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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

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

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

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.

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

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 -

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Doubling of PSA

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Laurence Klotz

Investigator Role:

Principal Investigator

Investigator Affiliation:

Canadian Urology Research Consortium


Canada: Health Canada

Study ID:




Start Date:

November 2005

Completion Date:

September 2010

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms