Non-Metastatic Prostate CancerPhase 3CapriNCT00673205
(Bicalutamide) Casodex vs Placebo in Non-metastatic Early Prostate Cancer
A Phase 3 study testing Bicalutamide in people with Non-Metastatic Prostate Cancer, run by AstraZeneca at 128 sites in 16 countries.
Trial summary
The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting. 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
- 3,588 participants
- Where
- 128 sitesin 16 countries
- Study dates
- Sep 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
- Clinical diagnosis of non-metastatic cancer of the prostate gland
- Patient to be 18 years and above
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
128 sites in 16 countries.
128 sites in 16 countries
United Kingdom23 sites
Research Site
Barnet, Hertfordshire
Research Site
Belfast, Northern Ireland
Research Site
Birmingham, West Midlands
Research Site
Bolton
Research Site
Bristol
Research Site
Cardiff
Research Site
Cleveland
Research Site
Colchester, Essex
Research Site
Eastbourne, Sussex
Research Site
Edinburgh
Research Site
Falkirk
Research Site
Gwent, South Wales
Research Site
Hull
Research Site
Kent
Research Site
Leeds
Research Site
London
Research Site
Manchester
Research Site
Plymouth
Research Site
Reading, Berkshire
Research Site
Sheffield
Research Site
Shrewsbury
Research Site
Taunton, Somerset
Research Site
Tooting, London
Italy18 sites
Research Site
Anagni, FR
Research Site
Bari, BA
Research Site
Belluno, BL
Research Site
Bergamo, BG
Research Site
Bologna, BO
Research Site
Brescia, BS
Research Site
Carpi, MO
Research Site
Cesena, FO
Research Site
Como, CO
Research Site
Dolo, VE
Research Site
Fidenza, PR
Research Site
Portogruaro, VE
Research Site
Roma, Roma
Research Site
Siena, SI
Research Site
Torino, TO
Research Site
Treviso, TV
Research Site
Udine, UD
Research Site
Varese, VA
Spain18 sites
Research Site
A Coruña, Galicia
Research Site
Alcalá de Henares, Madrid
Research Site
Badalona(barcelona), Catalonia
Research Site
Barcelona, Catalonia
Research Site
Bilbao, Basque Country
Research Site
Getafe, Madrid
Research Site
Granada, Andalusia
Research Site
Guadalajara, Castille-La Mancha
Research Site
Hospitalet de Llobregat(barcel, Catalonia
Research Site
Madrid, Madrid
Research Site
Málaga, Andalusia
Research Site
Oviedo, Principality of Asturias
Research Site
Pamplona, Navarre
Research Site
Salamanca, Castille and León
Research Site
San Juan(alicante), Valencia
Research Site
Seville, Andalusia
Research Site
Valencia, Valencia
Research Site
Vigo(pontevedra), Galicia
Netherlands13 sites
Research Site
Amsterdam
Research Site
Breda
Research Site
Capelle aan den IJssel
Research Site
Eindhoven
Research Site
Enschede
Research Site
Gouda
Research Site
Heerlen
Research Site
Maastricht
Research Site
Nijmegen
Research Site
Roosendaal
Research Site
Rotterdam
Research Site
Spijkenisse
Research Site
Utrecht
Germany12 sites
Research Site
Berlin
Research Site
Bonn
Research Site
Dresden
Research Site
Freiburg im Breisgau
Research Site
Heidelberg
Research Site
Jena
Research Site
Lübeck
Research Site
Lüdenscheid
Research Site
Mannheim
Research Site
München
Research Site
Regensburg
Research Site
Sigmaringen
Belgium9 sites
Research Site
Antwerp
Research Site
Bruges
Research Site
Brussels
Research Site
Ghent
Research Site
Kortrijk
Research Site
Leuven
Research Site
Mons
Research Site
Ostend
Research Site
Seraing
South Africa8 sites
Research Site
Bloemfontein, South Africa
Research Site
Cape Town
Research Site
Durban
Research Site
George
Research Site
Johannesburg
Research Site
Pietermarizberg
Research Site
Pretoria
Research Site
Somerset West, Cape Town
Austria5 sites
Research Site
Graz
Research Site
Linz
Research Site
Mistelbach
Research Site
Oberwart
Research Site
Sankt Pölten
Portugal5 sites
Research Site
Almada
Research Site
Coimbra
Research Site
Lisbon
Research Site
Porto
Research Site
Vila Nova de Gaia
Czechia4 sites
Research Site
Brno
Research Site
Hradec Králové
Research Site
Olomouc
Research Site
Prague
Israel4 sites
Research Site
Haifa
Research Site
Petah Tikva
Research Site
Tel Aviv
Research Site
Tel HaShomer
Hungary3 sites
Research Site
Budapest
Research Site
Miskolc
Research Site
Nyíregyháza
Australia2 sites
Research Site
East Melbourne, Victoria
Research Site
Wooloongabba, Queensland
About this study
Official title: A Randomized, Double-Blind, Parallel-Group Trial Comparing Bicalutamide (Casodex) 150mg Once Daily With Placebo in Patients With Non-metastatic Prostate Cancer
The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.
- 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 p.o. daily
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Not described Receives: Drug: Placebo |
| B | Active comparator | Not described Receives: Drug: Bicalutamide |
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
Tolerability in terms of adverse events and laboratory parameters
Measured: Throughout study period
Secondary outcomes (3)
Survival
Measured: Throughout study period
Time to treatment failure
Measured: Throughout study period
Prostate-specific antigen
Measured: Initial study period up to 2005 amended protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startSep 1995
- Primary completionAug 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
- 3,588 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Manfred P Wirth, Professor, Principal investigator, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673205
- Sponsor's protocol ID
- D6876C00024
- Other IDs
- 7054IL/0024
- Acronym
- Capri
- Status last verified
- Dec 2010
- First submitted
- 2 May 2008
- Last updated
- 10 Dec 2010
- 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 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group Trial Comparing Bicalutamide (Casodex) 150mg Once Daily With Placebo in Patients With Non-metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT00673205
- Acronym / sponsor ID
- Capri / D6876C00024
- Conditions
- Non-Metastatic Prostate Cancer
- Keywords
- androgen antagonists, prostate neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,588 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 1995
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 7 May 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 of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.
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 |
|---|---|---|
| A | Placebo comparator | Drug: Placebo |
| B | Active comparator | Drug: Bicalutamide |
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)
- Clinical diagnosis of non-metastatic cancer of the prostate gland
- Patient to be 18 years and above
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: Casodex150mg p.o. daily | Drug | B |
| Placebo | Drug | A |
Primary outcome
Time to clinical progression
Time frame: Throughout study period
Tolerability in terms of adverse events and laboratory parameters
Time frame: Throughout study period
3 secondary outcomes
Survival
Time frame: Throughout study period
Time to treatment failure
Time frame: Throughout study period
Prostate-specific antigen
Time frame: Initial study period up to 2005 amended protocol
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.
- 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.
Manfred P Wirth, Professor principal investigator
Technische Universität Dresden
128 sites in 16 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 128 sites in 16 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 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 128 sites in United Kingdom, Italy, Spain, Netherlands, Germany and 11 more countries. 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 NCT00673205, 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 10 Dec 2010.