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Antiandrogen

Treatment Protocol to Monitor the Safety of a 200 mg Dose of Bicalutamide in Patients With Advanced Prostate Cancer

Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

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.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2016 Phase 3 trial • 116 Patients • NCT02085252
29%
Hot flush
16%
Flushing
12%
Erectile dysfunction
10%
Libido decreased
7%
Fatigue
7%
Dysuria
5%
Headache
5%
Bronchitis
3%
Back pain
2%
Atrial flutter
2%
Dizziness
2%
Hypertension
2%
Deafness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Leuprorelin 11.25 mg
Active Surveillance

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 200 mg CasodexExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bicalutamide
FDA approved

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,427 Previous Clinical Trials
289,164,498 Total Patients Enrolled
56 Trials studying Prostate Cancer
25,231 Patients Enrolled for Prostate Cancer
~3 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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