Effect of Casodex on Tumour Hypoxia - Prostate Cancer

This study is currently recruiting participants.

Verified by University Health Network, Toronto, September 2005

First Received: September 12, 2005 No Changes Posted

Sponsors and Collaborators:	University Health Network, Toronto National Cancer Institute of Canada Princess Margaret Hospital, Canada
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00188708

Purpose

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	Intervention	Phase
Prostatic Neoplasms	Procedure: tumour oxygen measurements post treatment (Casodex)	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Bicalutamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Study of the Effect of Neoadjuvant Bicalutamide (Casodex) on Tumour Hypoxia in Patients With Clinically Localized Prostate Cancer

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

To determine the effect of neoadjuvant anti-androgen therapy on oxygenation of prostatic tumours, and to correlate with changes in PSA, hemoglobin level, and prostate volume.

Secondary Outcome Measures:

To enable 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.

Estimated Enrollment:	30
Study Start Date:	April 2001

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188708

Contacts

Contact: Michael Milosevic, MD

416-946-21254

michael.milosevic@rmp.uhn.on.ca

Locations

Canada, Ontario
Princess Margaret Hospital	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Michael Milosevic, MD 416-946-2124 michael.milosevic@rmp.uhn.on.ca

Sponsors and Collaborators

University Health Network, Toronto

National Cancer Institute of Canada

Princess Margaret Hospital, Canada

Investigators

Principal Investigator:

Michael Milosevic, MD

Princess Margaret Hospital, Canada

More Information

No publications provided

Study ID Numbers:	UHN REB 00-0430-C, National Cancer Inst of Canada
Study First Received:	September 12, 2005
Last Updated:	September 12, 2005
ClinicalTrials.gov Identifier:	NCT00188708 History of Changes
Health Authority:	Canada: Ethics Review Committee

Study placed in the following topic categories:

Androgen Antagonists
Prostatic Diseases
Genital Neoplasms, Male
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Bicalutamide

Urogenital Neoplasms
Genital Diseases, Male
Hormones
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male

Pharmacologic Actions
Neoplasms
Androgen Antagonists
Neoplasms by Site
Therapeutic Uses
Bicalutamide
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009