Prostate CancerNCT01560858
Treatment Patterns Among Patients With Prostate Cancer Prior to Diagnosis of a Castration-resistant State
An observational study of Prostate Cancer, run by Ipsen at 1 site in Spain.
Trial summary
The purpose of the protocol is to describe treatment patterns among patients with prostate cancer prior to diagnosis of castration-resistant state. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 407 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2012to May 2013
- 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: Community sample
Who may be able to join
- Age ≥ 18 years
- Patients with prostate cancer who had developed a castration resistant state in the last 24 months prior to starting the study
- Patient must give written informed consent before any study related procedure
Who cannot join
- Patients with medical histories lacking data required to evaluate the study objectives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Observational Study to Describe Treatment Patterns Among Patients With Prostate Cancer Prior to Diagnosis of a Castration-resistant State, in Routine Clinical Practice in Spain.
The purpose of the protocol is to describe treatment patterns among patients with prostate cancer prior to diagnosis of castration-resistant state.
- Conditions
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Prior treatment before progression to advanced or metastatic disease.
Number of participants with each category of treatment.
Measured: Baseline
Treatment of advanced or metastatic disease.
Number of participants with each category of treatment.
Measured: Baseline
Secondary outcomes (4)
Clinical management of Castration-Resistant Prostate Cancer (CRPC) patients in the clinical practice.
Percentage of specialists (urologist, radiotherapist, oncologist or other specialist) in charge of treatment decision in CRPC patients.
Measured: Baseline
Number of CRPC patients with signs and symptoms of metastatic disease.
Measured: Baseline
Time to castration resistant state after beginning of hormonotherapy.
Measured: Baseline
Demographic data.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2013
- Study completionMay 2013
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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 407 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
- NCT01560858
- Sponsor's protocol ID
- A-92-52014-196
- Status last verified
- Jan 2019
- First submitted
- 20 Mar 2012
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Observational Study to Describe Treatment Patterns Among Patients With Prostate Cancer Prior to Diagnosis of a Castration-resistant State, in Routine Clinical Practice in Spain.
- ClinicalTrials.gov ID
- NCT01560858
- Acronym / sponsor ID
- A-92-52014-196
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 22 Mar 2012 (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 describe treatment patterns among patients with prostate cancer prior to diagnosis of castration-resistant state.
Study design
- Observational model
- Case only
- 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
- Community sample
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Patients with prostate cancer who had developed a castration resistant state in the last 24 months prior to starting the study
- Patient must give written informed consent before any study related procedure
Key exclusion criteria (1 listed)
- Patients with medical histories lacking data required to evaluate the study objectives
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
Prior treatment before progression to advanced or metastatic disease.
Time frame: Baseline
Number of participants with each category of treatment.
Treatment of advanced or metastatic disease.
Time frame: Baseline
Number of participants with each category of treatment.
4 secondary outcomes
Clinical management of Castration-Resistant Prostate Cancer (CRPC) patients in the clinical practice.
Time frame: Baseline
Number of CRPC patients with signs and symptoms of metastatic disease.
Time frame: Baseline
Time to castration resistant state after beginning of hormonotherapy.
Time frame: Baseline
Demographic data.
Time frame: Baseline
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 25 Jan 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
1 site 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 Ipsen at 1 site in Spain.
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 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 25 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 1 site in Spain. 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?
Prior treatment before progression to advanced or metastatic disease. (time frame: Baseline). 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 25 Jan 2019.