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Casodex vs Placebo in Non-Metastatic Early Prostate Cancer (SPCG6)

This study has been completed.
Sponsor:
Collaborator:
Scandinavian Prostate Cancer Group
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00672282
First received: May 2, 2008
Last updated: May 26, 2009
Last verified: March 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Non-Metastatic Prostate Cancer
 Drug: Bicalutamide
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group Trial Comparing Casodex 150mg Once Daily With Placebo in Patients With Non-Metastatic Prostate Cancer.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Survival [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]
  • Time to clinical progression [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability in terms of adverse events and laboratory parameters [ Time Frame: Throughout study period ] [ Designated as safety issue: Yes ]
  • Time to treatment failure [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]
  • Prostate-specific antigen [ Time Frame: Initial study period up to 2005 amended protocol ] [ Designated as safety issue: No ]

Enrollment: 1218
Study Start Date: October 1995
Study Completion Date: August 2008
Arms Assigned Interventions
Placebo Comparator: A Drug: Placebo
Active Comparator: B Drug: Bicalutamide
150mg p.o. daily
Other Name: Casodex

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00672282

  Show 54 Study Locations
Sponsors and Collaborators
AstraZeneca
Scandinavian Prostate Cancer Group
Investigators
Principal Investigator: Peter Iversen, MD Department of Urology Rigshospitalet Copenhagen, Denmark
  More Information

Additional Information:
US and Canada only  This link exits the ClinicalTrials.gov site

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr Tom Morris, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00672282     History of Changes
Other Study ID Numbers: D6876C00025, 7054IL/0025
Study First Received: May 2, 2008
Last Updated: May 26, 2009
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: National Board of Health
Denmark: The Ministry of the Interior and Health
Finland: Ministry of Social Affairs and Health
Finland: Finnish Medicines Agency
Norway: Data Protection Authority
Norway: Directorate of Health
Norway: Norwegian Institute of Public Health
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
Sweden: Swedish National Council on Medical Ethics
Sweden: The National Board of Health and Welfare

Keywords provided by AstraZeneca:
androgen antagonists
prostate neoplasms

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgen Antagonists
 Bicalutamide
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013