Non-metastatic Prostate CancerPhase 3NCT00657904
Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer
A Phase 3 study testing Bicalutamide in people with Non-metastatic Prostate Cancer, run by AstraZeneca at 85 sites in 2 countries.
Trial summary
The purpose of this trial is to study the effect - in terms of time to progression and overall survival - of 2 years of adjuvant bicalutamide 150mg monotherapy, versus placebo, in subjects with histologically or cytologically confirmed non-metastatic adenocarcinoma of the prostate gland. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Non-metastatic Prostate Cancer
- What is being tested?
- Bicalutamide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,618 participants
- Where
- 85 sitesin 2 countries
- Study dates
- Aug 1995to Aug 2008
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prostate cancer in the early stage of disease
- Prostate removed and/or radiation therapy to the prostate area
Who cannot join
- Previous systemic therapy for prostate cancer
- Previous history of another form of cancer (not prostate) within 5 years of study start.
Trial locations and contacts
85 sites in 2 countries.
85 sites in 2 countries
United States72 sites
Research Site
Albany, New York
Research Site
Ann Arbor, Michigan
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Asheville, North Carolina
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Atlanta, Georgia
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Aventura, Florida
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Bay Pines, Florida
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Berkeley, California
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Birmingham, Alabama
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Boca Raton, Florida
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Burlington, Massachusetts
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Cheyenne, Wyoming
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Chicago, Illinois
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Cincinnati, Ohio
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Cordova, Tennessee
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Dallas, Texas
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Danville, Virginia
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Daytona Beach, Florida
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Denver, Colorado
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Detroit, Michigan
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Durham, North Carolina
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Fort Myers, Florida
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Fort Wayne, Indiana
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Gainesville, Florida
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Greenbelt, Maryland
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Greenwood, Indiana
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Hattiesburg, Mississippi
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Houston, Texas
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Iowa City, Iowa
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Jackson, Mississippi
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Kansas City, Kansas
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Laguna Woods, California
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Lancaster, Pennsylvania
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Lebanon, New Hampshire
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Louisville, Kentucky
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Madison, Wisconsin
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Manhasset, New York
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Miami, Florida
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Middlebury, Connecticut
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Milwaukee, Wisconsin
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Mobile, Alabama
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Nashville, Tennessee
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New Haven, Connecticut
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New York, New York
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Newport Beach, California
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Newtown, Massachusetts
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Ocala, Florida
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Omaha, Nebraska
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Philadelphia, Pennsylvania
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Portland, Oregon
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Raleigh, North Carolina
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Richmond, Virginia
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Rochester, Minnesota
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Rochester, New York
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Rockville, Maryland
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Saint Augustine, Florida
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Salt Lake City, Utah
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San Antonio, Texas
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San Diego, California
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San Francisco, California
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Santa Monica, California
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Scottsdale, Arizona
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Seattle, Washington
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Shreveport, Louisiana
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St Louis, Missouri
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Syracuse, New York
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The Bronx, New York
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Thousand Oaks, California
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Torrance, California
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Tucson, Arizona
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Van Nuys, California
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Virginia Beach, Virginia
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Washington D.C., District of Columbia
Canada13 sites
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Calgary, Alberta
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Edmonton, Alberta
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Halifax, Nova Scotia
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Hamilton, Ontario
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Kingston, Ontario
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London, Ontario
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Montreal, Quebec
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North York, Ontario
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Oakville, Ontario
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Québec
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Toronto, Ontario
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Victoria, British Columbia
Research Site
Winnipeg, Manitoba
About this study
Official title: A Randomized Double-Blind Comparative Trial of Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer.
The purpose of this trial is to study the effect - in terms of time to progression and overall survival - of 2 years of adjuvant bicalutamide 150mg monotherapy, versus placebo, in subjects with histologically or cytologically confirmed non-metastatic adenocarcinoma of the prostate gland.
- Conditions
- Non-metastatic Prostate Cancer
- Being tested
- Bicalutamide, Placebo
- Keywords
- androgen antagonists, prostate neoplasms
- 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
Also called Casodex™
150mg daily
PlaceboDrug
once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Bicalutamide |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical progression
Measured: Throughout study period
Overall patient survival
Measured: Throughout study period
Secondary outcomes (3)
Time to treatment failure
Measured: Throughout study period
Serum prostate-specific antigen
Measured: Initial study period up to 2006 amended protocol
Tolerability in terms of adverse events and laboratory parameters
Measured: Throughout study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startAug 1995
- Primary completionJul 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-metastatic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3,618 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William See, Principal investigator, Medical College of WisconsinDavid G. McLeod, Principal investigator, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657904
- Sponsor's protocol ID
- D6876C00023
- Other IDs
- 7054IL/0023
- Status last verified
- Jun 2012
- First submitted
- 7 Apr 2008
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Iversen P, McLeod DG, See WA, Morris T, Armstrong J, Wirth MP; Casodex Early Prostate Cancer Trialists' Group. Antiandrogen monotherapy in patients with localized or locally advanced prostate cancer: final results from the bicalutamide Early Prostate Cancer programme at a median follow-up of 9.7 years. BJU Int. 2010 Apr;105(8):1074-81. doi: 10.1111/j.1464-410X.2010.09319.x.
PubMed 22129214
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Comparative Trial of Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer.
- ClinicalTrials.gov ID
- NCT00657904
- Acronym / sponsor ID
- D6876C00023
- Conditions
- Non-metastatic Prostate Cancer
- Keywords
- androgen antagonists, prostate neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,618 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 1995
- Primary completion
- Jul 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 14 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.
The purpose of this trial is to study the effect - in terms of time to progression and overall survival - of 2 years of adjuvant bicalutamide 150mg monotherapy, versus placebo, in subjects with histologically or cytologically confirmed non-metastatic adenocarcinoma of the prostate gland.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Bicalutamide |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Prostate cancer in the early stage of disease
- Prostate removed and/or radiation therapy to the prostate area
Key exclusion criteria (2 listed)
- Previous systemic therapy for prostate cancer
- Previous history of another form of cancer (not prostate) within 5 years of study start.
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 |
|---|---|---|
| BicalutamideAlso: Casodex™150mg daily | Drug | 1 |
| Placeboonce daily | Drug | 2 |
Primary outcome
Time to clinical progression
Time frame: Throughout study period
Overall patient survival
Time frame: Throughout study period
3 secondary outcomes
Time to treatment failure
Time frame: Throughout study period
Serum prostate-specific antigen
Time frame: Initial study period up to 2006 amended protocol
Tolerability in terms of adverse events and laboratory parameters
Time frame: Throughout study period
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 6 Jun 2012.
- Derived from this study: PubMed 22129214Iversen P, McLeod DG, See WA, Morris T, Armstrong J, Wirth MP; Casodex Early Prostate Cancer Trialists' Group. Antiandrogen monotherapy in patients with localized or locally advanced prostate cancer: final results from the bicalutamide Early Prostate Cancer programme at a median follow-up of 9.7 years. BJU Int. 2010 Apr;105(8):1074-81. doi: 10.1111/j.1464-410X.2010.09319.x.
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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.
William See principal investigator
Medical College of Wisconsin
David G. McLeod principal investigator
Walter Reed Army Medical Center
85 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bicalutamide in people with Non-metastatic Prostate Cancer, run by AstraZeneca at 85 sites in 2 countries.
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 2 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 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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?
Time to clinical progression (time frame: Throughout study period). 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?
On the ClinicalTrials.gov record for NCT00657904, which also lists 1 linked publication.
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 6 Jun 2012.