NCT00846976

Brief Summary

This is an open label, single-centered treatment protocol designed to monitor the safety of patients treated with a 200 mg daily dose of CASODEX. Patient will receive CASODEX as long as physician feels that he is benefiting from this form of therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at below P25 for phase_3 prostate-cancer

Timeline
Completed

Started Dec 1994

Longer than P75 for phase_3 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1994

Completed
14.2 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

18.5 years

First QC Date

February 18, 2009

Last Update Submit

January 20, 2015

Conditions

Prostate Cancer

Keywords

Safety

Outcome Measures

Primary Outcomes (1)

  • Safety profile of patients treated with a 200 mg daily dose of CASODEX

    every three months

Study Arms (1)

200 mg Casodex

EXPERIMENTAL
Drug: Bicalutamide

Interventions

BicalutamideDRUG

200mg daily

Also known as: Casodex
200 mg Casodex

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate gland
  • Patients with advanced prostate cancer
  • Adult male over the age of 18 years old
  • Normal liver function (AST \< 2 x Upper Limit Normal)

You may not qualify if:

  • ECOG performance status of 4.
  • Previous history or presence of another malignancy other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last 5 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

New York, New York, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2009

First Posted

February 19, 2009

Study Start

December 1, 1994

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

January 21, 2015

Record last verified: 2015-01

Locations

US(1)