Effect of Casodex on Tumour Hypoxia - Prostate Cancer

This study has been completed.
Sponsor:
Collaborators:
NCIC Clinical Trials Group
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188708
First received: September 12, 2005
Last updated: July 10, 2009
Last verified: January 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Study of the Effect of Neoadjuvant Bicalutamide (Casodex) on Tumour Hypoxia in Patients With Clinically Localized Prostate Cancer

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
NCIC Clinical Trials Group
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Michael Milosevic, MD Princess Margaret Hospital, Canada
  More Information

No publications provided

Responsible Party: Dr. Michael Milosevic, Principal Investigator, University Health Network
ClinicalTrials.gov Identifier: NCT00188708     History of Changes
Other Study ID Numbers: UHN REB 00-0430-C, National Cancer Inst of Canada
Study First Received: September 12, 2005
Last Updated: July 10, 2009
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Anoxia
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Bicalutamide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014