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

Prostate Cancer Clinical Trial

— CHICS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554086
• Other study ID #: D6876L00008
• Status: Completed
• Phase: Phase 2
• First received: November 5, 2007
• Last updated: May 13, 2011
• Start date: November 2005
• Est. completion date: September 2010

Study information

• Verified date: May 2011
• Source: Canadian Urology Research Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00260455

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 -

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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%

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Canadian Urology Research Consortium	AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Doubling of PSA		one year	No

External Links

•   Link