A Long-term Observational Study Cohort in Patients With Advanced Prostate Cancer (TRIPTOCARE LT)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01383863
First received: June 27, 2011
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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.


Condition
Advanced Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Castration-resistant prostate cancer (CRPC) [ Time Frame: Over a 3-year period post-androgen deprivation therapy induction ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease progression (DP) rate post-androgen deprivation therapy induction [ Time Frame: Over a 3-year period post-androgen deprivation therapy induction ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 3-years post-androgen deprivation therapy induction ] [ Designated as safety issue: No ]
  • Serum prostate specific antigen [ Time Frame: Over a 3-year period post-androgen deprivation therapy induction ] [ Designated as safety issue: No ]
  • Serum testosterone [ Time Frame: Over a 3-year period post-androgen deprivation therapy induction ] [ Designated as safety issue: No ]

Estimated Enrollment: 187
Study Start Date: October 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01383863

Locations
Denmark
Fredericia Sygehus
Fredericia, Denmark
Frederiksbergs Hospital
Frederiksberg, Denmark
Herlev University Hospital
Herlev, Denmark
Odense Universitets Hospital
Odense, Denmark
France
Clinique Rhône Durance
Avignon, France, 84000
Hôpital Pellegrin
Bordeaux, France, 33076
CHU Henri Mondor
Créteil, France, 94010
Chru Lille
Lille, France, 59037
Hôpital Nord
Marseille, France, 13915
Clinique Beau Soleil
Montpellier, France, 34000
Private practice
Nancy, France, 5410
CHU Nantes
Nantes, France, 44093
CHU Pasteur
Nice, France, 0600
Hôpital Val de Grâce
Paris, France, 75005
Institut Mutualiste Monsouris
Paris, France, 75014
Hôpital Henry Gabrielle
Saint Genis Laval, France, 69230
Hôpital Foch
Suresnes, France, 92150
Latvia
Center of Oncology
Riga, Latvia, LV1079
P.Stradins Clinical University Hospital
Riga, Latvia, LV 1002
Lithuania
Medical University Clinics
Kaunas, Lithuania
University Hospital
Klaipeda, Lithuania
University Oncological Institute
Vilnius, Lithuania
Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Diaconessenhuis
Leiden, Netherlands
Romania
Medical Center
Arad, Romania
Sc E-Uro Srl
Cluj Napoca, Romania
Oncomed
Timisoara, Romania
United Kingdom
Ulster hospital
Belfast, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 8RP
University Hospital Wales
Cardiff, United Kingdom, CF14 4XW
University Hospital Coventry
Coventry, United Kingdom, CV3 / CV2 2DX
Leicester General Hospital
Leicester, United Kingdom, LE5 4PW
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1PB
Lister Hospital
Stevenage, United Kingdom, SG1 4AB
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Patrick Cabri, M.D. Ipsen
  More Information

Additional Information:
No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01383863     History of Changes
Other Study ID Numbers: 8-79-52014-187
Study First Received: June 27, 2011
Last Updated: October 29, 2013
Health Authority: Denmark: Ethics Committee
France: Conseil National de l'Ordre des Médecins
Latvia: State Agency of Medicines
Netherlands: Independent Ethics Committee
Romania: National Medicines Agency
Lithuania: Data Protection Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014