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OpenTrials
Completed

NCT Number: NCT01020448

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Erasme, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Triptorelin (Decapeptyl®)

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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.'

  3. 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

  4. PSA Level

    Time frame: At baseline, month 1, 3 and 6 post-treatment

  5. Safety, Assessed Through the Collection of Adverse Events (AEs)

    Time frame: For the duration of the study (up to month 6)

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

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

Acronym: Triptocare

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Nov 25, 2009
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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