Effect of Casodex on Tumour Hypoxia - Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Canadian Cancer Trials Group
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188708
First received: September 12, 2005
Last updated: June 21, 2016
Last verified: June 2016
  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: 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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Trans-rectal ultrasound and measurement of tumor oxygenation

  • Correlate level of tumor oxygenation with PSA level [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    PSA test (ug/L)

  • Correlate level of tumor oxygenation with hemoglobin level [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    hemoglobin test (g/L)

  • Correlate level of tumor oxygenation with prostate volume [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2001
Estimated Study Completion Date: April 2017
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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 
Study First Received: September 12, 2005
Last Updated: June 21, 2016
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bicalutamide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 21, 2016