Prostatic CancerUROCORNCT01284608
Metabolic Changes in Prostate Cancer Patients With Androgen-ablation Therapy (AAT)
An observational study of Prostatic Cancer, run by AstraZeneca at 33 sites in Spain.
Trial summary
This is an observational, prospective, non-interventional and multi-centre study, to assess the impact of androgen ablation therapy in blood triglycerides, cholesterol and glucose, body fat distribution and fracture risk to ten years using FRAX model in patients with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Cancer
- How many people
- 197 participants
- Where
- 33 sitesSpain
- Study dates
- Mar 2011to Dec 2012
- 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: Prostate cancer patients in androgen-ablaction treatment in urological departments
Who may be able to join
- Prostate cancer patient requiring androgen-ablation treatment: LHRH analogs, surgical castration, antiandrogen treatment
- Provision of informed consent prior to conducting any study-related procedure
Who cannot join
- Patient involved in a Clinical Trial
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
Spain33 sites
Research Site
Albacete, Albacete
Research Site
Alcalá de Henares, Madrid
Research Site
Antequera, Malaga
Research Site
Aranda de Duero, Burgos
Research Site
Barakaldo, Vizcaya
Research Site
Barcelona, Barcelona
Research Site
Bilbao, Vizcaya
Research Site
Calatayud, Zaragoza
Research Site
Córdoba, Cordoba
Research Site
Coslada, Madrid
Research Site
Donostia / San Sebastian, Guipuzcoa
Research Site
El Ejido, Almeria
Research Site
El Hospitalet de Llobregat, Barcelona
Research Site
Ferrol, Coru?a
Research Site
Galdakao, Vizcaya
Research Site
Granada, Granada
Research Site
Guadalajara, Guadalajara
Research Site
Huercal Overa, Almeria
Research Site
Jaén, Jaen
Research Site
Logroño, La Rioja
Research Site
Madrid, Madrid
Research Site
Majadahonda, Madrid
Research Site
Mérida, Badajoz
Research Site
Miranda de Ebro, Burgos
Research Site
Monforte (casco Urbano), Lugo
Research Site
Osuna, Sevilla
Research Site
Palma de Mallorca, Balearic Islands
Research Site
Reus, Tarragona
Research Site
Sabadell, Barcelona
Research Site
San Sebastián de los Reyes, Madrid
Research Site
Toledo, Toledo
Research Site
Vigo, Pontevedra
Research Site
Zaragoza, Zaragoza
About this study
This is an observational, prospective, non-interventional and multi-centre study, to assess the impact of androgen ablation therapy in blood triglycerides, cholesterol and glucose, body fat distribution and fracture risk to ten years using FRAX model in patients with prostate cancer. The patients will be following for 12 months
- Conditions
- Prostatic Cancer
- Keywords
- Observational, prospective, metabolic changes, metabolic syndrome, diabetes, prostatic cancer, risk fracture
- Medical subject headings
- Prostatic Neoplasms, Metabolic Syndrome, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic syndrome
Measured: 3 months
Metabolic syndrome
Measured: 6 months
Metabolic syndrome
Measured: 12 months
Diabetes
Measured: 3 months
Diabetes
Measured: 6 months
Diabetes
Measured: 12 months
Secondary outcomes (1)
Fracture Risk Assessment Tool (FRAx) assessment
Measured: 0 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284608
- Sponsor's protocol ID
- NIS-OES-DUM-2010/1
- Acronym
- UROCOR
- Status last verified
- Dec 2012
- First submitted
- 26 Jan 2011
- Last updated
- 24 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Changes in Prostate Cancer Patients With Androgen-ablation Therapy (AAT)
- ClinicalTrials.gov ID
- NCT01284608
- Acronym / sponsor ID
- UROCOR / NIS-OES-DUM-2010/1
- Conditions
- Prostatic Cancer
- Keywords
- Observational, prospective, metabolic changes, metabolic syndrome, diabetes, prostatic cancer, risk fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Jan 2011 (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.
This is an observational, prospective, non-interventional and multi-centre study, to assess the impact of androgen ablation therapy in blood triglycerides, cholesterol and glucose, body fat distribution and fracture risk to ten years using FRAX model in patients with prostate cancer. The patients will be following for 12 months
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prostate cancer patients in androgen-ablaction treatment in urological departments
Key inclusion criteria (2 listed)
- Prostate cancer patient requiring androgen-ablation treatment: LHRH analogs, surgical castration, antiandrogen treatment
- Provision of informed consent prior to conducting any study-related procedure
Key exclusion criteria (1 listed)
- Patient involved in a Clinical Trial
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
Metabolic syndrome
Time frame: 3 months
Metabolic syndrome
Time frame: 6 months
Metabolic syndrome
Time frame: 12 months
Diabetes
Time frame: 3 months
Diabetes
Time frame: 6 months
Diabetes
Time frame: 12 months
1 secondary outcome
Fracture Risk Assessment Tool (FRAx) assessment
Time frame: 0 and 12 months
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 24 Dec 2012.
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Natural History Study of Early Life Exposures in Agriculture (ELEA)
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STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
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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.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Cancer, run by AstraZeneca at 33 sites 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 2 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 24 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites 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?
Metabolic syndrome (time frame: 3 months). The study lists 6 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 24 Dec 2012.