Overview

This trial is active, not recruiting.

Condition prostatic neoplasms
Treatment hypoxia measurement
Phase phase 2
Sponsor University Health Network, Toronto
Collaborator Canadian Cancer Trials Group
Start date April 2001
End date April 2008
Trial size 30 participants
Trial identifier NCT00188708, National Cancer Inst of Canada, UHN REB 00-0430-C

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Patients undergoing or planning to receive combined anti-androgen (Casodex) and radiotherapy
hypoxia measurement
transrectal oxygen measurement

Primary Outcomes

Measure
To determine the effect of neoadjuvant anti-androgen therapy on oxygenation of prostatic tumours
time frame: 8 weeks
Correlate level of tumor oxygenation with PSA level
time frame: 8 weeks
Correlate level of tumor oxygenation with hemoglobin level
time frame: 8 weeks
Correlate level of tumor oxygenation with prostate volume
time frame: 8 weeks

Secondary Outcomes

Measure
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

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title A Study of the Effect of Neoadjuvant Bicalutamide (Casodex) on Tumour Hypoxia in Patients With Clinically Localized Prostate Cancer
Principal investigator Michael Milosevic, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.