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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
339

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Hôpital 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
        • Hôpital 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 Clinic
      • 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 Sofía
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2009

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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