Effect of Casodex on Tumour Hypoxia - Prostate Cancer

NCT ID: NCT00188708

Last Updated: 2024-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2022-03-10

Brief Summary

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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.

Detailed Description

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Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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hypoxia measurement

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

Group Type EXPERIMENTAL

hypoxia measurement

Intervention Type PROCEDURE

transrectal oxygen measurement

Interventions

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hypoxia measurement

transrectal oxygen measurement

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Canadian Cancer Trials Group

NETWORK

Sponsor Role collaborator

Princess Margaret Hospital, Canada

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Milosevic, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Locations

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Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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National Cancer Inst of Canada

Identifier Type: -

Identifier Source: secondary_id

UHN REB 00-0430-C

Identifier Type: -

Identifier Source: org_study_id

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