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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
  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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Survival [ Time Frame: Throughout study period ]
  • Time to clinical progression [ Time Frame: Throughout study period ]

Secondary Outcome Measures:
  • 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 ]

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   (Adult, Senior)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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
Bicalutamide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 25, 2017