Advanced Prostate CancerNCT00871585

Evaluation of Prostate-Specific Antigen (PSA) Levels in Patients With Advanced Prostate Cancer Treated With Bicalutamide

An observational study of Advanced Prostate Cancer, run by AstraZeneca at 15 sites in Croatia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Prospective, non-comparative, non-interventional, observational study to collect and analyse real life environment data on advanced prostate cancer patients receiving combination treatment of medical or surgical castration and bicalutamide according to routine medical practice in Croatia. Read more about this study

Who is it for?: Ages 40 years and older, men only
Conditions the study is for: Advanced Prostate Cancer
How many people: 340 participants
Where: 15 sitesCroatia
Study dates: Mar 2009to Jan 2010
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 40 years and older
Men only
No healthy volunteers
Adult, Older adult

Study population: 400 advanced prostate cancer patients (outpatients or hospitalized) treated with bicalutamide in combination with medical or surgical castration according to standard clinical practice

Who may be able to join

Patients with diagnosis of advanced prostate cancer
Patients who are already treated with bicalutamide for at least 4 weeks and maximum 12 weeks
Patients capable of signing ICF

Who cannot join

Patients with hypersensitivity to bicalutamide
Patients on therapy with terfenadin, astemizol or cisapride
Participation in a clinical study during the last 30 days

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

Croatia15 sites

Research Site
Čakovec
Research Site
Dubrovnik
Research Site
Karlovac
Research Site
Pula
Research Site
Rijeka
Research Site
Šibenik
Research Site
Sisak
Research Site
Slavonski Brod
Research Site
Split
Research Site
Vinkovci
Research Site
Virovitica
Research Site
Vukovar
Research Site
Zabok
Research Site
Zadar
Research Site
Zagreb

Other trials in Croatia

About this study

Official title: Non-interventional Observational Study to Evaluate Change of PSA Levels in Patients With Advanced Prostate Cancer Treated With Bicalutamide in Combination With Medical or Surgical Castration

Conditions: Advanced Prostate Cancer
Keywords: bicalutamide, PSA, advanced prostate cancer

What is being measured

The primary outcome is the main question the study is designed to answer.

To evaluate change in PSA level following 4-9 months of bicalutamide therapy
Measured: PSA - 2 measures (at the time of bicalutamdie introduction and 4-9 m following bicalutamide)

Secondary outcomes (6)

bicalutamide prescribing practice based on prostate cancer stage
Measured: 1 measure (at the time of bicalutamde th introduction)
to evaluate PSA level after 4-12 weeks of bicalutamide therapy
Measured: PSA - 1 measures (1-3 m following bicalutamide)
to asses time to disease progression based on PSA values
Measured: PSA - 3 measures (at the time of bicalutamdie introduction, 1-3 m and 4-9 m following bicalutamide)
to evaluate percentage of patients with disease progression
Measured: 2 measures at 1st and 2nd visit
to evaluate withdrawals due to adverse events
Measured: 2 measures, at 1st and 2nd visit
to evaluate withdrawals due to Croatian Institute for Health Insurance guidelines for bicalutamide prescription
Measured: 2 measures, at 1st and 2nd visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Jan 2010

First posted30 Mar 2009 (estimated)
Study startMar 2009
Primary completionJan 2010
Study completionJan 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced 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: Prospective
Enrolment: 340 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00871585
Sponsor's protocol ID: NIS-OHR-CAS-2008/1
Status last verified: Apr 2010
First submitted: 27 Mar 2009
Last updated: 15 Apr 2010
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
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RecruitingPhase 2
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RecruitingPhase 2
Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy in Black Men With Locally Advanced, Biochemically Recurrent and Metastatic Prostate Cancer
Biochemically Recurrent Prostate Carcinoma, Locally Advanced Prostate Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor

All Advanced Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-interventional Observational Study to Evaluate Change of PSA Levels in Patients With Advanced Prostate Cancer Treated With Bicalutamide in Combination With Medical or Surgical Castration
ClinicalTrials.gov ID: NCT00871585
Acronym / sponsor ID: NIS-OHR-CAS-2008/1
Conditions: Advanced Prostate Cancer
Keywords: bicalutamide, PSA, advanced prostate cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 340 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 30 Mar 2009 (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 design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 40 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 400 advanced prostate cancer patients (outpatients or hospitalized) treated with bicalutamide in combination with medical or surgical castration according to standard clinical practice

Key inclusion criteria (3 listed)

Patients with diagnosis of advanced prostate cancer
Patients who are already treated with bicalutamide for at least 4 weeks and maximum 12 weeks
Patients capable of signing ICF

Key exclusion criteria (3 listed)

Patients with hypersensitivity to bicalutamide
Patients on therapy with terfenadin, astemizol or cisapride
Participation in a clinical study during the last 30 days

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

To evaluate change in PSA level following 4-9 months of bicalutamide therapy
Time frame: PSA - 2 measures (at the time of bicalutamdie introduction and 4-9 m following bicalutamide)

6 secondary outcomes

bicalutamide prescribing practice based on prostate cancer stage
Time frame: 1 measure (at the time of bicalutamde th introduction)
to evaluate PSA level after 4-12 weeks of bicalutamide therapy
Time frame: PSA - 1 measures (1-3 m following bicalutamide)
to asses time to disease progression based on PSA values
Time frame: PSA - 3 measures (at the time of bicalutamdie introduction, 1-3 m and 4-9 m following bicalutamide)
to evaluate percentage of patients with disease progression
Time frame: 2 measures at 1st and 2nd visit
to evaluate withdrawals due to adverse events
Time frame: 2 measures, at 1st and 2nd visit
to evaluate withdrawals due to Croatian Institute for Health Insurance guidelines for bicalutamide prescription
Time frame: 2 measures, at 1st and 2nd visit

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 15 Apr 2010.

Related trials for Advanced Prostate Cancer

RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy in Black Men With Locally Advanced, Biochemically Recurrent and Metastatic Prostate Cancer
Biochemically Recurrent Prostate Carcinoma, Locally Advanced Prostate Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor

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.

Ana Marija Gjurovic study director

AstraZeneca

Andreja Hasenohrl study chair

AstraZeneca

15 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 Cancer, run by AstraZeneca at 15 sites in Croatia.

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 3 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 15 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Croatia. 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?

To evaluate change in PSA level following 4-9 months of bicalutamide therapy (time frame: PSA - 2 measures (at the time of bicalutamdie introduction and 4-9 m following bicalutamide)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00871585.

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 15 Apr 2010.