Prostatic Neoplasms
Conditions
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.
Interventions
PROCEDUREhypoxia measurement
transrectal oxygen measurement
Sponsors
Canadian Cancer Trials Group
Princess Margaret Hospital, Canada
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada
Outcome results
None listed