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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01383863
Recruitment Status : Completed
First Posted : June 28, 2011
Last Update Posted : July 30, 2014
Information provided by (Responsible Party):

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.

Condition or disease
Advanced Prostate Cancer

Study Type : Observational
Actual Enrollment : 180 participants
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)
Study Start Date : October 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Primary Outcome Measures :
  1. Castration-resistant prostate cancer (CRPC) [ Time Frame: Over a 3-year period post-androgen deprivation therapy induction ]

Secondary Outcome Measures :
  1. Disease progression (DP) rate post-androgen deprivation therapy induction [ Time Frame: Over a 3-year period post-androgen deprivation therapy induction ]
  2. Overall survival [ Time Frame: 3-years post-androgen deprivation therapy induction ]
  3. Serum prostate specific antigen [ Time Frame: Over a 3-year period post-androgen deprivation therapy induction ]
  4. Serum testosterone [ Time Frame: Over a 3-year period post-androgen deprivation therapy induction ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01383863

Fredericia Sygehus
Fredericia, Denmark
Frederiksbergs Hospital
Frederiksberg, Denmark
Herlev University Hospital
Herlev, Denmark
Odense Universitets Hospital
Odense, Denmark
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
P.Stradins Clinical University Hospital
Riga, Latvia, LV 1002
Center of Oncology
Riga, Latvia, LV1079
Medical University Clinics
Kaunas, Lithuania
University Hospital
Klaipeda, Lithuania
University Oncological Institute
Vilnius, Lithuania
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Leiden, Netherlands
Medical Center
Arad, Romania
Sc E-Uro Srl
Cluj Napoca, Romania
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
Study Director: Patrick Cabri, M.D. Ipsen

Additional Information:
Responsible Party: Ipsen Identifier: NCT01383863     History of Changes
Other Study ID Numbers: 8-79-52014-187
First Posted: June 28, 2011    Key Record Dates
Last Update Posted: July 30, 2014
Last Verified: July 2014

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