Effect of Casodex on Tumour Hypoxia - Prostate Cancer
A Study of the Effect of Neoadjuvant Bicalutamide (Casodex) on Tumour Hypoxia in Patients With Clinically Localized Prostate Cancer
2 other identifiers
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2001
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2022
CompletedMarch 18, 2024
March 1, 2024
21 years
September 12, 2005
March 15, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
To determine the effect of neoadjuvant anti-androgen therapy on oxygenation of prostatic tumours
Trans-rectal ultrasound and measurement of tumor oxygenation
8 weeks
Correlate level of tumor oxygenation with PSA level
PSA test (ug/L)
8 weeks
Correlate level of tumor oxygenation with hemoglobin level
hemoglobin test (g/L)
8 weeks
Correlate level of tumor oxygenation with prostate volume
prostate volume measurement
8 weeks
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.
8 weeks
Study Arms (1)
hypoxia measurement
EXPERIMENTALPatients undergoing or planning to receive combined anti-androgen (Casodex) and radiotherapy
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Coagulopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Health Network, Torontolead
- Canadian Cancer Trials Groupcollaborator
- Princess Margaret Hospital, Canadacollaborator
Study Sites (1)
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Milosevic, MD
Princess Margaret Hospital, Canada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 16, 2005
Study Start
April 1, 2001
Primary Completion
March 10, 2022
Study Completion
March 10, 2022
Last Updated
March 18, 2024
Record last verified: 2024-03