Effect of Casodex on Tumour Hypoxia - Prostate Cancer

Sponsor

University Health Network, Toronto (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00188708

Collaborator

Canadian Cancer Trials Group (Other), Princess Margaret Hospital, Canada (Other)

Enrollment

Location

Arm

252

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms	Procedure: hypoxia measurement	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

A Study of the Effect of Neoadjuvant Bicalutamide (Casodex) on Tumour Hypoxia in Patients With Clinically Localized Prostate Cancer

Study Start Date :

Apr 1, 2001

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Apr 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: hypoxia measurement Patients undergoing or planning to receive combined anti-androgen (Casodex) and radiotherapy	Procedure: hypoxia measurement transrectal oxygen measurement

Arm

Intervention/Treatment

Experimental: hypoxia measurement

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

Procedure: hypoxia measurement

transrectal oxygen measurement

Outcome Measures

Primary Outcome Measures

To determine the effect of neoadjuvant anti-androgen therapy on oxygenation of prostatic tumours [8 weeks]
Trans-rectal ultrasound and measurement of tumor oxygenation
Correlate level of tumor oxygenation with PSA level [8 weeks]
PSA test (ug/L)
Correlate level of tumor oxygenation with hemoglobin level [8 weeks]
hemoglobin test (g/L)
Correlate level of tumor oxygenation with prostate volume [8 weeks]
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. [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

University Health Network, Toronto
Canadian Cancer Trials Group
Princess Margaret Hospital, Canada

Investigators

Principal Investigator: Michael Milosevic, MD, Princess Margaret Hospital, Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT00188708

Other Study ID Numbers:

UHN REB 00-0430-C
National Cancer Inst of Canada

First Posted:

Sep 16, 2005

Last Update Posted:

Oct 5, 2021

Last Verified:

Oct 1, 2021

Additional relevant MeSH terms:

Prostatic Neoplasms

Hypoxia

Study Results

No Results Posted as of Oct 5, 2021