Effect of Casodex on Tumour Hypoxia - Prostate Cancer

University Health Network, Toronto30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Prostatic Neoplasms

Interventions

hypoxia measurementPROCEDURE

transrectal oxygen measurement

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Princess Margaret Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

To determine the effect of neoadjuvant anti-androgen therapy on oxygenation of prostatic tumours

Trans-rectal ultrasound and measurement of tumor oxygenation

Time frame: 8 weeks

Correlate level of tumor oxygenation with PSA level

PSA test (ug/L)

Time frame: 8 weeks

Correlate level of tumor oxygenation with hemoglobin level

hemoglobin test (g/L)

Time frame: 8 weeks

Correlate level of tumor oxygenation with prostate volume

prostate volume measurement

Time frame: 8 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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