- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00554086
Open Label,Phase II Trial of MAB Dose Escalation OF Bicalutamide For Biochemical Failure In Prostate Cancer Patients. (CHICS)
May 13, 2011 updated by: Canadian Urology Research Consortium
Phase 2 Trial of Maximum Androgen Blockade (MAB) Dose Escalation From 50 mg to 150 mg Bicalutamide (Casodex) for Biochemical Failure in Prostate Cancer Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study will be a national, multicentre, open-label, phase II trial.
Patients who have a rising PSA on MAB with bicalutamide 50 mg daily will be dose escalated to MAB with 150 mg bicalutamide daily.
Subjects will receive trial treatment for 12 months, or until disease progression, unacceptable toxicity or withdrawal of consent.
Open label treatment will be offered thereafter if the subject demonstrates clinical benefit at the end of one year.
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Provision of written informed consent.
- Men, over 18 years of age, with histologically-confirmed prostate cancer
- Treatment with Zoladex (goserelin acetate) for greater than 3 months prior to Day 1
- Serum testosterone level < 50 ng/ml
- Current treatment with bicalutamide 50 mg daily.**
- Two consecutive rises in PSA above a nadir value, with the absolute value of the latest PSA > 2.0 ng/ml.
- Highest PSA level no greater than or equal to 30 ng/ml.
- Life expectancy of greater than 1 year -
Exclusion Criteria:
- Patients may not have received prolonged anti-androgen therapy other than with bicalutamide. Patients who have received short term (2 months or less) non-steroidal anti-androgen therapy with an agent other than bicalutamide to block flare are not excluded.*
- PSA level greater than 30 ng/ml.
- In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease which would make it undesirable for the patient to participate in the trial.
- Subjects who have received prior chemotherapy.
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or superficial transitional cell carcinoma of the bladder.
- Absolute neutrophil count less than 1.5 x 109/L or platelets less than 100 x 109/L.
- Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR).
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULRR.
- Serum creatinine greater than 1.5 times -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Doubling of PSA
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Laurence Klotz, Canadian Urology Research Consortium
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (ACTUAL)
September 1, 2009
Study Completion (ACTUAL)
September 1, 2010
Study Registration Dates
First Submitted
November 5, 2007
First Submitted That Met QC Criteria
November 5, 2007
First Posted (ESTIMATE)
November 6, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
May 16, 2011
Last Update Submitted That Met QC Criteria
May 13, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D6876L00008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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