Non-Metastatic Prostate CancerPhase 3SPCG6NCT00672282
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 54 sites in 4 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
- 1,218 participants
- Where
- 54 sitesin 4 countries
- Study dates
- Oct 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
54 sites in 4 countries.
54 sites in 4 countries
Norway17 sites
Research Site
Bergen
Research Site
BODU
Research Site
Drammen
Research Site
Fredrikstad
Research Site
Harstad
Research Site
Kristiansand
Research Site
Lesund
Research Site
Levanger
Research Site
Lillehammer
Research Site
Oslo
Research Site
Porsgrunn
Research Site
Rud
Research Site
Stavanger
Research Site
Strummen
Research Site
Tromsu
Research Site
Trondheim
Research Site
Tunsberg
Denmark14 sites
Research Site
Aalborg
Research Site
Charlottenlund
Research Site
Copenhagen
Research Site
Esbjerg
Research Site
Frederiksberg
Research Site
Frederikssund
Research Site
Glostrup Municipality
Research Site
Herlev
Research Site
Holbuk
Research Site
NYK BING Falster
Research Site
Odense
Research Site
Orhus
Research Site
Randers
Research Site
S Nderborg
Sweden14 sites
Research Site
Gothenburg
Research Site
Govle
Research Site
Helsingborg
Research Site
Hudiksvall
Research Site
Junkoping
Research Site
Kristinehamn
Research Site
Luleå
Research Site
Malmu
Research Site
Norrköping
Research Site
Stockholm
Research Site
Urebro
Research Site
Ustersund
Research Site
VoSTEROS
Research Site
Vostervik
Finland9 sites
Research Site
Helsinki
Research Site
Joensuu
Research Site
Kokkola
Research Site
Kuopio
Research Site
Lahti
Research Site
Lappeenranta
Research Site
OYS (oulu)
Research Site
Tampere
Research Site
Turku
About this study
Official title: A Randomized, Double-Blind, Parallel-Group Trial Comparing 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.
Survival
Measured: Throughout study period
Time to clinical progression
Measured: Throughout study period
Secondary outcomes (3)
Tolerability in terms of adverse events and laboratory parameters
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 posted6 May 2008 (estimated)
- Study startOct 1995
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 1,218 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Scandinavian Prostate Cancer Group
- Investigators
- Peter Iversen, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672282
- Sponsor's protocol ID
- D6876C00025
- Other IDs
- 7054IL/0025
- Acronym
- SPCG6
- Status last verified
- Mar 2009
- First submitted
- 2 May 2008
- Last updated
- 27 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Thomsen FB, Brasso K, Berg KD, Gerds TA, Johansson JE, Angelsen A, Tammela TL, Iversen P; Scandinavian Prostate Cancer Group. Association between PSA kinetics and cancer-specific mortality in patients with localised prostate cancer: analysis of the placebo arm of the SPCG-6 study. Ann Oncol. 2016 Mar;27(3):460-6. doi: 10.1093/annonc/mdv607. Epub 2015 Dec 17.
PubMed 26681677Iversen 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 27 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group Trial Comparing Casodex 150mg Once Daily With Placebo in Patients With Non-Metastatic Prostate Cancer.
- ClinicalTrials.gov ID
- NCT00672282
- Acronym / sponsor ID
- SPCG6 / D6876C00025
- Conditions
- Non-Metastatic Prostate Cancer
- Keywords
- androgen antagonists, prostate neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,218 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Scandinavian Prostate Cancer Group
- Study start
- Oct 1995
- Study completion
- Aug 2008 (actual)
- First posted
- 6 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
Survival
Time frame: Throughout study period
Time to clinical progression
Time frame: Throughout study period
3 secondary outcomes
Tolerability in terms of adverse events and laboratory parameters
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 27 May 2009.
- Derived from this study: PubMed 26681677Thomsen FB, Brasso K, Berg KD, Gerds TA, Johansson JE, Angelsen A, Tammela TL, Iversen P; Scandinavian Prostate Cancer Group. Association between PSA kinetics and cancer-specific mortality in patients with localised prostate cancer: analysis of the placebo arm of the SPCG-6 study. Ann Oncol. 2016 Mar;27(3):460-6. doi: 10.1093/annonc/mdv607. Epub 2015 Dec 17.
- 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.
Peter Iversen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
54 sites in 4 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 54 sites in 4 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 27 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Norway, Denmark, Sweden, Finland. 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?
Survival (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 NCT00672282, which also lists 2 linked publications.
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 May 2009.