Prostate CancerPhase 3NCT00233610
Two Different Regimens of Nolvadex in Preventing Gynecomastia Induced by Casodex 150 mg in Patients With Prostate Cancer
A Phase 3 study testing Bicalutamide and Tamoxifen in people with Prostate Cancer, run by AstraZeneca at 11 sites in Italy.
Trial summary
The aim of the study is to investigate the efficacy of different dosing and scheduling of Nolvadex in preventing gynecomastia/mastalgia induced by Casodex 150 mg monotherapy in patients with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Bicalutamide and Tamoxifen
- How many people
- 180 participants
- Where
- 11 sitesItaly
- Study dates
- Dec 2003to Oct 2007
- Phase
- Phase 3
- 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed prostate cancer
- Locally advanced prostate cancer patients suitable for Casodex 150 mg monotherapy
Who cannot join
- Age > 75 yrs
- No metastatic disease (M1).
- No presence of gynaecomastia and/or mastalgia at screening
- No therapy with medications able to provoke gynaecomastia and/or mastalgia within 6 months of trial entry.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Italy11 sites
Research Site
Bagno a Ripoli, FI
Research Site
Bari, BA
Research Site
Bologna, BO
Research Site
Catania, CT
Research Site
Como
Research Site
Florence, FI
Research Site
Genova, GE
Research Site
Parma, PR
Research Site
Pisa, PI
Research Site
Roma, Roma
Research Site
Udine, UD
About this study
Official title: A Comparative Trial of the Efficacy of Two Different Nolvadex (NDX) Dosing and Scheduling Regimens in Preventing Gynecomastia Induced by Casodex (CDX) 150 Monotherapy in Prostate Cancer Patients. An Open, Multicenter, Phase III Trial.
The aim of the study is to investigate the efficacy of different dosing and scheduling of Nolvadex in preventing gynecomastia/mastalgia induced by Casodex 150 mg monotherapy in patients with prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Bicalutamide, Tamoxifen
- Keywords
- Casodex monotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BicalutamideDrug
TamoxifenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Gynecomastia and Breast pain at 2, 6 months and every 6 months thereafter and/or at withdrawal visit.
Secondary outcomes (1)
Sexual functioning, Quality of life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2005 (estimated)
- Study startDec 2003
- Primary completionOct 2007
- Study completionOct 2007
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Astra Zeneca, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233610
- Sponsor's protocol ID
- 7054IT/0003
- Status last verified
- Jan 2011
- First submitted
- 4 Oct 2005
- Last updated
- 27 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Trial of the Efficacy of Two Different Nolvadex (NDX) Dosing and Scheduling Regimens in Preventing Gynecomastia Induced by Casodex (CDX) 150 Monotherapy in Prostate Cancer Patients. An Open, Multicenter, Phase III Trial.
- ClinicalTrials.gov ID
- NCT00233610
- Acronym / sponsor ID
- 7054IT/0003
- Conditions
- Prostate Cancer
- Keywords
- Casodex monotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 6 Oct 2005 (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 aim of the study is to investigate the efficacy of different dosing and scheduling of Nolvadex in preventing gynecomastia/mastalgia induced by Casodex 150 mg monotherapy in patients with prostate cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically confirmed prostate cancer
- Locally advanced prostate cancer patients suitable for Casodex 150 mg monotherapy
Key exclusion criteria (4 listed)
- Age > 75 yrs
- No metastatic disease (M1).
- No presence of gynaecomastia and/or mastalgia at screening
- No therapy with medications able to provoke gynaecomastia and/or mastalgia within 6 months of trial entry.
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 |
|---|---|---|
| Bicalutamide | Drug | – |
| Tamoxifen | Drug | – |
Primary outcome
Incidence of Gynecomastia and Breast pain at 2, 6 months and every 6 months thereafter and/or at withdrawal visit.
1 secondary outcome
Sexual functioning, Quality of life.
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 27 Jan 2011.
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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.
Astra Zeneca study director
AstraZeneca
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bicalutamide and Tamoxifen in people with Prostate Cancer, run by AstraZeneca at 11 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 2 inclusion and 4 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 27 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of Gynecomastia and Breast pain at 2, 6 months and every 6 months thereafter and/or at withdrawal visit.. 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 27 Jan 2011.