >200 ng/mL. The median PCA 3 score was significantly lower in patients with metastasis than in patients with no metastasis or unknown metastasis status. TMPRSS 2‐ ERG scores ≥35 were considered positive ( n = 149 [51.6%]). Age, presence of metastasis, PSA level and G leason score at baseline were not associated with a significant difference in the proportion of TMPRSS 2‐ ERG ‐positive scores. The median serum PSA levels decreased from 45.5 ng/mL at baseline to 1.2 ng/mL after 6 months, and as expected, >90% of patients achieved castrate levels of testosterone (<50 ng/dL) at 1, 3, and 6 months during triptorelin treatment. The safety profile reported from this study is consistent with the known safety profile of triptorelin. Conclusion These data from the T riptocare study suggest that urinary PCA 3 or TMPRSS 2‐ ERG score are not reliable markers of cancer stage in advanced prostate cancer. Urinary PCA 3 and TMPRSS 2‐ ERG scores do not appear to be useful in assessing response to ADT in advanced prostate cancer, with most patients having non‐assessable scores after 6 months of treatment.