Clinical trial NCT01383863: A Long-term Observational Study Cohort in Patients With Advanced Prostate Cancer
Official 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Prostate Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2011-06-28
Enrollment: 180
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with previously diagnosed advanced prostate cancer, and who have participated in the Triptocare study and who have given written informed consent to participate in the study. They have therefore been treated with triptorelin (22.5 mg, intamuscular) as an ADT induction.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Castration-resistant prostate cancer (CRPC)
timeFrame: Over a 3-year period post-androgen deprivation therapy induction
Secondary outcomes:
measure: Disease progression (DP) rate post-androgen deprivation therapy induction
timeFrame: Over a 3-year period post-androgen deprivation therapy induction
measure: Overall survival
timeFrame: 3-years post-androgen deprivation therapy induction
measure: Serum prostate specific antigen
timeFrame: Over a 3-year period post-androgen deprivation therapy induction
measure: Serum testosterone
timeFrame: Over a 3-year period post-androgen deprivation therapy induction
Other outcomes:
Locations:
city: Fredericia
country: Denmark
facility: Fredericia Sygehus
city: Frederiksberg
country: Denmark
facility: Frederiksbergs Hospital
city: Herlev
country: Denmark
facility: Herlev University Hospital
city: Odense
country: Denmark
facility: Odense Universitets Hospital
city: Avignon
country: France
facility: Clinique Rhône Durance
city: Bordeaux
country: France
facility: Hôpital Pellegrin
city: Créteil
country: France
facility: CHU Henri Mondor
city: Lille
country: France
facility: Chru Lille
city: Marseille
country: France
facility: Hôpital Nord
city: Montpellier
country: France
facility: Clinique Beau Soleil
city: Nancy
country: France
facility: Private practice
city: Nantes
country: France
facility: CHU Nantes
city: Nice
country: France
facility: CHU Pasteur
city: Paris
country: France
facility: Hôpital Val de Grâce
city: Paris
country: France
facility: Institut Mutualiste Monsouris
city: Saint Genis Laval
country: France
facility: Hôpital Henry Gabrielle
city: Suresnes
country: France
facility: Hôpital Foch
city: Riga
country: Latvia
facility: P.Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Center of Oncology
city: Kaunas
country: Lithuania
facility: Medical University Clinics
city: Klaipeda
country: Lithuania
facility: University Hospital
city: Vilnius
country: Lithuania
facility: University Oncological Institute
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Leiden
country: Netherlands
facility: Diaconessenhuis
city: Arad
country: Romania
facility: Medical Center
city: Cluj Napoca
country: Romania
facility: Sc E-Uro Srl
city: Timisoara
country: Romania
facility: Oncomed
city: Belfast
country: United Kingdom
facility: Ulster hospital
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital Wales
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Stevenage
country: United Kingdom
facility: Lister Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: