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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