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CompletedNCT01383863TRIPTOCARE LTUpdated Jan 14, 2019

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

An observational study in Advanced Prostate Cancer, sponsored by Ipsen. Completed at 35 sites in 7 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-14.

Sponsored by Ipsen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
180
Ages
18 Years and older
Sex
Male
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Study 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.

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Conditions studied

  • Advanced Prostate Cancer

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.

This study's enrollment of 180 is close to the median of 200 across 1,179 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Absence of written informed consent from the patient
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
180 participants (actual)
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What researchers measure

Primary outcomes

  1. Castration-resistant prostate cancer (CRPC)

    Time frame: Over a 3-year period post-androgen deprivation therapy induction

Secondary outcomes

  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

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Study locations

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

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01383863
Lead sponsor
Ipsen
Responsible party
Sponsor
First posted
Jun 28, 2011
Start date
Oct 2011
Primary completion
May 2014
Completion
May 2014
Last update
Jan 14, 2019

Study contacts

Ipsen Medical Director
study director · Ipsen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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