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

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

This study is currently recruiting participants.

Verified by Canadian Urology Research Consortium, January 2009

First Received: November 5, 2007 Last Updated: January 27, 2009 History of Changes

Sponsors and Collaborators:	Canadian Urology Research Consortium AstraZeneca
Information provided by:	Canadian Urology Research Consortium
ClinicalTrials.gov Identifier:	NCT00554086

Purpose

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	Intervention	Phase
Prostate Cancer	Drug: Escalating dose of Casodex from 50mg daily to 150 mg daily	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Bicalutamide

U.S. FDA Resources

Further study details as provided by Canadian Urology Research Consortium:

Primary Outcome Measures:

Doubling of PSA [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	November 2005
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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%

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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 -

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554086

Contacts

Contact: Laurence Klotz, M.D	416 480 4673	laurence.klotz@sunnybrook.ca
Contact: Marlene Kebabdjian, BA	416-480-6100 ext 2890	marlene.kebabdjian@sunnybrook.ca

Locations

Canada, Ontario
Sunnybrook Health Sciences Centre	Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Marlene Kebabdjian, BA 416 480 6100 ext 2890 marlene.kebabdjian@sunnybrook.ca
Contact: Irene McNeill, BScPhm 416 480 6100 ext 2431 irene.mcneill@sunnybrook.ca
Principal Investigator: Lesley Carr, M.D

Sponsors and Collaborators

Canadian Urology Research Consortium

AstraZeneca

Investigators

Principal Investigator:

Laurence Klotz

Canadian Urology Research Consortium

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Canadian Urology Research Consortium ( Dr. Laurence Klotz )
Study ID Numbers:	D6876L00008
Study First Received:	November 5, 2007
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00554086 History of Changes
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Androgen Antagonists
Prostatic Diseases
Genital Neoplasms, Male
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Bicalutamide

Urogenital Neoplasms
Genital Diseases, Male
Hormones
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male

Pharmacologic Actions
Neoplasms
Androgen Antagonists
Neoplasms by Site
Therapeutic Uses
Bicalutamide
Prostatic Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009