Advanced Prostate CarcinomaNCT02128334
An Observational Study Looking at How Well the Drug Eligard Works and How Well it is Tolerated by the Body of Patients With Advanced Prostate Carcinoma in the Russian Federation
An observational study of Advanced Prostate Carcinoma, run by Astellas Pharma Europe B.V. at 52 sites in Russia.
Trial summary
Eligard is a 6-month depot injection formulation that combines the active ingredient leuprorelin acetate (LA) with a biodegradable polymer matrix (Atrigel® delivery system). The 6-month (45 mg) formulation was approved for the Russian market in 2009. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Advanced Prostate Carcinoma
- What is being tested?
- Eligard 45 mg Exposure
- Type of treatment
- Injection or infusion
- How many people
- 645 participants
- Where
- 52 sitesRussia
- Study dates
- Sep 2013to Mar 2016
- 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: Male patients >18 years of age with advanced prostate cancer (PCa) to whom Eligard 45 mg was prescribed
Who may be able to join
- All male patients > 18 years of age with advanced PCa to whom oncourologist decided to prescribe Eligard 45 mg
Who cannot join
- Patient participation in any clinical trials.
Trial locations and contacts
52 sites in 1 country.
52 sites in 1 country
Russia52 sites
Site RU34 Private Practice
Abakan
Site RU23 Private Practice
Anapa
Site RU33 Private Practice
Belgorod
Site RU27 Private Practice
Irkutsk
Site RU29 Private Practice
Irkutsk
Site RU36 Private Practice
Izhevsk
Site RU60 Private Practice
Kostroma
Site RU10 Private Practice
Krasnodar
Site RU12 Private Practice
Krasnodar
Site RU13 Private Practice
Krasnodar
Site RU9 Private Practice
Krasnodar
Site RU35 Private Practice
Kursk
Site RU1 Private Practice
Moscow
Site RU11 Private Practice
Moscow
Site RU14 Private Practice
Moscow
Site RU15 Private Practice
Moscow
Site RU2 Private Practice
Moscow
Site RU20 Private Practice
Moscow
Site RU3 Private Practice
Moscow
Site RU32 Private Practice
Moscow
Site RU4 Private Practice
Moscow
Site RU42 Private Practice
Moscow
Site RU44 Private Practice
Moscow
Site RU55 Private Practice
Moscow
Site RU56 Private Practice
Moscow
Site RU6 Private Practice
Moscow
Site RU61 Private Practice
Moscow
Site RU7 Private Practice
Moscow
Site RU71 Private Practice
Moscow
Site RU72 Private Practice
Moscow
Site RU8 Private Practice
Moscow
Site RU21 Private Practice
Nizhny Novgorod
Site RU63 Private Practice
Nizhny Novgorod
Site RU64 Private Practice
Nizhny Novgorod
Site RU53 Private Practice
Novosibirsk
Site RU30 Private Practice
Omsk
Site RU18 Private Practice
Orenburg
Site RU66 Private Practice
Orenburg
Site RU68 Private Practice
Oryol
Site RU37 Private Practice
Petrozavodsk
Site RU40 Private Practice
Ryazan
Site RU73 Private Practice
Ryazan
Site RU17 Private Practice
Saint Petersburg
Site RU19 Private Practice
Saint Petersburg
Site RU65 Private Practice
Saint Petersburg
Site RU76 Private Practice
Saint Petersburg
Site RU59 Private Practice
Stavropol
Site RU25 Private Practice
Syktyvkar
Site RU54 Private Practice
Tver'
Site RU26 Private Practice
Yekaterinburg
Site RU43 Private Practice
Yekaterinburg
Site RU58 Private Practice
Yekaterinburg
About this study
Official title: Prospective Multicenter Observational Program for Evaluation of Efficacy and Tolerability of the 6-month Depot Eligard 45 mg in Patients With Advanced Prostate Carcinoma in Routine Clinical Practice of Uro-Oncologists in the Russian Federation
Eligard is a 6-month depot injection formulation that combines the active ingredient leuprorelin acetate (LA) with a biodegradable polymer matrix (Atrigel® delivery system). The 6-month (45 mg) formulation was approved for the Russian market in 2009. It has been shown to reduce testosterone and prostate-specific antigen (PSA) levels and to be well tolerated in several clinical trials. However, clinical trials are limited by strict patient inclusion and exclusion criteria. Therefore, the current non-interventional study aimed at investigating whether the efficacy and tolerability of the 6-month LA depot formulation could also be confirmed in a broad and heterogeneous patient population encountered in daily clinical practice in the Russian Federation.
This study will evaluate total serum PSA and testosterone levels, Quality of Life (QoL) of patients, demographic patient data, diagnosis and diagnostic findings in patients. It will provide analysis in different subgroups of patients depending on previous hormonal treatment and anamnesis of disease.
- Conditions
- Advanced Prostate Carcinoma
- Being tested
- Eligard 45 mg Exposure
- Keywords
- Uro-Oncologists, PSA, Eligard, prostate carcinoma
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eligard 45 mg ExposureDrug
Also called leuprorelin acetate
Subcutaneous injections
| Study group | Role | What they receive |
|---|---|---|
| Patients with advanced prostate carcinoma | Not described Receives: Drug: Eligard 45 mg Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in total serum PSA
Measured: Baseline and every 6 months until 24 months after treatment start
Percentage change in testosterone levels
Measured: Baseline and every 6 months until 24 months after treatment start
Secondary outcomes (2)
Number of adverse drug reactions
Measured: Baseline to 24 months after treatment start
Mean change in QoL based on EuroQOL five dimensions questionnaire (EQ-5D)
Measured: Baseline to 24 months after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startSep 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Prostate CarcinomaStudies of the same condition, open and under way.
- 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
- 645 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Principal investigator, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128334
- Sponsor's protocol ID
- RU-EGD-NI-001
- Status last verified
- Aug 2016
- First submitted
- 29 Apr 2014
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Observational Program for Evaluation of Efficacy and Tolerability of the 6-month Depot Eligard 45 mg in Patients With Advanced Prostate Carcinoma in Routine Clinical Practice of Uro-Oncologists in the Russian Federation
- ClinicalTrials.gov ID
- NCT02128334
- Acronym / sponsor ID
- RU-EGD-NI-001
- Conditions
- Advanced Prostate Carcinoma
- Keywords
- Uro-Oncologists, PSA, Eligard, prostate carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 645 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 May 2014 (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.
Eligard is a 6-month depot injection formulation that combines the active ingredient leuprorelin acetate (LA) with a biodegradable polymer matrix (Atrigel® delivery system). The 6-month (45 mg) formulation was approved for the Russian market in 2009. It has been shown to reduce testosterone and prostate-specific antigen (PSA) levels and to be well tolerated in several clinical trials. However, clinical trials are limited by strict patient inclusion and exclusion criteria. Therefore, the current non-interventional study aimed at investigating whether the efficacy and tolerability of the 6-month LA depot formulation could also be confirmed in a broad and heterogeneous patient population encountered in daily clinical practice in the Russian Federation.
This study will evaluate total serum PSA and testosterone levels, Quality of Life (QoL) of patients, demographic patient data, diagnosis and diagnostic findings in patients. It will provide analysis in different subgroups of patients depending on previous hormonal treatment and anamnesis of disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with advanced prostate carcinoma | – | Drug: Eligard 45 mg Exposure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients >18 years of age with advanced prostate cancer (PCa) to whom Eligard 45 mg was prescribed
Key inclusion criteria (1 listed)
- All male patients > 18 years of age with advanced PCa to whom oncourologist decided to prescribe Eligard 45 mg
Key exclusion criteria (1 listed)
- Patient participation in any clinical trials.
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 |
|---|---|---|
| Eligard 45 mg ExposureAlso: leuprorelin acetateSubcutaneous injections | Drug | Patients with advanced prostate carcinoma |
Primary outcome
Percentage change in total serum PSA
Time frame: Baseline and every 6 months until 24 months after treatment start
Percentage change in testosterone levels
Time frame: Baseline and every 6 months until 24 months after treatment start
2 secondary outcomes
Number of adverse drug reactions
Time frame: Baseline to 24 months after treatment start
Mean change in QoL based on EuroQOL five dimensions questionnaire (EQ-5D)
Time frame: Baseline to 24 months after treatment start
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 16 Aug 2016.
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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.
Central Contact principal investigator
Astellas Pharma Europe B.V.
52 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Prostate Carcinoma, run by Astellas Pharma Europe B.V. at 52 sites in Russia.
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 1 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 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in Russia. 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?
Percentage change in total serum PSA (time frame: Baseline and every 6 months until 24 months after treatment start). The study lists 2 primary outcomes in all. 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 16 Aug 2016.