Clinical trial NCT01020448: Effect of Triptorelin (Decapeptyl®) 22.5 mg on Two Biomarkers in Patients With Advanced Prostate Cancer
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Locally advanced or metastatic Prostate Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2009-11-25
Enrollment: 339
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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)

Primary outcomes:
measure: PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA
timeFrame: At month 6 post-treatment
Secondary outcomes:
measure: PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA
timeFrame: At month 1 and 3 post-treatment
measure: TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)
timeFrame: At baseline, month 1, 3 and 6 post-treatment
measure: Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL)
timeFrame: At month 1, 3 and 6 post-treatment
measure: PSA Level
timeFrame: At baseline, month 1, 3 and 6 post-treatment
measure: Safety, Assessed Through the Collection of Adverse Events (AEs)
timeFrame: For the duration of the study (up to month 6)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hôpital Erasme
city: Brussels
country: Belgium
facility: UZ Brussels
city: Brussels
country: Belgium
facility: UCL Saint-Luc
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHU de Liège
city: Fredericia
country: Denmark
facility: Fredericia Sygehus
city: Frederiksberg
country: Denmark
facility: Frederiksbergs Hospital
city: Herlev
country: Denmark
facility: Herlev University Hospital
city: Odense
country: Denmark
facility: Odense Universitets hospital
city: Avignon
country: France
facility: Clinique Rhône Durance
city: Bordeaux
country: France
facility: Hôpital Pellegrin
city: Créteil
country: France
facility: CHU Henri Mondor
city: Grenoble
country: France
facility: CHU Michalon
city: Lille
country: France
facility: Chru Lille
city: Marseille
country: France
facility: Hôpital Nord
city: Montpellier
country: France
facility: Clinique Beau Soleil
city: Nancy
country: France
facility: Private practice
city: Nantes
country: France
facility: CHU Nantes
city: Nice
country: France
facility: CHU Pasteur
city: Paris
country: France
facility: Hôpital Val de Grâce
city: Paris
country: France
facility: Institut Mutualiste Monsouris
city: Saint Genis Laval
country: France
facility: Hôpital Henry Gabrielle
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulouse
country: France
facility: CHU Toulouse
city: Milano
country: Italy
facility: IRCCS Fondazione S. Raffaele del Monte Tabor
city: Torino
country: Italy
facility: AOU San Luigi Gonzaga
city: Riga
country: Latvia
facility: P.Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Center of Oncology
city: Kaunas
country: Lithuania
facility: Medical University Clinics
city: Klaipeda
country: Lithuania
facility: University Hospital
city: Vilnius
country: Lithuania
facility: University Oncological Institute
city: Amstelveen
country: Netherlands
facility: Ziekenhuis Amstelland
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Leiden
country: Netherlands
facility: Diaconessenhuis
city: Sneek
country: Netherlands
facility: Antonius Ziekenhuis
city: Arad
country: Romania
facility: Medical Center
city: Bucharest
country: Romania
facility: Oncology Institute
city: Cluj Napoca
country: Romania
facility: Sc E-Uro Srl
city: Timisoara
country: Romania
facility: Oncomed
city: Barcelona
country: Spain
facility: Hospital Valle Hebrón
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Coruña
country: Spain
facility: Hospital Juan Canalejo
city: Madrid
country: Spain
facility: Hospital General Universitario
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Infanta Sofía
city: Valencia
country: Spain
facility: Instituto de Oncología
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital Wales
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
city: Derby
country: United Kingdom
facility: Derby City Hosptial
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
city: Falkirk
country: United Kingdom
facility: Falkirk & District Royal Infirmary
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Stevenage
country: United Kingdom
facility: Lister Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: