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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01383863
Other study ID # 8-79-52014-187
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2011
Est. completion date May 2014

Study information

Verified date January 2019
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Fredericia Sygehus Fredericia
Denmark Frederiksbergs Hospital Frederiksberg
Denmark Herlev University Hospital Herlev
Denmark Odense Universitets Hospital Odense
France Clinique Rhône Durance Avignon
France Hôpital Pellegrin Bordeaux
France CHU Henri Mondor Créteil
France Chru Lille Lille
France Hôpital Nord Marseille
France Clinique Beau Soleil Montpellier
France Private practice Nancy
France CHU Nantes Nantes
France CHU Pasteur Nice
France Hôpital Val de Grâce Paris
France Institut Mutualiste Monsouris Paris
France Hôpital Henry Gabrielle Saint Genis Laval
France Hôpital Foch Suresnes
Latvia Center of Oncology Riga
Latvia P.Stradins Clinical University Hospital Riga
Lithuania Medical University Clinics Kaunas
Lithuania University Hospital Klaipeda
Lithuania University Oncological Institute Vilnius
Netherlands Academisch Medisch Centrum Amsterdam
Netherlands Diaconessenhuis Leiden
Romania Medical Center Arad
Romania Sc E-Uro Srl Cluj Napoca
Romania Oncomed Timisoara
United Kingdom Ulster hospital Belfast
United Kingdom Bristol Royal Infirmary Bristol
United Kingdom Addenbrookes Hospital Cambridge
United Kingdom University Hospital Wales Cardiff
United Kingdom University Hospital Coventry Coventry
United Kingdom Leicester General Hospital Leicester
United Kingdom Nottingham City Hospital Nottingham
United Kingdom Lister Hospital Stevenage

Sponsors (1)

Lead Sponsor Collaborator
Ipsen

Countries where clinical trial is conducted

Denmark,  France,  Latvia,  Lithuania,  Netherlands,  Romania,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Castration-resistant prostate cancer (CRPC) Over a 3-year period post-androgen deprivation therapy induction
Secondary Disease progression (DP) rate post-androgen deprivation therapy induction Over a 3-year period post-androgen deprivation therapy induction
Secondary Overall survival 3-years post-androgen deprivation therapy induction
Secondary Serum prostate specific antigen Over a 3-year period post-androgen deprivation therapy induction
Secondary Serum testosterone Over a 3-year period post-androgen deprivation therapy induction
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