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Completed

NCT Number: NCT00188708

Effect of Casodex on Tumour Hypoxia - Prostate Cancer

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.

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hypoxia measurement

Procedure

transrectal oxygen measurement

Primary outcomes

  1. 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

  2. Correlate level of tumor oxygenation with PSA level

    Time frame: 8 weeks

    PSA test (ug/L)

  3. Correlate level of tumor oxygenation with hemoglobin level

    Time frame: 8 weeks

    hemoglobin test (g/L)

  4. Correlate level of tumor oxygenation with prostate volume

    Time frame: 8 weeks

    prostate volume measurement

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Canadian Cancer Trials Group
  • Princess Margaret Hospital, Canada

Registry information

Official study title

A Study of the Effect of Neoadjuvant Bicalutamide (Casodex) on Tumour Hypoxia in Patients With Clinically Localized Prostate Cancer

Important dates

Study start
2001
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2005
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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