Casodex vs Placebo in Non-Metastatic Early Prostate Cancer - Full Text View

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 III

MedlinePlus related topics:

Cancer Prostate Cancer

Drug Information available for:

Bicalutamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

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

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
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Placebo Comparator	Drug: Placebo
B: Active Comparator	Drug: Bicalutamide 150mg p.o. daily

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

Responsible Party:	AstraZeneca Pharmaceuticals ( Dr Tom Morris )
Study ID Numbers:	D6876C00025, 7054IL/0025
First Received:	May 2, 2008
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00672282
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: National Agency for Medicines; Norway: Data Inspectorate; Norway: Directorate for Health and Social Affairs; 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

Study placed in the following topic categories:

Prostatic Diseases

Genital Neoplasms, Male

Bicalutamide

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Neoplasms

Additional relevant MeSH terms:

Androgen Antagonists

Neoplasms

Neoplasms by Site

Antineoplastic Agents

Therapeutic Uses

Hormone Antagonists

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 24, 2008

Sponsors and Collaborators:	AstraZeneca Scandinavian Prostate Cancer Group
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00672282