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

Purpose

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 T2- ERG), in patients with histologically confirmed and advanced stages of prostate cancer. Their characteristics according to risk factors such as PSA, Gleason score will be determined at baseline and 1, 3 and 6 month post-treatment.

Condition	Intervention	Phase
Prostate Cancer	Drug: Triptorelin (Decapeptyl®)	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Triptorelin pamoate

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:

PCA3 score expressed as a ratio of PCA3 mRNA (messenger ribonucleic acid) over PSA (prostate specific antigen) mRNA. [ Time Frame: 6 months post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PCA3 score expressed as a ratio of PCA3 mRNA over PSA mRNA. [ Time Frame: 1 month and at 3 months post-treatment ] [ Designated as safety issue: No ]
TMPRSS2-ERG score (expressed as a ratio of T2-ERG mRNA over PSA mRNA). [ Time Frame: 1, 3 and 6 months post-treatment ] [ Designated as safety issue: No ]
Proportion of patients medically castrated (i.e. with serum testosterone levels of <50 ng/dL). [ Time Frame: 1, 3 and 6 months post-treatment ] [ Designated as safety issue: No ]
PSA level change. [ Time Frame: From baseline to 1, 3 and 6 months post-treatment ] [ Designated as safety issue: No ]
Safety, assessed through the collection of adverse events (AEs). [ Time Frame: For the duration of the study ] [ Designated as safety issue: Yes ]

Enrollment:	339
Study Start Date:	November 2009
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01020448

Hide Study Locations

Locations

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

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Patrick Cabri, M.D.

Ipsen

More Information

No publications provided

Responsible Party:	Ipsen
ClinicalTrials.gov Identifier:	NCT01020448 History of Changes
Other Study ID Numbers:	8-79-52014-168, 2009-012786-58
Study First Received:	November 24, 2009
Last Updated:	April 23, 2013
Health Authority:	Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Denmark: Danish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Italy: Ethics Committee Latvia: State Agency of Medicines Lithuania: State Medicine Control Agency - Ministry of Health Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Romania: National Medicines Agency Spain: Spanish Agency of Medicines United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Ipsen:

Locally advanced or metastatic Prostate Cancer

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Triptorelin
Luteolytic Agents

Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 21, 2013

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