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NCT00672282 Clinical Trial

Casodex vs Placebo in Non-Metastatic Early Prostate Cancer

Non-Metastatic Prostate Cancer Clinical Trial

— SPCG6  

Official title:
A Randomized, Double-Blind, Parallel-Group Trial Comparing Casodex 150mg Once Daily With Placebo in Patients With Non-Metastatic Prostate Cancer.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00672282
Other study ID # D6876C00025
Secondary ID 7054IL/0025
Status Completed
Phase Phase 3
First received May 2, 2008
Last updated May 26, 2009
Start date October 1995
Est. completion date August 2008

Study information
Verified date March 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: National Board of HealthDenmark: Ministry of HealthFinland: Ministry of Social Affairs and HealthFinland: Finnish Medicines AgencyNorway: Data Protection AuthorityNorway: Directorate of HealthNorway: Norwegian Institute of Public HealthNorway: Norwegian Medicines AgencySweden: Medical Products AgencySweden: Swedish National Council on Medical EthicsSweden: The National Board of Health and Welfare
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 1218
Est. completion date August 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Bicalutamide
150mg p.o. daily
• Placebo

Locations
Country Name City State
Denmark Research Site Aalborg
Denmark Research Site Charlottenlund
Denmark Research Site Esbjerg
Denmark Research Site Frederiksberg
Denmark Research Site Frederikssund
Denmark Research Site Glostrup
Denmark Research Site Herlev
Denmark Research Site Holbuk
Denmark Research Site Kobenhavn
Denmark Research Site Nyk Bing Falster
Denmark Research Site Odense
Denmark Research Site Orhus
Denmark Research Site Randers
Denmark Research Site S Nderborg
Finland Research Site Helsinki
Finland Research Site Joensuu
Finland Research Site Kokkola
Finland Research Site Kuopio
Finland Research Site Lahti
Finland Research Site Lappeenranta
Finland Research Site Oys (oulu)
Finland Research Site Tampere
Finland Research Site Turku
Norway Research Site Bergen
Norway Research Site Bodu
Norway Research Site Drammen
Norway Research Site Fredrikstad
Norway Research Site Harstad
Norway Research Site Kristiansand
Norway Research Site Lesund
Norway Research Site Levanger
Norway Research Site Lillehammer
Norway Research Site Oslo
Norway Research Site Porsgrunn
Norway Research Site RUD
Norway Research Site Stavanger
Norway Research Site Strummen
Norway Research Site Tromsu
Norway Research Site Trondheim
Norway Research Site Tunsberg
Sweden Research Site Goteborg
Sweden Research Site Govle
Sweden Research Site Helsingborg
Sweden Research Site Hudiksvall
Sweden Research Site Junkoping
Sweden Research Site Kristinehamn
Sweden Research Site Luleo
Sweden Research Site Malmu
Sweden Research Site Norrkoping
Sweden Research Site Stockholm
Sweden Research Site Urebro
Sweden Research Site Ustersund
Sweden Research Site VoSTEROS
Sweden Research Site Vostervik

Sponsors (2)
Lead Sponsor Collaborator
AstraZeneca Scandinavian Prostate Cancer Group

Countries where clinical trial is conducted

Denmark,  Finland,  Norway,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival Throughout study period No
Primary Time to clinical progression Throughout study period No
Secondary Tolerability in terms of adverse events and laboratory parameters Throughout study period Yes
Secondary Time to treatment failure Throughout study period No
Secondary Prostate-specific antigen Initial study period up to 2005 amended protocol No
See also
  Status Clinical Trial Phase
Completed NCT04400656 - PROState Pathway Embedded Comparative Trial
Completed NCT00673205 - (Bicalutamide) Casodex vs Placebo in Non-metastatic Early Prostate Cancer Phase 3
Recruiting NCT06202248 - A Study to Assess Alpha DaRT224 for the Treatment of Men With Non-metastatic Locally Recurrent Prostate Cancer N/A
Recruiting NCT01317043 - A Trial of Samarium 153 Followed by Salvage Prostatic Fossa 3D-CRT or IMRT Irradiation in High-Risk, Clinically Non-Metastatic Prostate Cancer After Radical Prostatectomy Phase 2
Completed NCT06204302 - An Observational Study to Learn More About the Use of Androgen Receptor Inhibitors and How They Affect Men With Nonmetastatic Prostate Cancer in Routine Medical Care in the United States
Completed NCT00239291 - Safety Study to Explore Combination of Gefitinib (ZD1839, Iressa) and Radiotherapy in Non-Metastatic Prostate Cancer Phase 1/Phase 2
Recruiting NCT04049747 - Comparative Health Research Outcomes of NOvel Surgery in Prostate Cancer N/A
Active, not recruiting NCT05617885 - Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer Phase 1/Phase 2
Completed NCT00657904 - Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer Phase 3

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