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

NCT00554086 | Completed Phase 2

• 1 other identifier: D6876L00008
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Doubling of PSA

  one year

Interventions

Escalating dose of Casodex from 50mg daily to 150 mg daily DRUG

Casodex dosage increase from 50mg to 150mg daily until baseline serum PSA is reduced by 50%

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Canadian Urology Research Consortium: lead
• AstraZeneca: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Links

• Related Info

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Laurence Klotz

  Canadian Urology Research Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 5, 2007
• First Posted: November 6, 2007
• Study Start: November 1, 2005
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2010
• Last Updated: May 16, 2011

Record last verified: 2011-05

Locations

CA (1)