search
Back to results

Effect of Casodex on Tumour Hypoxia - Prostate Cancer

Primary Purpose

Prostatic Neoplasms

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
hypoxia measurement
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostatic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Men with histologically proven prostatic carcinoma, stage cT2, N0, M0, receiving neoadjuvant bicalutamide plus conformal radiotherapy in study 9907, who have previously participated in the prostate cancer hypoxia project informed consent Exclusion Criteria: Coagulopathy

Sites / Locations

  • Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

hypoxia measurement

Arm Description

Patients undergoing or planning to receive combined anti-androgen (Casodex) and radiotherapy

Outcomes

Primary Outcome Measures

To determine the effect of neoadjuvant anti-androgen therapy on oxygenation of prostatic tumours
Trans-rectal ultrasound and measurement of tumor oxygenation
Correlate level of tumor oxygenation with PSA level
PSA test (ug/L)
Correlate level of tumor oxygenation with hemoglobin level
hemoglobin test (g/L)
Correlate level of tumor oxygenation with prostate volume
prostate volume measurement

Secondary Outcome Measures

To study of the effect of neoadjuvant anti-androgen therapy on prostate tumour histopathology and gene expression, and correlation of these effects with changes in oxygenation.

Full Information

First Posted
September 12, 2005
Last Updated
May 7, 2023
Sponsor
University Health Network, Toronto
Collaborators
Canadian Cancer Trials Group, Princess Margaret Hospital, Canada
search

1. Study Identification

Unique Protocol Identification Number
NCT00188708
Brief Title
Effect of Casodex on Tumour Hypoxia - Prostate Cancer
Official Title
A Study of the Effect of Neoadjuvant Bicalutamide (Casodex) on Tumour Hypoxia in Patients With Clinically Localized Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2001 (undefined)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Canadian Cancer Trials Group, Princess Margaret Hospital, Canada

4. Oversight

5. Study Description

Brief Summary
Prostate cancers, in common with many other tumours, are often hypoxic; that is, they have low levels of oxygen. It is thought that tumour hypoxia may hasten the progression of cancers and make them more resistant to treatment. One previous study has suggested that hormone therapy, such as Casodex, may improve the prostate oxygen level. This study is designed to test that finding.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hypoxia measurement
Arm Type
Experimental
Arm Description
Patients undergoing or planning to receive combined anti-androgen (Casodex) and radiotherapy
Intervention Type
Procedure
Intervention Name(s)
hypoxia measurement
Intervention Description
transrectal oxygen measurement
Primary Outcome Measure Information:
Title
To determine the effect of neoadjuvant anti-androgen therapy on oxygenation of prostatic tumours
Description
Trans-rectal ultrasound and measurement of tumor oxygenation
Time Frame
8 weeks
Title
Correlate level of tumor oxygenation with PSA level
Description
PSA test (ug/L)
Time Frame
8 weeks
Title
Correlate level of tumor oxygenation with hemoglobin level
Description
hemoglobin test (g/L)
Time Frame
8 weeks
Title
Correlate level of tumor oxygenation with prostate volume
Description
prostate volume measurement
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
To study of the effect of neoadjuvant anti-androgen therapy on prostate tumour histopathology and gene expression, and correlation of these effects with changes in oxygenation.
Time Frame
8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men with histologically proven prostatic carcinoma, stage cT2, N0, M0, receiving neoadjuvant bicalutamide plus conformal radiotherapy in study 9907, who have previously participated in the prostate cancer hypoxia project informed consent Exclusion Criteria: Coagulopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Milosevic, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Effect of Casodex on Tumour Hypoxia - Prostate Cancer

We'll reach out to this number within 24 hrs