Prostate CancerSorseNCT00668083
Observational Retrospective Trial on Sequential Hormonal Therapy in Patients With Prostate Cancer
An observational study of Prostate Cancer, run by AstraZeneca at 12 sites in Italy.
Trial summary
Observational Retrospective trial on sequential hormonal therapy in patients with Prostate Cancer Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 214 participants
- Where
- 12 sitesItaly
- Study dates
- Sep 2007to Jul 2008
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: THIS IS A RETROSPECTIVE TRIAL THEREFORE CLINICAL DATA ARE FROM ARCHIVED CLINICAL RECORD OF PATIENTS WHO WERE ADMITTED IN THE HOSPITAL.
Who may be able to join
- non metastatic Prostate Cancer
- previous treatment with bicalutamide 150mg
- biochemical relapse/progression
Who cannot join
- use of other treatments for Prostate Cancer
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Italy12 sites
Research Site
Acquaviva delle Fonti
Research Site
Ancona
Research SIte
Florence
Research Site
Matera
Research Site
Messina
Research Site
Milan
Research Site
Monza
Research Site
Naples
Research Site
Pisa
Research Site
Portogruaro
Research Site
Roma
Research Site
Viareggio
About this study
Official title: Observational Retrospective Trial on Sequential Hormonal Therapy in Patients
Observational Retrospective trial on sequential hormonal therapy in patients with Prostate Cancer
- Conditions
- Prostate Cancer
- Keywords
- second line, Prostate Cancer, bicalutamide, biochemical relapse/progression in patients with Prostate Cancer treated with bicalutamide 150mg
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Hormonal sensitivity to second line treatment for CaP after Bicalutamide
Measured: six months
Secondary outcomes (1)
median duration of second and third line treatments;
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startSep 2007
- Primary completionOct 2007
- Study completionJul 2008
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 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Davide Meani, MD, Study director, AstraZeneca Medical Dept
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668083
- Sponsor's protocol ID
- NIS-OIT-CAS-2007/1
- Acronym
- Sorse
- Status last verified
- Dec 2010
- First submitted
- 24 Apr 2008
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Retrospective Trial on Sequential Hormonal Therapy in Patients
- ClinicalTrials.gov ID
- NCT00668083
- Acronym / sponsor ID
- Sorse / NIS-OIT-CAS-2007/1
- Conditions
- Prostate Cancer
- Keywords
- second line, Prostate Cancer, bicalutamide, biochemical relapse/progression in patients with Prostate Cancer treated with bicalutamide 150mg
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 28 Apr 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.
Observational Retrospective trial on sequential hormonal therapy in patients with Prostate Cancer
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- THIS IS A RETROSPECTIVE TRIAL THEREFORE CLINICAL DATA ARE FROM ARCHIVED CLINICAL RECORD OF PATIENTS WHO WERE ADMITTED IN THE HOSPITAL.
Key inclusion criteria (3 listed)
- non metastatic Prostate Cancer
- previous treatment with bicalutamide 150mg
- biochemical relapse/progression
Key exclusion criteria (1 listed)
- use of other treatments for Prostate Cancer
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
Hormonal sensitivity to second line treatment for CaP after Bicalutamide
Time frame: six months
1 secondary outcome
median duration of second and third line treatments;
Time frame: six 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 10 Dec 2010.
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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.
Davide Meani, MD study director
AstraZeneca Medical Dept
12 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 AstraZeneca at 12 sites in Italy.
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 10 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy. 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?
Hormonal sensitivity to second line treatment for CaP after Bicalutamide (time frame: six months). 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 10 Dec 2010.