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

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. Identifier: NCT00554086
Recruitment Status : Completed
First Posted : November 6, 2007
Last Update Posted : May 16, 2011
Information provided by:
Canadian Urology Research Consortium

Brief 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Escalating dose of Casodex from 50mg daily to 150 mg daily Phase 2

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  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2005
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Intervention Details:
  • 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%

Primary Outcome Measures :
  1. Doubling of PSA [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00554086

Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Canadian Urology Research Consortium
Principal Investigator: Laurence Klotz Canadian Urology Research Consortium

Additional Information:
Responsible Party: Dr. Laurence Klotz, Canadian Urology Research Consortium Identifier: NCT00554086     History of Changes
Obsolete Identifiers: NCT00260455
Other Study ID Numbers: D6876L00008
First Posted: November 6, 2007    Key Record Dates
Last Update Posted: May 16, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents