Prostate CancerOCTNCT00811876
Retrospective, Non-interventional Study of Depo-Eligard®.
An observational study of Prostate Cancer, run by Astellas Pharma Inc at 23 sites in Belgium.
Trial summary
Study will evaluate the real-world effectiveness of Depo-Eligard® after six months of treatment 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?
- Data Collection on Depo-Eligard exposure
- How many people
- 140 participants
- Where
- 23 sitesBelgium
- Study dates
- Sep 2008to Dec 2009
- 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 from Belgian participating investigator sites having been prescribed Depo-Eligard® in accordance with the terms of the marketing authorization, on treatment with Depo-Eligard® for at least six months.
Who may be able to join
- Patients having been prescribed Depo-Eligard® in accordance with the terms of the marketing authorization
- Patients on treatment with Depo-Eligard® for at least six months
- Written consent has been obtained
Who cannot join
None listed.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Belgium23 sites
Study site
Antwerp, 2060
Study site
Berlaar, 2590
Study site
Bornem, 2880
Study site
Brussels, 1020
Study site
Brussels, 1070
Study site
Brussels, 1090
Study site
Charleroi, 6000
Study site
Ghent, 9000
Study site
Jemeppe, 4101
Study site
Kortrijk, 8500
Study site
Leuven, 3000
Study site
Liège, 4000
Study site
Lommel, 3290
Study site
Merksem, 2170
Study site
Mons, 7000
Study site
Mortsel, 2640
Study site
Ragnies, 6532
Study site
Tienen, 3300
Study site
Tongeren, 3700
Study site
Turnhout, 2300
Study site
Waregem, 8790
Study site
Willebroek, 2830
Study site
Yvoir, 5530
About this study
Official title: Monitoring Tolerance, Safety and Acceptance of Depo-Eligard® in an Open Label, Retrospective, Non-interventional Clinical Trial
Study will evaluate the real-world effectiveness of Depo-Eligard® after six months of treatment
Read the detailed description
The study will provide data on the tolerance, safety and acceptance of Depo-Eligard® (leuproreline acetate) when used in routine clinical practice. Data on efficacy parameters such as testosterone, PSA levels, symptoms and treatment failure, if available will be collected.It will reflect the way Depo-Eligard® is used in routine clinical practice and how PSA, testosterone levels, symptoms and treatment failure, are used as parameters in the treatment for Prostate Cancer.
Patient data will be collected after a treatment period of six months.
- Conditions
- Prostate Cancer
- Being tested
- Data Collection on Depo-Eligard exposure
- Keywords
- 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.
Data Collection on Depo-Eligard exposureOther
Also called leuproreline acetate exposure
Retrospective, Non-interventional
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance, Safety (Adverse drug reactions, overall evaluation of safety and tolerability) and Acceptance of Depo-Eligard®
Measured: After at least 6 months treatment with Depo-Eligard
Secondary outcomes (3)
Measurement of PSA and testosterone levels if available
Measured: After at least 6 months treatment with Depo-Eligard
Overall evaluation of efficacy
Measured: After a least 6 months treatment with Depo-Eligard
Overall patient assessment of treatment benefit
Measured: After at least 6 months treatment with Depo-Eligard
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2009
- Study completionDec 2009
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.
- 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
- Retrospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Use Central Contact, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811876
- Sponsor's protocol ID
- BE-08-EGD-02
- Acronym
- OCT
- Status last verified
- Jan 2010
- First submitted
- 17 Dec 2008
- Last updated
- 22 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Tolerance, Safety and Acceptance of Depo-Eligard® in an Open Label, Retrospective, Non-interventional Clinical Trial
- ClinicalTrials.gov ID
- NCT00811876
- Acronym / sponsor ID
- OCT / BE-08-EGD-02
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 19 Dec 2008 (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.
Study will evaluate the real-world effectiveness of Depo-Eligard® after six months of treatment
Detailed description
The study will provide data on the tolerance, safety and acceptance of Depo-Eligard® (leuproreline acetate) when used in routine clinical practice. Data on efficacy parameters such as testosterone, PSA levels, symptoms and treatment failure, if available will be collected.It will reflect the way Depo-Eligard® is used in routine clinical practice and how PSA, testosterone levels, symptoms and treatment failure, are used as parameters in the treatment for Prostate Cancer.
Patient data will be collected after a treatment period of six months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from Belgian participating investigator sites having been prescribed Depo-Eligard® in accordance with the terms of the marketing authorization, on treatment with Depo-Eligard® for at least six months.
Key inclusion criteria (3 listed)
- Patients having been prescribed Depo-Eligard® in accordance with the terms of the marketing authorization
- Patients on treatment with Depo-Eligard® for at least six months
- Written consent has been obtained
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Data Collection on Depo-Eligard exposureAlso: leuproreline acetate exposureRetrospective, Non-interventional | Other | – |
Primary outcome
Tolerance, Safety (Adverse drug reactions, overall evaluation of safety and tolerability) and Acceptance of Depo-Eligard®
Time frame: After at least 6 months treatment with Depo-Eligard
3 secondary outcomes
Measurement of PSA and testosterone levels if available
Time frame: After at least 6 months treatment with Depo-Eligard
Overall evaluation of efficacy
Time frame: After a least 6 months treatment with Depo-Eligard
Overall patient assessment of treatment benefit
Time frame: After at least 6 months treatment with Depo-Eligard
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 22 Jan 2010.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Use Central Contact study director
Astellas Pharma Europe B.V.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Astellas Pharma Inc at 23 sites in Belgium.
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 0 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 22 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Belgium. 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?
Tolerance, Safety (Adverse drug reactions, overall evaluation of safety and tolerability) and Acceptance of Depo-Eligard® (time frame: After at least 6 months treatment with Depo-Eligard). 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 Jan 2010.