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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00672282
Recruitment Status : Completed
First Posted : May 6, 2008
Last Update Posted : May 27, 2009
Scandinavian Prostate Cancer Group
Information provided by:

Brief 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.

Condition or disease Intervention/treatment Phase
Non-Metastatic Prostate Cancer Drug: Bicalutamide Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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.
Study Start Date : October 1995
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Placebo Comparator: A Drug: Placebo
Active Comparator: B Drug: Bicalutamide
150mg p.o. daily
Other Name: Casodex

Primary Outcome Measures :
  1. Survival [ Time Frame: Throughout study period ]
  2. Time to clinical progression [ Time Frame: Throughout study period ]

Secondary Outcome Measures :
  1. Tolerability in terms of adverse events and laboratory parameters [ Time Frame: Throughout study period ]
  2. Time to treatment failure [ Time Frame: Throughout study period ]
  3. Prostate-specific antigen [ Time Frame: Initial study period up to 2005 amended protocol ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00672282

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Sponsors and Collaborators
Scandinavian Prostate Cancer Group
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Principal Investigator: Peter Iversen, MD Department of Urology Rigshospitalet Copenhagen Denmark
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr Tom Morris, AstraZeneca Pharmaceuticals Identifier: NCT00672282    
Other Study ID Numbers: D6876C00025
First Posted: May 6, 2008    Key Record Dates
Last Update Posted: May 27, 2009
Last Verified: March 2009
Keywords provided by AstraZeneca:
androgen antagonists
prostate neoplasms
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents