(Bicalutamide) Casodex vs Placebo in Non-metastatic Early Prostate Cancer (Capri)
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ClinicalTrials.gov Identifier: NCT00673205 |
Recruitment Status
:
Completed
First Posted
: May 7, 2008
Last Update Posted
: December 10, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-Metastatic Prostate Cancer | Drug: Bicalutamide Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3588 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 Bicalutamide (Casodex) 150mg Once Daily With Placebo in Patients With Non-metastatic Prostate Cancer |
Study Start Date : | September 1995 |
Actual Primary Completion Date : | August 2008 |
Actual Study Completion Date : | August 2008 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: A | Drug: Placebo |
Active Comparator: B |
Drug: Bicalutamide
150mg p.o. daily
Other Name: Casodex
|
- Time to clinical progression [ Time Frame: Throughout study period ]
- Tolerability in terms of adverse events and laboratory parameters [ Time Frame: Throughout study period ]
- Survival [ 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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.

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 ClinicalTrials.gov identifier (NCT number): NCT00673205

Principal Investigator: | Manfred P Wirth, Professor | Technical University of Dresden, Germany |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Dr. Tom Morris, AstraZeneca Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00673205 History of Changes |
Other Study ID Numbers: |
D6876C00024 7054IL/0024 |
First Posted: | May 7, 2008 Key Record Dates |
Last Update Posted: | December 10, 2010 |
Last Verified: | December 2010 |
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 |