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:
Collaborator:
AstraZeneca
Information provided by:
Canadian Urology Research Consortium
ClinicalTrials.gov Identifier:
NCT00554086
First received: November 5, 2007
Last updated: May 13, 2011
Last verified: May 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ]

Enrollment: 65
Study Start Date: November 2005
Study Completion Date: September 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
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%
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:

  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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

Responsible Party: Dr. Laurence Klotz, Canadian Urology Research Consortium
ClinicalTrials.gov Identifier: NCT00554086     History of Changes
Obsolete Identifiers: NCT00260455
Other Study ID Numbers: D6876L00008
Study First Received: November 5, 2007
Last Updated: May 13, 2011
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on October 01, 2014