A Long-term Observational Study Cohort in Patients With Advanced Prostate Cancer

Completed

• Conditions: Advanced Prostate Cancer

• Registration Number: NCT01383863
• Lead Sponsor: Ipsen

Brief Summary

The purpose of the protocol is to assess the rate of castration resistance, disease progression and overall survival over a 3-year period post-androgen deprivation therapy (ADT) induction in a study cohort of patients with advanced disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Study Start: 2011-10
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 180

Inclusion Criteria

• Have participated and received study treatment in the Triptocare study
• Be aware of the investigational nature of this observational study cohort and must give written (personally signed and dated) informed consent

Exclusion Criteria

• Absence of written informed consent from the patient

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Castration-resistant prostate cancer (CRPC)	Over a 3-year period post-androgen deprivation therapy induction

Secondary Outcome Measures

Name	Time	Method
Overall survival	3-years post-androgen deprivation therapy induction
Serum prostate specific antigen	Over a 3-year period post-androgen deprivation therapy induction
Serum testosterone	Over a 3-year period post-androgen deprivation therapy induction
Disease progression (DP) rate post-androgen deprivation therapy induction	Over a 3-year period post-androgen deprivation therapy induction

Trial Locations

Locations (35)

Medical University Clinics; 🇱🇹 Kaunas, Lithuania

Sc E-Uro Srl; 🇷🇴 Cluj Napoca, Romania

Nottingham City Hospital; 🇬🇧 Nottingham, United Kingdom

University Oncological Institute; 🇱🇹 Vilnius, Lithuania

Lister Hospital; 🇬🇧 Stevenage, United Kingdom

Bristol Royal Infirmary; 🇬🇧 Bristol, United Kingdom

Ulster hospital; 🇬🇧 Belfast, United Kingdom

Oncomed; 🇷🇴 Timisoara, Romania

Addenbrookes Hospital; 🇬🇧 Cambridge, United Kingdom

Hôpital Pellegrin; 🇫🇷 Bordeaux, France

Clinique Rhône Durance; 🇫🇷 Avignon, France

Hôpital Foch; 🇫🇷 Suresnes, France

Hôpital Nord; 🇫🇷 Marseille, France

CHU Henri Mondor; 🇫🇷 Créteil, France

CHU Nantes; 🇫🇷 Nantes, France

Private practice; 🇫🇷 Nancy, France

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Diaconessenhuis; 🇳🇱 Leiden, Netherlands

Chru Lille; 🇫🇷 Lille, France

Clinique Beau Soleil; 🇫🇷 Montpellier, France

P.Stradins Clinical University Hospital; 🇱🇻 Riga, Latvia

Fredericia Sygehus; 🇩🇰 Fredericia, Denmark

Frederiksbergs Hospital; 🇩🇰 Frederiksberg, Denmark

Herlev University Hospital; 🇩🇰 Herlev, Denmark

Odense Universitets Hospital; 🇩🇰 Odense, Denmark

University Hospital; 🇱🇹 Klaipeda, Lithuania

Center of Oncology; 🇱🇻 Riga, Latvia

Medical Center; 🇷🇴 Arad, Romania

University Hospital Wales; 🇬🇧 Cardiff, United Kingdom

University Hospital Coventry; 🇬🇧 Coventry, United Kingdom

Leicester General Hospital; 🇬🇧 Leicester, United Kingdom

CHU Pasteur; 🇫🇷 Nice, France

Hôpital Val de Grâce; 🇫🇷 Paris, France

Institut Mutualiste Monsouris; 🇫🇷 Paris, France

Hôpital Henry Gabrielle; 🇫🇷 Saint Genis Laval, France