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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Triptorelin (Decapeptyl®)
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Locally advanced or metastatic Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Hôpital Erasme
  • UZ Brussels
  • UCL Saint-Luc
  • UZ Antwerpen
  • UZ Leuven
  • CHU de Liège
  • Fredericia Sygehus
  • Frederiksbergs Hospital
  • Herlev University Hospital
  • Odense Universitets hospital
  • Clinique Rhône Durance
  • Hôpital Pellegrin
  • CHU Henri Mondor
  • CHU Michalon
  • Chru Lille
  • Hôpital Nord
  • Clinique Beau Soleil
  • Private practice
  • CHU Nantes
  • CHU Pasteur
  • Hôpital Val de Grâce
  • Institut Mutualiste Monsouris
  • Hôpital Henry Gabrielle
  • Hôpital Foch
  • CHU Toulouse
  • IRCCS Fondazione S. Raffaele del Monte Tabor
  • AOU San Luigi Gonzaga
  • P.Stradins Clinical University Hospital
  • Center of Oncology
  • Medical University Clinics
  • University Hospital
  • University Oncological Institute
  • Ziekenhuis Amstelland
  • Academisch Medisch Centrum
  • Diaconessenhuis
  • Antonius Ziekenhuis
  • Medical Center
  • Oncology Institute
  • Sc E-Uro Srl
  • Oncomed
  • Hospital Valle Hebrón
  • Hospital Clinic
  • Hospital de Basurto
  • Hospital Juan Canalejo
  • Hospital General Universitario
  • Hospital 12 de Octubre
  • Hospital Infanta Sofía
  • Instituto de Oncología
  • Bristol Royal Infirmary
  • Addenbrookes Hospital
  • University Hospital Wales
  • University Hospital Coventry
  • Derby City Hosptial
  • Royal Devon and Exeter Hospital
  • Falkirk & District Royal Infirmary
  • Leicester General Hospital
  • Freeman Hospital
  • Nottingham City Hospital
  • Lister Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Triptorelin (Decapeptyl®) 22.5 mg

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.'
Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL)
PSA Level
Safety, Assessed Through the Collection of Adverse Events (AEs)

Full Information

First Posted
November 24, 2009
Last Updated
January 11, 2019
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT01020448
Brief Title
Effect of Triptorelin (Decapeptyl®) 22.5 mg on Two Biomarkers in Patients With Advanced Prostate Cancer
Acronym
Triptocare
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Locally advanced or metastatic Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
339 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Triptorelin (Decapeptyl®) 22.5 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Triptorelin (Decapeptyl®)
Intervention Description
One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
Primary Outcome Measure Information:
Title
PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA
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
Time Frame
At month 6 post-treatment
Secondary Outcome Measure Information:
Title
PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA
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
Time Frame
At month 1 and 3 post-treatment
Title
TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)
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.'
Time Frame
At baseline, month 1, 3 and 6 post-treatment
Title
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
Title
PSA Level
Time Frame
At baseline, month 1, 3 and 6 post-treatment
Title
Safety, Assessed Through the Collection of Adverse Events (AEs)
Time Frame
For the duration of the study (up to month 6)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UZ Brussels
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
UCL Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Fredericia Sygehus
City
Fredericia
Country
Denmark
Facility Name
Frederiksbergs Hospital
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Facility Name
Herlev University Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Odense Universitets hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Clinique Rhône Durance
City
Avignon
ZIP/Postal Code
84000
Country
France
Facility Name
Hôpital Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHU Michalon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Chru Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Nord
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
Clinique Beau Soleil
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Private practice
City
Nancy
ZIP/Postal Code
54100
Country
France
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU Pasteur
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
Hôpital Val de Grâce
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Institut Mutualiste Monsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hôpital Henry Gabrielle
City
Saint Genis Laval
ZIP/Postal Code
69230
Country
France
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
Facility Name
CHU Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
IRCCS Fondazione S. Raffaele del Monte Tabor
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
AOU San Luigi Gonzaga
City
Torino
ZIP/Postal Code
10043
Country
Italy
Facility Name
P.Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV 1002
Country
Latvia
Facility Name
Center of Oncology
City
Riga
ZIP/Postal Code
LV1079
Country
Latvia
Facility Name
Medical University Clinics
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
University Hospital
City
Klaipeda
Country
Lithuania
Facility Name
University Oncological Institute
City
Vilnius
ZIP/Postal Code
LT-08660
Country
Lithuania
Facility Name
Ziekenhuis Amstelland
City
Amstelveen
Country
Netherlands
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Diaconessenhuis
City
Leiden
ZIP/Postal Code
2333ZA
Country
Netherlands
Facility Name
Antonius Ziekenhuis
City
Sneek
Country
Netherlands
Facility Name
Medical Center
City
Arad
Country
Romania
Facility Name
Oncology Institute
City
Bucharest
ZIP/Postal Code
72435
Country
Romania
Facility Name
Sc E-Uro Srl
City
Cluj Napoca
Country
Romania
Facility Name
Oncomed
City
Timisoara
Country
Romania
Facility Name
Hospital Valle Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital Juan Canalejo
City
Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital General Universitario
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Infanta Sofía
City
Madrid
ZIP/Postal Code
28702
Country
Spain
Facility Name
Instituto de Oncología
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Bristol Royal Infirmary
City
Bristol
Country
United Kingdom
Facility Name
Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 8RP
Country
United Kingdom
Facility Name
University Hospital Wales
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
University Hospital Coventry
City
Coventry
ZIP/Postal Code
CV3 / CV2 2DX
Country
United Kingdom
Facility Name
Derby City Hosptial
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Falkirk & District Royal Infirmary
City
Falkirk
ZIP/Postal Code
FK1 5QE
Country
United Kingdom
Facility Name
Leicester General Hospital
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Lister Hospital
City
Stevenage
ZIP/Postal Code
SG1 4AB
Country
United Kingdom

12. IPD Sharing Statement

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

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