Skip to content

Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name Triptocare

NCTNCT01020448 (opens ClinicalTrials.gov in a new tab)Other id8-79-52014-168Other id2009-012786-58Other id2009
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
339 participants (actual)
Sponsor
Ipsen · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
10 countries

Belgium, Denmark, France, Italy, Latvia, Lithuania, Netherlands, Romania, Spain, United Kingdom

Start
Nov 2009
Primary completion
Nov 2011
Completion
Jun 2013
First posted
25 Nov 2009 (estimated)
Last update posted
30 Jan 2019
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200920102011201220132014
  1. Ph 3

    Triptocare

    NCT01020448

    Nov 2009 to Jun 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Triptorelin (Decapeptyl®)Drug

Arms1

  • Experimental

    Triptorelin (Decapeptyl®) 22.5 mg

Primary outcomes1

Outcomes the sponsor listed as primary.

  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

    Registry description

    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(5)

  1. PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA

    Time frame · At month 1 and 3 post-treatment

    Registry description

    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

    Registry description

    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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· At month 6 post-treatment

PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA

GroupValue (participants)
Triptorelin (Decapeptyl®) 22.5 mg232
Secondary and other outcome results(5)
Secondary outcomeNumber· At month 1 and 3 post-treatment

PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA

GroupValue (participants)
Triptorelin (Decapeptyl®) 22.5 mg109
Secondary outcomeNumber· At baseline, month 1, 3 and 6 post-treatment

TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)

GroupValue (participants)
Triptorelin (Decapeptyl®) 22.5 mg33
Secondary outcomeNumber· At month 1, 3 and 6 post-treatment

Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL)

GroupValue (percentage of participants)
Triptorelin (Decapeptyl®) 22.5 mg94.7
Secondary outcomeMedian· At baseline, month 1, 3 and 6 post-treatment

PSA Level

GroupValue (μg/L)
Triptorelin (Decapeptyl®) 22.5 mg45.4
Secondary outcomeNumber· For the duration of the study (up to month 6)

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

GroupValue (participants)
Triptorelin (Decapeptyl®) 22.5 mg193

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Triptorelin (Decapeptyl®) 22.5 mgTriptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.–37 / 32589 / 325

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

PepBank is a research reference. Talk to a doctor before you use any peptide.