The purpose of this study is to evaluate the effect of an initial hormonal treatment gonadotrophin-releasing hormone (GnRH Agonist) on 2 biomarkers (PCA3 and TMPRSS2-ERG), in patients with histologically confirmed and advanced stages of prostate cancer. Their characteristics, according to risk factors such as PSA and Gleason score will be determined at baseline and 1, 3 and 6 month post-treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
339
One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA
PCA-3 score = (mRNA PCA3/mRNA PSA)x1000 * Non-assessable = Associated PSA mRNA \<7500 copies/mL * ≤BLQ = PCA-3 mRNA is below the concentration of the calibrator and associated PSA mRNA \>7500 copies/mL * \<35 = PCA-3 mRNA above BLQ and less than 35 * ≥35 = PCA-3 mRNA greater or equal to 35
Time frame: At month 6 post-treatment
PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA
PCA-3 score = (mRNA PCA3/mRNA PSA)x1000 * Non-assessable = Associated PSA mRNA \<7500 copies/mL * ≤BLQ = PCA-3 mRNA is below the concentration of the calibrator and associated PSA mRNA \>7500 copies/mL * \<35 = PCA-3 mRNA above BLQ and less than 35 * ≥35 = PCA-3 mRNA greater or equal to 35
Time frame: At month 1 and 3 post-treatment
TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)
TMPRSS2-ERG = (TMPRSS2-ERG mRNA / PSA mRNA) x 100000 A TMPRSS2-ERG score \<35 was described as 'negative' and a TMPRSS2-ERG score ≥35 as 'positive.'
Time frame: At baseline, month 1, 3 and 6 post-treatment
Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL)
Time frame: At month 1, 3 and 6 post-treatment
PSA Level
Time frame: At baseline, month 1, 3 and 6 post-treatment
Safety, Assessed Through the Collection of Adverse Events (AEs)
Time frame: For the duration of the study (up to month 6)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hôpital Erasme
Brussels, Belgium
UZ Brussels
Brussels, Belgium
UCL Saint-Luc
Brussels, Belgium
UZ Antwerpen
Edegem, Belgium
UZ Leuven
Leuven, Belgium
CHU de Liège
Liège, Belgium
Fredericia Sygehus
Fredericia, Denmark
Frederiksbergs Hospital
Frederiksberg, Denmark
Herlev University Hospital
Herlev, Denmark
Odense Universitets hospital
Odense, Denmark
...and 49 more locations