Prostate CancerPhase 3TriptocareNCT01020448
Effect of Triptorelin (Decapeptyl®) 22.5 mg on Two Biomarkers in Patients With Advanced Prostate Cancer
A Phase 3 study testing Triptorelin (Decapeptyl®) in people with Prostate Cancer, run by Ipsen at 59 sites in 10 countries.
Trial summary
The purpose of this study is to evaluate the effect of an initial hormonal treatment gonadotrophin-releasing hormone (GnRH Agonist) on 2 biomarkers (PCA3 and TMPRSS2-ERG), in patients with histologically confirmed and advanced stages of prostate cancer. 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®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 59 sitesin 10 countries
- Study dates
- Nov 2009to Jun 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- A histologically confirmed, locally advanced or metastatic prostate cancer, and naïve to androgen deprivation therapy, and a candidate for hormonal treatment.
- An estimated survival time of at least twelve months according to the investigator's assessment.
- A performance status score ≤ 2 according to the World Health Organisation (WHO) criteria.
Who cannot join
- Previous surgical castration.
- Previous or has planned curative prostate cancer therapy (radiation/surgery)
- Previous hormone therapy (GnRH analogues, estrogens or anti-androgens)
- Patients with risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or significant obstructive uropathy)
Trial locations and contacts
59 sites in 10 countries.
59 sites in 10 countries
France15 sites
Clinique Rhône Durance
Avignon, 84000
Hôpital Pellegrin
Bordeaux, 33076
CHU Henri Mondor
Créteil, 94010
CHU Michalon
Grenoble, 38043
Chru Lille
Lille, 59037
Hôpital Nord
Marseille, 13915
Clinique Beau Soleil
Montpellier, 34000
Private practice
Nancy, 54100
CHU Nantes
Nantes, 44093
CHU Pasteur
Nice, 06002
Hôpital Val de Grâce
Paris, 75005
Institut Mutualiste Monsouris
Paris, 75014
Hôpital Henry Gabrielle
Saint-Genis-Laval, 69230
Hôpital Foch
Suresnes, 92150
CHU Toulouse
Toulouse, 31059
United Kingdom11 sites
Bristol Royal Infirmary
Bristol
Addenbrookes Hospital
Cambridge, CB2 8RP
University Hospital Wales
Cardiff, CF14 4XW
University Hospital Coventry
Coventry, CV3 / CV2 2DX
Derby City Hosptial
Derby, DE22 3NE
Royal Devon and Exeter Hospital
Exeter, EX2 5DW
Falkirk & District Royal Infirmary
Falkirk, FK1 5QE
Leicester General Hospital
Leicester, LE5 4PW
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Nottingham City Hospital
Nottingham, NG5 1PB
Lister Hospital
Stevenage, SG1 4AB
Spain8 sites
Hospital Juan Canalejo
A Coruña, 15006
Hospital Valle Hebrón
Barcelona, 08035
Hospital Clinic
Barcelona, 08036
Hospital de Basurto
Bilbao, 48013
Hospital General Universitario
Madrid, 28007
Hospital 12 de Octubre
Madrid, 28041
Hospital Infanta Sofía
Madrid, 28702
Instituto de Oncología
Valencia, 46009
Belgium6 sites
Hôpital Erasme
Brussels, 1070
UZ Brussels
Brussels, 1090
UCL Saint-Luc
Brussels, 1200
UZ Antwerpen
Edegem, 2650
UZ Leuven
Leuven, 3000
CHU de Liège
Liège, 4000
Denmark4 sites
Fredericia Sygehus
Fredericia
Frederiksbergs Hospital
Frederiksberg, 2000
Herlev University Hospital
Herlev, 2730
Odense Universitets hospital
Odense, 5000
Netherlands4 sites
Ziekenhuis Amstelland
Amstelveen
Academisch Medisch Centrum
Amsterdam, 1105 AZ
Diaconessenhuis
Leiden, 2333ZA
Antonius Ziekenhuis
Sneek
Romania4 sites
Medical Center
Arad
Oncology Institute
Bucharest, 72435
Sc E-Uro Srl
Cluj-Napoca
Oncomed
Timișoara
Lithuania3 sites
Medical University Clinics
Kaunas, LT-50009
University Hospital
Klaipėda
University Oncological Institute
Vilnius, LT-08660
Italy2 sites
IRCCS Fondazione S. Raffaele del Monte Tabor
Milan, 20132
AOU San Luigi Gonzaga
Torino, 10043
Latvia2 sites
P.Stradins Clinical University Hospital
Riga, LV 1002
Center of Oncology
Riga, LV1079
About this study
Official title: Prostate Cancer Antigen-3 (PCA-3) and TMPRSS2-ERG (T2-ERG) Score Changes During Initiation of Androgen Deprivation Therapy (ADT) With Triptorelin 22.5mg in Patients With Advanced Prostate Cancer (PCA): A Phase III, Single Arm Multicentre Study
The purpose of this study is to evaluate the effect of an initial hormonal treatment gonadotrophin-releasing hormone (GnRH Agonist) on 2 biomarkers (PCA3 and TMPRSS2-ERG), in patients with histologically confirmed and advanced stages of prostate cancer. Their characteristics, according to risk factors such as PSA and Gleason score will be determined at baseline and 1, 3 and 6 month post-treatment.
- Conditions
- Prostate Cancer
- Being tested
- Triptorelin (Decapeptyl®)
- Keywords
- Locally advanced or metastatic Prostate Cancer
- 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®)Drug
One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
| Study group | Role | What they receive |
|---|---|---|
| Triptorelin (Decapeptyl®) 22.5 mg | Experimental | Not described Receives: Drug: Triptorelin (Decapeptyl®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA
PCA-3 score = (mRNA PCA3/mRNA PSA)x1000
- Non-assessable = Associated PSA mRNA <7500 copies/mL
- ≤BLQ = PCA-3 mRNA is below the concentration of the calibrator and associated PSA mRNA >7500 copies/mL
- <35 = PCA-3 mRNA above BLQ and less than 35
- ≥35 = PCA-3 mRNA greater or equal to 35
Measured: At month 6 post-treatment
Secondary outcomes (5)
PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA
PCA-3 score = (mRNA PCA3/mRNA PSA)x1000
- Non-assessable = Associated PSA mRNA <7500 copies/mL
- ≤BLQ = PCA-3 mRNA is below the concentration of the calibrator and associated PSA mRNA >7500 copies/mL
- <35 = PCA-3 mRNA above BLQ and less than 35
- ≥35 = PCA-3 mRNA greater or equal to 35
Measured: At month 1 and 3 post-treatment
TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)
TMPRSS2-ERG = (TMPRSS2-ERG mRNA / PSA mRNA) x 100000
A TMPRSS2-ERG score <35 was described as 'negative' and a TMPRSS2-ERG score ≥35 as 'positive.'
Measured: At baseline, month 1, 3 and 6 post-treatment
Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL)
Measured: At month 1, 3 and 6 post-treatment
PSA Level
Measured: At baseline, month 1, 3 and 6 post-treatment
Safety, Assessed Through the Collection of Adverse Events (AEs)
Measured: For the duration of the study (up to month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2011
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 339 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
- NCT01020448
- Sponsor's protocol ID
- 8-79-52014-168
- Other IDs
- 2009-012786-58, 2009
- Acronym
- Triptocare
- Status last verified
- Jan 2019
- First submitted
- 24 Nov 2009
- Last updated
- 30 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer Antigen-3 (PCA-3) and TMPRSS2-ERG (T2-ERG) Score Changes During Initiation of Androgen Deprivation Therapy (ADT) With Triptorelin 22.5mg in Patients With Advanced Prostate Cancer (PCA): A Phase III, Single Arm Multicentre Study
- ClinicalTrials.gov ID
- NCT01020448
- Acronym / sponsor ID
- Triptocare / 8-79-52014-168
- Conditions
- Prostate Cancer
- Keywords
- Locally advanced or metastatic Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Posted 15 Jul 2015
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 this study is to evaluate the effect of an initial hormonal treatment gonadotrophin-releasing hormone (GnRH Agonist) on 2 biomarkers (PCA3 and TMPRSS2-ERG), in patients with histologically confirmed and advanced stages of prostate cancer. Their characteristics, according to risk factors such as PSA and Gleason score will be determined at baseline and 1, 3 and 6 month post-treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triptorelin (Decapeptyl®) 22.5 mg | Experimental | Drug: Triptorelin (Decapeptyl®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A histologically confirmed, locally advanced or metastatic prostate cancer, and naïve to androgen deprivation therapy, and a candidate for hormonal treatment.
- An estimated survival time of at least twelve months according to the investigator's assessment.
- A performance status score ≤ 2 according to the World Health Organisation (WHO) criteria.
Key exclusion criteria (4 listed)
- Previous surgical castration.
- Previous or has planned curative prostate cancer therapy (radiation/surgery)
- Previous hormone therapy (GnRH analogues, estrogens or anti-androgens)
- Patients with risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or significant obstructive uropathy)
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®)One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed. | Drug | Triptorelin (Decapeptyl®) 22.5 mg |
Primary outcome
PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA
Time frame: At month 6 post-treatment
PCA-3 score = (mRNA PCA3/mRNA PSA)x1000 * Non-assessable = Associated PSA mRNA <7500 copies/mL * ≤BLQ = PCA-3 mRNA is below the concentration of the calibrator and associated PSA mRNA >7500 copies/mL * <35 = PCA-3 mRNA above BLQ and less than 35 * ≥35 = PCA-3 mRNA greater or equal to 35
5 secondary outcomes
PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA
Time frame: At month 1 and 3 post-treatment
TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)
Time frame: At baseline, month 1, 3 and 6 post-treatment
Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL)
Time frame: At month 1, 3 and 6 post-treatment
PSA Level
Time frame: At baseline, month 1, 3 and 6 post-treatment
Safety, Assessed Through the Collection of Adverse Events (AEs)
Time frame: For the duration of the study (up to month 6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
59 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triptorelin (Decapeptyl®) in people with Prostate Cancer, run by Ipsen at 59 sites in 10 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 3 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: finished, as of the sponsor's last update on 30 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 59 sites in France, United Kingdom, Spain, Belgium, Denmark and 5 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?
Yes. Results are posted in the registry (first posted 15 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA (time frame: At month 6 post-treatment). 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 30 Jan 2019.