Effect of Casodex on Tumour Hypoxia - Prostate Cancer

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00188708
• Other study ID #: UHN REB 00-0430-C
• Secondary ID: National Cancer
• Status: Completed
• Phase: N/A
• Start date: April 2001
• Est. completion date: March 10, 2022

Study information

• Verified date: March 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 10, 2022
• Est. primary completion date: March 10, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoxia
• Prostatic Neoplasms

Intervention

Procedure:
• hypoxia measurement
transrectal oxygen measurement

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian Cancer Trials Group, Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the effect of neoadjuvant anti-androgen therapy on oxygenation of prostatic tumours	Trans-rectal ultrasound and measurement of tumor oxygenation	8 weeks
Primary	Correlate level of tumor oxygenation with PSA level	PSA test (ug/L)	8 weeks
Primary	Correlate level of tumor oxygenation with hemoglobin level	hemoglobin test (g/L)	8 weeks
Primary	Correlate level of tumor oxygenation with prostate volume	prostate volume measurement	8 weeks
Secondary	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.		8 weeks