A Long-term Observational Study Cohort in Patients With Advanced Prostate Cancer

Completed

• Conditions: Advanced Prostate Cancer

• Registration Number: NCT01383863
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Study Start: 2011-10
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Castration-resistant prostate cancer (CRPC)	Over a 3-year period post-androgen deprivation therapy induction

Secondary Outcome Measures

Name	Time	Method
Overall survival	3-years post-androgen deprivation therapy induction
Serum prostate specific antigen	Over a 3-year period post-androgen deprivation therapy induction
Serum testosterone	Over a 3-year period post-androgen deprivation therapy induction
Disease progression (DP) rate post-androgen deprivation therapy induction	Over a 3-year period post-androgen deprivation therapy induction

Trial Locations

Locations (35)

Fredericia Sygehus; 🇩🇰 Fredericia, Denmark

Frederiksbergs Hospital; 🇩🇰 Frederiksberg, Denmark

Herlev University Hospital; 🇩🇰 Herlev, Denmark

Odense Universitets Hospital; 🇩🇰 Odense, Denmark

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

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