NCT00554086

CompletedPhase 2

Open Label,Phase II Trial of MAB Dose Escalation OF Bicaluta...

Canadian Urology Research Consortium Source

Canadian Urology Research Consortium

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

D6876L00008

Study Type

interventional

Actual enrollment (reported)

65

Locations

1 country

Sites

1

Timeline

Study Start

November 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2009

Actual (reported)

Study Completion

September 2010

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 65 participants
Study completion date: September 2010
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
November 5, 2007
Actual (reported)
First Posted
November 6, 2007
Actual (reported)
Primary Completion
September 2009
Actual (reported)
Study Completion
September 2010
Actual (reported)

Last Updated: May 16, 2011
Status Verified: May 2011
Last Update Submitted: May 13, 2011

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

Doubling of PSA
one year

Interventions

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

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Canadian Urology Research Consortium
Otherlead
AstraZeneca
Industrycollaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

Laurence Klotz
Canadian Urology Research Consortium
PRINCIPAL INVESTIGATOR

Enrollment

65 participants (actual enrollment reported by the registry).

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 2005

Date type not reported

This date has not been verified as actual or estimated.

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Phase 2Terminated

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Phase 2Completed

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NCT00757692

Efficacy and Safety Study of Vandetanib (ZD 6474) in Combination With Bicalutamide Versus Bicalutamide Alone in Patients With Chemotherapy Naive Hormone Refractory Prostate Cancer.

Phase 2Completed

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 -

Contact the study team to confirm eligibility.

Primary Completion

September 2009

Actual (reported)

Study Completion

September 2010

Actual (reported)

Last Updated

May 16, 2011

Record last verified: 2011-05

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00554086
Data provider: ClinicalTrials.gov
Source updated: 2011-05-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:30:58 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations