Effect of Triptorelin (Decapeptyl®) 22.5 mg on Two Biomarkers in Patients With Advanced Prostate Cancer
- Registration Number
- NCT01020448
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 339
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Triptorelin (Decapeptyl®) 22.5 mg Triptorelin (Decapeptyl®) -
- Primary Outcome Measures
Name Time Method PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA 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
- Secondary Outcome Measures
Name Time Method PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA 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 35TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA) 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.'PSA Level At baseline, month 1, 3 and 6 post-treatment Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL) At month 1, 3 and 6 post-treatment Safety, Assessed Through the Collection of Adverse Events (AEs) For the duration of the study (up to month 6)
Trial Locations
- Locations (59)
Hospital Juan Canalejo
🇪🇸Coruña, Spain
Lister Hospital
🇬🇧Stevenage, United Kingdom
Hôpital Pellegrin
🇫🇷Bordeaux, France
CHU Nantes
🇫🇷Nantes, France
University Hospital Wales
🇬🇧Cardiff, United Kingdom
Hospital de Basurto
🇪🇸Bilbao, Spain
IRCCS Fondazione S. Raffaele del Monte Tabor
🇮🇹Milano, Italy
Clinique Rhône Durance
🇫🇷Avignon, France
CHU Henri Mondor
🇫🇷Créteil, France
CHU Michalon
🇫🇷Grenoble, France
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hôpital Val de Grâce
🇫🇷Paris, France
Institut Mutualiste Monsouris
🇫🇷Paris, France
Hospital Valle Hebrón
🇪🇸Barcelona, Spain
AOU San Luigi Gonzaga
🇮🇹Torino, Italy
Private practice
🇫🇷Nancy, France
Hôpital Foch
🇫🇷Suresnes, France
Bristol Royal Infirmary
🇬🇧Bristol, United Kingdom
Freeman Hospital
🇬🇧Newcastle upon Tyne, United Kingdom
Hospital Infanta Sofía
🇪🇸Madrid, Spain
Hospital Clinic
🇪🇸Barcelona, Spain
UCL Saint-Luc
🇧🇪Brussels, Belgium
Center of Oncology
🇱🇻Riga, Latvia
Chru Lille
🇫🇷Lille, France
Hôpital Nord
🇫🇷Marseille, France
Clinique Beau Soleil
🇫🇷Montpellier, France
Addenbrookes Hospital
🇬🇧Cambridge, United Kingdom
UZ Brussels
🇧🇪Brussels, Belgium
UZ Antwerpen
🇧🇪Edegem, Belgium
Frederiksbergs Hospital
🇩🇰Frederiksberg, Denmark
Odense Universitets hospital
🇩🇰Odense, Denmark
CHU Pasteur
🇫🇷Nice, France
Hospital General Universitario
🇪🇸Madrid, Spain
Instituto de Oncología
🇪🇸Valencia, Spain
University Hospital Coventry
🇬🇧Coventry, United Kingdom
Fredericia Sygehus
🇩🇰Fredericia, Denmark
Herlev University Hospital
🇩🇰Herlev, Denmark
Derby City Hosptial
🇬🇧Derby, United Kingdom
Leicester General Hospital
🇬🇧Leicester, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, United Kingdom
CHU Toulouse
🇫🇷Toulouse, France
Hôpital Henry Gabrielle
🇫🇷Saint Genis Laval, France
Royal Devon and Exeter Hospital
🇬🇧Exeter, United Kingdom
Falkirk & District Royal Infirmary
🇬🇧Falkirk, United Kingdom
Hôpital Erasme
🇧🇪Brussels, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
P.Stradins Clinical University Hospital
🇱🇻Riga, Latvia
Ziekenhuis Amstelland
🇳🇱Amstelveen, Netherlands
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
CHU de Liège
🇧🇪Liège, Belgium
Antonius Ziekenhuis
🇳🇱Sneek, Netherlands
Sc E-Uro Srl
🇷🇴Cluj Napoca, Romania
Medical University Clinics
🇱🇹Kaunas, Lithuania
University Oncological Institute
🇱🇹Vilnius, Lithuania
Medical Center
🇷🇴Arad, Romania
University Hospital
🇱🇹Klaipeda, Lithuania
Oncology Institute
🇷🇴Bucharest, Romania
Oncomed
🇷🇴Timisoara, Romania
Diaconessenhuis
🇳🇱Leiden, Netherlands