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

January 11, 2019 updated by: Ipsen

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

339

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Hopital Erasme
      • Brussels, Belgium, 1090
        • UZ Brussels
      • Brussels, Belgium, 1200
        • UCL Saint-Luc
      • Edegem, Belgium, 2650
        • UZ Antwerpen
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liège, Belgium, 4000
        • CHU de Liege
  • Denmark
      • Fredericia, Denmark
        • Fredericia Sygehus
      • Frederiksberg, Denmark, 2000
        • Frederiksbergs Hospital
      • Herlev, Denmark, 2730
        • Herlev University Hospital
      • Odense, Denmark, 5000
        • Odense Universitets Hospital
  • France
      • Avignon, France, 84000
        • Clinique Rhône Durance
      • Bordeaux, France, 33076
        • Hôpital Pellegrin
      • Créteil, France, 94010
        • CHU Henri Mondor
      • Grenoble, France, 38043
        • CHU Michalon
      • Lille, France, 59037
        • CHRU Lille
      • Marseille, France, 13915
        • Hopital Nord
      • Montpellier, France, 34000
        • Clinique Beau Soleil
      • Nancy, France, 54100
        • Private Practice
      • Nantes, France, 44093
        • CHU Nantes
      • Nice, France, 06002
        • Chu Pasteur
      • Paris, France, 75005
        • Hopital Val de GRACE
      • Paris, France, 75014
        • Institut Mutualiste Monsouris
      • Saint Genis Laval, France, 69230
        • Hôpital Henry Gabrielle
      • Suresnes, France, 92150
        • Hopital Foch
      • Toulouse, France, 31059
        • CHU Toulouse
  • Italy
      • Milano, Italy, 20132
        • IRCCS Fondazione S. Raffaele del Monte Tabor
      • Torino, Italy, 10043
        • AOU San Luigi Gonzaga
  • Latvia
      • Riga, Latvia, LV 1002
        • P.Stradins Clinical University Hospital
      • Riga, Latvia, LV1079
        • Center of oncology
  • Lithuania
      • Kaunas, Lithuania, LT-50009
        • Medical University Clinics
      • Klaipeda, Lithuania
        • University Hospital
      • Vilnius, Lithuania, LT-08660
        • University Oncological Institute
  • Netherlands
      • Amstelveen, Netherlands
        • Ziekenhuis Amstelland
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum
      • Leiden, Netherlands, 2333ZA
        • Diaconessenhuis
      • Sneek, Netherlands
        • Antonius Ziekenhuis
  • Romania
      • Arad, Romania
        • Medical Center
      • Bucharest, Romania, 72435
        • Oncology Institute
      • Cluj Napoca, Romania
        • Sc E-Uro Srl
      • Timisoara, Romania
        • Oncomed
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic
      • Barcelona, Spain, 08035
        • Hospital Valle Hebrón
      • Bilbao, Spain, 48013
        • Hospital de Basurto
      • Coruña, Spain, 15006
        • Hospital Juan Canalejo
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Madrid, Spain, 28007
        • Hospital General Universitario
      • Madrid, Spain, 28702
        • Hospital Infanta Sofia
      • Valencia, Spain, 46009
        • Instituto de Oncología
  • United Kingdom
      • Bristol, United Kingdom
        • Bristol Royal Infirmary
      • Cambridge, United Kingdom, CB2 8RP
        • Addenbrookes Hospital
      • Cardiff, United Kingdom, CF14 4XW
        • University Hospital Wales
      • Coventry, United Kingdom, CV3 / CV2 2DX
        • University Hospital Coventry
      • Derby, United Kingdom, DE22 3NE
        • Derby City Hosptial
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital
      • Falkirk, United Kingdom, FK1 5QE
        • Falkirk & District Royal Infirmary
      • Leicester, United Kingdom, LE5 4PW
        • Leicester General Hospital
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham City Hospital
      • Stevenage, United Kingdom, SG1 4AB
        • Lister Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Triptorelin (Decapeptyl®) 22.5 mg
Drug: Triptorelin (Decapeptyl®)
One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At month 6 post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At month 1 and 3 post-treatment
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.'
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
At month 1, 3 and 6 post-treatment
PSA Level
Time Frame: At baseline, month 1, 3 and 6 post-treatment
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)
For the duration of the study (up to month 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

November 24, 2009

First Submitted That Met QC Criteria

November 24, 2009

First Posted (ESTIMATE)

November 25, 2009

Study Record Updates

Last Update Posted (ACTUAL)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8-79-52014-168
  • 2009-012786-58 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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