Advanced Prostate CancerTRIPTOCARE LTNCT01383863
A Long-term Observational Study Cohort in Patients With Advanced Prostate Cancer
An observational study of Advanced Prostate Cancer, run by Ipsen at 35 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Advanced Prostate Cancer
- How many people
- 180 participants
- Where
- 35 sitesin 7 countries
- Study dates
- Oct 2011to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Absence of written informed consent from the patient
Trial locations and contacts
35 sites in 7 countries.
35 sites in 7 countries
France13 sites
Clinique Rhône Durance
Avignon, 84000
Hôpital Pellegrin
Bordeaux, 33076
CHU Henri Mondor
Créteil, 94010
Chru Lille
Lille, 59037
Hôpital Nord
Marseille, 13915
Clinique Beau Soleil
Montpellier, 34000
Private practice
Nancy, 5410
CHU Nantes
Nantes, 44093
CHU Pasteur
Nice, 0600
Hôpital Val de Grâce
Paris, 75005
Institut Mutualiste Monsouris
Paris, 75014
Hôpital Henry Gabrielle
Saint-Genis-Laval, 69230
Hôpital Foch
Suresnes, 92150
United Kingdom8 sites
Ulster hospital
Belfast
Bristol Royal Infirmary
Bristol
Addenbrookes Hospital
Cambridge, CB2 8RP
University Hospital Wales
Cardiff, CF14 4XW
University Hospital Coventry
Coventry, CV3 / CV2 2DX
Leicester General Hospital
Leicester, LE5 4PW
Nottingham City Hospital
Nottingham, NG5 1PB
Lister Hospital
Stevenage, SG1 4AB
Denmark4 sites
Fredericia Sygehus
Fredericia
Frederiksbergs Hospital
Frederiksberg
Herlev University Hospital
Herlev
Odense Universitets Hospital
Odense
Lithuania3 sites
Medical University Clinics
Kaunas
University Hospital
Klaipėda
University Oncological Institute
Vilnius
Latvia2 sites
P.Stradins Clinical University Hospital
Riga, LV 1002
Center of Oncology
Riga, LV1079
Netherlands2 sites
Academisch Medisch Centrum
Amsterdam, 1105 AZ
Diaconessenhuis
Leiden
About this study
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)
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.
- Conditions
- Advanced Prostate Cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Castration-resistant prostate cancer (CRPC)
Measured: Over a 3-year period post-androgen deprivation therapy induction
Secondary outcomes (4)
Disease progression (DP) rate post-androgen deprivation therapy induction
Measured: Over a 3-year period post-androgen deprivation therapy induction
Overall survival
Measured: 3-years post-androgen deprivation therapy induction
Serum prostate specific antigen
Measured: Over a 3-year period post-androgen deprivation therapy induction
Serum testosterone
Measured: Over a 3-year period post-androgen deprivation therapy induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Prostate CancerStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383863
- Sponsor's protocol ID
- 8-79-52014-187
- Acronym
- TRIPTOCARE LT
- Status last verified
- Jan 2019
- First submitted
- 27 Jun 2011
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01383863
- Acronym / sponsor ID
- TRIPTOCARE LT / 8-79-52014-187
- Conditions
- Advanced Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 28 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Absence of written informed consent from the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Castration-resistant prostate cancer (CRPC)
Time frame: Over a 3-year period post-androgen deprivation therapy induction
4 secondary outcomes
Disease progression (DP) rate post-androgen deprivation therapy induction
Time frame: Over a 3-year period post-androgen deprivation therapy induction
Overall survival
Time frame: 3-years post-androgen deprivation therapy induction
Serum prostate specific antigen
Time frame: Over a 3-year period post-androgen deprivation therapy induction
Serum testosterone
Time frame: Over a 3-year period post-androgen deprivation therapy induction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Triptocare study NCT01020448Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
35 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Prostate Cancer, run by Ipsen at 35 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in France, United Kingdom, Denmark, Lithuania, Romania and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Castration-resistant prostate cancer (CRPC) (time frame: Over a 3-year period post-androgen deprivation therapy induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019.