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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00554086
First Posted: November 6, 2007
Last Update Posted: May 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by:
Canadian Urology Research Consortium
November 5, 2007
November 6, 2007
May 16, 2011
November 2005
September 2009   (Final data collection date for primary outcome measure)
Doubling of PSA [ Time Frame: one year ]
Same as current
Complete list of historical versions of study NCT00554086 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Open Label,Phase II Trial of MAB Dose Escalation OF Bicalutamide For Biochemical Failure In Prostate Cancer Patients.
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.
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.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
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%
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
September 2010
September 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Provision of written informed consent.
  2. Men, over 18 years of age, with histologically-confirmed prostate cancer
  3. Treatment with Zoladex (goserelin acetate) for greater than 3 months prior to Day 1
  4. Serum testosterone level < 50 ng/ml
  5. Current treatment with bicalutamide 50 mg daily.**
  6. Two consecutive rises in PSA above a nadir value, with the absolute value of the latest PSA > 2.0 ng/ml.
  7. Highest PSA level no greater than or equal to 30 ng/ml.
  8. Life expectancy of greater than 1 year -

Exclusion Criteria:

  1. 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.*
  2. PSA level greater than 30 ng/ml.
  3. 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.
  4. Subjects who have received prior chemotherapy.
  5. 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.
  6. Absolute neutrophil count less than 1.5 x 109/L or platelets less than 100 x 109/L.
  7. Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR).
  8. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULRR.
  9. Serum creatinine greater than 1.5 times -
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00554086
D6876L00008
No
Not Provided
Not Provided
Dr. Laurence Klotz, Canadian Urology Research Consortium
Canadian Urology Research Consortium
AstraZeneca
Principal Investigator: Laurence Klotz Canadian Urology Research Consortium
Canadian Urology Research Consortium
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP