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Effect of Casodex on Tumour Hypoxia - Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00188708
First Posted: September 16, 2005
Last Update Posted: March 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Canadian Cancer Trials Group
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
  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: hypoxia measurement Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 [ Time Frame: 8 weeks ]
    Trans-rectal ultrasound and measurement of tumor oxygenation

  • Correlate level of tumor oxygenation with PSA level [ Time Frame: 8 weeks ]
    PSA test (ug/L)

  • Correlate level of tumor oxygenation with hemoglobin level [ Time Frame: 8 weeks ]
    hemoglobin test (g/L)

  • Correlate level of tumor oxygenation with prostate volume [ Time Frame: 8 weeks ]
    prostate volume measurement


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: April 2001
Estimated Study Completion Date: April 2018
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hypoxia measurement
Patients undergoing or planning to receive combined anti-androgen (Casodex) and radiotherapy
Procedure: hypoxia measurement
transrectal oxygen measurement

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188708


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

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00188708     History of Changes
Other Study ID Numbers: UHN REB 00-0430-C
National Cancer Inst of Canada
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: March 24, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Hypoxia
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
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
Antineoplastic Agents