Advanced Prostate Cancer Clinical Trial
— TRIPTOCARE LTOfficial title:
A Prospective Observational Study Cohort to Assess the Rate of Castration Resistance, Disease Progression and Overall Survival Over a 3-year Period Post-androgen Deprivation Therapy Induction in Patients With Advanced Prostate Cancer Who Have Previously Participated in the Triptocare Study (Http://Clinicaltrials.Gov/ct2/Show/Study/NCT01020448)
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 |
Verified date | January 2019 |
Source | Ipsen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Ipsen |
Denmark, France, Latvia, Lithuania, Netherlands, Romania, United Kingdom,
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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