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Open Label,Phase II Trial of MAB Dose Escalation OF Bicalutamide For Biochemical Failure In Prostate Cancer Patients.

NCT00554086 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2011-05-16

No results posted yet for this study

Summary

Multi-centre one year trial for patients who have rising PSA while on Casodex 50mg daily dose. Casodex dosage escalated to 150 mg tablet daily. Treatment will be continued until patient demonstrates clinical benefit at one year, PSA progression, toxicity, or withdrawal. Treatment will be continued after one year if patient demonstrates continued clinical benefit.

Conditions

Interventions

DRUG

Escalating dose of Casodex from 50mg daily to 150 mg daily

Casodex dosage increase from 50mg to 150mg daily until baseline serum PSA is reduced by 50%

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Canadian Urology Research Consortium

    lead OTHER

Principal Investigators

  • Laurence Klotz · Canadian Urology Research Consortium

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2009-09-30
Completion
2010-09-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00554086 on ClinicalTrials.gov