Effect of Triptorelin (Decapeptyl®) 22.5 mg on Two Biomarkers in Patients With Advanced Prostate Cancer

Overview

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.

Full Title of Study: “Prostate Cancer Antigen-3 (PCA-3) and TMPRSS2-ERG (T2-ERG) Score Changes During Initiation of Androgen Deprivation Therapy (ADT) With Triptorelin 22.5mg in Patients With Advanced Prostate Cancer (PCA): A Phase III, Single Arm Multicentre Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2011

Interventions

  • Drug: Triptorelin (Decapeptyl®)
    • One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.

Arms, Groups and Cohorts

  • Experimental: Triptorelin (Decapeptyl®) 22.5 mg

Clinical Trial Outcome Measures

Primary Measures

  • PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA
    • Time Frame: At month 6 post-treatment
    • 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

Secondary Measures

  • PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA
    • Time Frame: At month 1 and 3 post-treatment
    • 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
  • TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)
    • Time Frame: At baseline, month 1, 3 and 6 post-treatment
    • 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.’
  • 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)

Participating in This Clinical Trial

Inclusion Criteria

  • A histologically confirmed, locally advanced or metastatic prostate cancer, and naïve to androgen deprivation therapy, and a candidate for hormonal treatment. – An estimated survival time of at least twelve months according to the investigator's assessment. – A performance status score ≤ 2 according to the World Health Organisation (WHO) criteria. Exclusion Criteria:

  • Previous surgical castration. – Previous or has planned curative prostate cancer therapy (radiation/surgery) – Previous hormone therapy (GnRH analogues, estrogens or anti-androgens) – Patients with risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or significant obstructive uropathy)

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ipsen
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ipsen Medical Director, Study Director, Ipsen

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