Casodex vs Placebo in Non-Metastatic Early Prostate Cancer (SPCG6)
May 26, 2009 updated by: AstraZeneca
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1218
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aalborg, Denmark
- Research Site
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Charlottenlund, Denmark
- Research Site
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Esbjerg, Denmark
- Research Site
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Frederiksberg, Denmark
- Research Site
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Frederikssund, Denmark
- Research Site
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Glostrup, Denmark
- Research Site
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Herlev, Denmark
- Research Site
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Holbuk, Denmark
- Research Site
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Kobenhavn, Denmark
- Research Site
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Nyk Bing Falster, Denmark
- Research Site
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Odense, Denmark
- Research Site
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Orhus, Denmark
- Research Site
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Randers, Denmark
- Research Site
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S Nderborg, Denmark
- Research Site
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Helsinki, Finland
- Research Site
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Joensuu, Finland
- Research Site
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Kokkola, Finland
- Research Site
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Kuopio, Finland
- Research Site
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Lahti, Finland
- Research Site
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Lappeenranta, Finland
- Research Site
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Oys (oulu), Finland
- Research Site
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Tampere, Finland
- Research Site
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Turku, Finland
- Research Site
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Bergen, Norway
- Research Site
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Bodu, Norway
- Research Site
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Drammen, Norway
- Research Site
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Fredrikstad, Norway
- Research Site
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Harstad, Norway
- Research Site
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Kristiansand, Norway
- Research Site
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Lesund, Norway
- Research Site
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Levanger, Norway
- Research Site
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Lillehammer, Norway
- Research Site
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Oslo, Norway
- Research Site
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Porsgrunn, Norway
- Research Site
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RUD, Norway
- Research Site
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Stavanger, Norway
- Research Site
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Strummen, Norway
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Tromsu, Norway
- Research Site
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Trondheim, Norway
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Tunsberg, Norway
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Goteborg, Sweden
- Research Site
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Govle, Sweden
- Research Site
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Helsingborg, Sweden
- Research Site
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Hudiksvall, Sweden
- Research Site
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Junkoping, Sweden
- Research Site
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Kristinehamn, Sweden
- Research Site
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Luleo, Sweden
- Research Site
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Malmu, Sweden
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Norrkoping, Sweden
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Stockholm, Sweden
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Urebro, Sweden
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Ustersund, Sweden
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VoSTEROS, Sweden
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Vostervik, Sweden
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Clinical diagnosis of non-metastatic cancer of the prostate gland
- Patient to be 18 years and above
Exclusion Criteria:
- Previous systemic therapy for prostate cancer
- Previous history of another form of cancer (not prostate) within 5 years of study start.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: B
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150mg p.o. daily
Other Names:
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Placebo Comparator: A
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Time to clinical progression
Time Frame: Throughout study period
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Throughout study period
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Survival
Time Frame: Throughout study period
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Throughout study period
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Time to treatment failure
Time Frame: Throughout study period
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Throughout study period
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Tolerability in terms of adverse events and laboratory parameters
Time Frame: Throughout study period
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Throughout study period
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Prostate-specific antigen
Time Frame: Initial study period up to 2005 amended protocol
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Initial study period up to 2005 amended protocol
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter Iversen, MD, Department of Urology Rigshospitalet Copenhagen Denmark
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 1995
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
May 2, 2008
First Submitted That Met QC Criteria
May 5, 2008
First Posted (Estimate)
May 6, 2008
Study Record Updates
Last Update Posted (Estimate)
May 27, 2009
Last Update Submitted That Met QC Criteria
May 26, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D6876C00025
- 7054IL/0025
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.