Prostate CancerPhase 3NCT00415246
Study to Evaluate a Subcutaneous Four Months Sustained-release Formulation of Triptorelin in Patients With Prostate Cancer
A Phase 3 study testing Triptorelin (Decapeptyl®) - Treatment 8 months (pivotal study) followed by a treatment extension of 8 months (extension study) in people with Prostate Cancer, run by Ipsen at 31 sites in 8 countries.
Trial summary
To identify the proportion of patients remaining medically castrated (testosterone level < 50 ng/dL) on Day 240 following two administrations of a 4-month sustained-release (SR) formulation of triptorelin. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Triptorelin (Decapeptyl®) - Treatment 8 months (pivotal study) followed by a treatment extension of 8 months (extension study)
- How many people
- 100 participants
- Where
- 31 sitesin 8 countries
- Study dates
- Nov 2006to Oct 2007
- Phase
- Phase 3
- 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
Who may be able to join
- Patient must give written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of the normal medical care of the patient
- Patient must be 18 years old or over
- Patient must have a histologically-confirmed diagnosis of locally advanced or metastatic prostate cancer or presenting a relapse after curative treatment which is amenable to androgen deprivation therapy
- Patient must have an estimated survival time of greater than 8 months according to the investigator's assessment
Who cannot join
- Patient at risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or with significant obstructive uropathy)
- Patient who underwent a previous surgical castration
- Prostate cancer therapy within 2 months of baseline visit
- Patient with testosterone level below 150 ng/dL at screening
Trial locations and contacts
31 sites in 8 countries.
31 sites in 8 countries
France12 sites
CHU Hôpital Gabriel Montpied
Clermont-Ferrand, 63003
Hôpital Claude Huriez
Lille, 59037
Hôpital Edouard Herriot
Lyon, 69437
CHU Hôpital Salvator
Marseille, 13274
Hôtel Dieu
Nantes, 44093
Hôpital du Val de Grace
Paris, 75230
Centre Hospitalier Saint Louis
Paris, 75475
Hôpital Cochin
Paris, 75679
Hôpital Bichat
Paris, 75788
CHU Hôpital de la Miletrie
Poitiers, 86000
Hôpital Pontchaillou
Rennes, 35033
CHU Rangueil
Toulouse, 31059
Belgium5 sites
ULB Erasme
Brussels, B-1070
Academisch Ziekenhuis Vrije Universiteit Brussel
Brussels, B-1090
UCL St Luc
Brussels, B-1200
Universitair Ziekenhuis Antwerpen
Edegem, B-2650
UZ Gasthuisberg
Leuven, B-3000
Poland4 sites
Swietokrzyskie Centrum Onkologii
Kielce
NZOZ Specjalista Sp, z.o.o.
Kutno
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
Warsaw
Akademicki Szpital Kliniczny
Wroclaw
Latvia3 sites
Olega Hublarova arsta prakse urologija
Daugavpils
Latvijas Onkologijas centre
Riga
Paula Stradina Kliniska Universitates slimnica
Riga
Lithuania3 sites
Kauno Medicinos Universitteto Klinikos
Kaunas
UAB 'Vilniaus onkourologijos-ginekologijos klinika
Vilnius
Vilniaus universiteto
Vilnius
Ukraine2 sites
Ivano Frankovsk State Medical University
Ivano-Frankivsk
Scientific Research Institute of Urology
Kiev
About this study
Official title: A Phase III, Single Arm, Multicentre Study to Evaluate the Efficacy and Safety of a Subcutaneous Four Months Sustained-release Formulation of Triptorelin, a Gonadotrophin Releasing Hormone Analogue in Patients With Prostate Cancer
To identify the proportion of patients remaining medically castrated (testosterone level < 50 ng/dL) on Day 240 following two administrations of a 4-month sustained-release (SR) formulation of triptorelin.
- Conditions
- Prostate Cancer
- Being tested
- Triptorelin (Decapeptyl®) - Treatment 8 months (pivotal study) followed by a treatment extension of 8 months (extension study)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triptorelin (Decapeptyl®) - Treatment 8 months (pivotal study) followed by a treatment extension of 8 months (extension study)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL.
Measured: Day 240
Secondary outcomes (6)
Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL.
Measured: Day 120
Proportion of patients with testosterone serum levels maintained below the castration threshold of 20 ng/dL.
Measured: Day 120 and 240
Time to achieve castration in days post treatment (Tlag)
Measured: Day 35
Time to escape from castration (Texit)
Measured: Prior 4 months
Tlag and Texit confirmed by two consecutive measurements taken 1 week apart.
Duration of castration in days (Tcast) Changes in PSA levels.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startNov 2006
- Study completionOct 2007
Why it stopped: The preliminary data do not support the expected sustainable blood levels of triptorelin for a duration of 4 months in all patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
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
- NCT00415246
- Sponsor's protocol ID
- 2-55-52014-145
- Other IDs
- 2006-001511-30
- Status last verified
- Nov 2019
- First submitted
- 21 Dec 2006
- Last updated
- 22 Nov 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Single Arm, Multicentre Study to Evaluate the Efficacy and Safety of a Subcutaneous Four Months Sustained-release Formulation of Triptorelin, a Gonadotrophin Releasing Hormone Analogue in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT00415246
- Acronym / sponsor ID
- 2-55-52014-145
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The preliminary data do not support the expected sustainable blood levels of triptorelin for a duration of 4 months in all patients.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Study completion
- Oct 2007 (actual)
- First posted
- 22 Dec 2006 (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.
To identify the proportion of patients remaining medically castrated (testosterone level < 50 ng/dL) on Day 240 following two administrations of a 4-month sustained-release (SR) formulation of triptorelin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must give written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of the normal medical care of the patient
- Patient must be 18 years old or over
- Patient must have a histologically-confirmed diagnosis of locally advanced or metastatic prostate cancer or presenting a relapse after curative treatment which is amenable to androgen deprivation therapy
- Patient must have an estimated survival time of greater than 8 months according to the investigator's assessment
Key exclusion criteria (4 listed)
- Patient at risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or with significant obstructive uropathy)
- Patient who underwent a previous surgical castration
- Prostate cancer therapy within 2 months of baseline visit
- Patient with testosterone level below 150 ng/dL at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triptorelin (Decapeptyl®) - Treatment 8 months (pivotal study) followed by a treatment extension of 8 months (extension study) | Drug | – |
Primary outcome
Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL.
Time frame: Day 240
6 secondary outcomes
Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL.
Time frame: Day 120
Proportion of patients with testosterone serum levels maintained below the castration threshold of 20 ng/dL.
Time frame: Day 120 and 240
Time to achieve castration in days post treatment (Tlag)
Time frame: Day 35
Time to escape from castration (Texit)
Time frame: Prior 4 months
Tlag and Texit confirmed by two consecutive measurements taken 1 week apart.
Duration of castration in days (Tcast) Changes in PSA levels.
Results and safety
The study was stopped early (reason given: The preliminary data do not support the expected sustainable blood levels of triptorelin for a duration of 4 months in all patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
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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
31 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triptorelin (Decapeptyl®) - Treatment 8 months (pivotal study) followed by a treatment extension of 8 months (extension study) in people with Prostate Cancer, run by Ipsen at 31 sites in 8 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in France, Belgium, Poland, Latvia, Lithuania and 3 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The preliminary data do not support the expected sustainable blood levels of triptorelin for a duration of 4 months in all patients.). Results are not available in the source record.
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?
Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL. (time frame: Day 240). 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 22 Nov 2019; AzTrials last refreshed its copy on 28 Oct 2026.