Trial Information
A Study of Transrectal Tumour Oxygen Measurements in Patients With Clinically Localized Prostate Cancer
Inclusion Criteria:
- A histologic diagnosis of adenocarcinoma of the prostate
- A decision to treat using high-dose conformal radiotherapy, with or without
neoadjuvant and concurrent androgen ablation
- Clinical stage T2a or T2b, N0, M0 (UICC 1997 68)
- No hormonal or cytotoxic anti-cancer therapy prior to study entry
- ECOG performance status of 2 or less
- Ability to understand the English language
- Signed informed consent
Exclusion Criteria:
- Patients with prior or active malignancy within 5 years of the diagnosis of prostate
cancer, except non-melanoma skin cancer
Type of Study:
Interventional
Study Design:
Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
To determine the relationship between pre-treatment prostate cancer oxygen levels and long-term disease control following treatment with radiotherapy, and the independent prognostic effect of oxygen measurements.
Outcome Time Frame:
after follow-up is completed
Safety Issue:
No
Principal Investigator
Michael Milosevic, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Princess Margaret Hospital, Canada
Authority:
Canada: Ethics Review Committee
Study ID:
UHN REB 00-0443-C
NCT ID:
NCT00160979
Start Date:
January 2001
Completion Date:
January 2014
Related Keywords:
- Prostatic Neoplasms
- Neoplasms
- Prostatic Neoplasms