- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00160979
Transrectal Tumour Oxygen - US Army
A Study of Transrectal Tumour Oxygen Measurements in Patients With Clinically Localized Prostate Cancer
Prostate cancer is now the most commonly diagnosed tumor among men in the United States. Most patients have tumors that are confined to the prostate gland at diagnosis and are suitable for treatment with surgery or radiotherapy (RT) that is aimed at curing the disease. Nevertheless, despite recent improvements in these treatments, a large number of men continue to die of prostate cancer. These patients often have spread of tumor to other areas of the body, and are treated with hormones that produce initial tumor shrinkage. However, over time the tumor learns to grow despite continued hormonal treatment. Effective therapy for patients with hormone-resistant prostate cancer is lacking and patients often deteriorate quickly and die. Thus, there is a need for better treatment that cures prostate cancer at an early stage, and a better understanding of the biology of prostate cancer specifically with respect to factors that determine the effectiveness of RT, the spread of tumor and the development of hormone-resistant disease.
Low levels of oxygen (hypoxia) are known to exist in many human tumors, and studies have shown that hypoxic tumors are less likely to be cured by RT. In addition, hypoxia may lead to lower cure rates following surgery, spread of cancer to other areas of the body, and changes in the genetic characteristics of the cancer cells that cause them to behave more aggressively.
The importance of hypoxia in prostate cancer has not previously been evaluated. The aims of this study are to determine how often hypoxia occurs in early prostate cancer and whether hypoxia influences the success of RT, tumor spread beyond the prostate to bones and other organs and the development of hormone-resistant disease. Patients will have tumor oxygen levels measured using a special fine-needle electrode system prior to beginning treatment with either RT or the combination of hormones plus RT. The measurements will be made through the rectum using ultrasound to position and guide the electrode. A biopsy of the tumor will be obtained at the site of the measurements, and this will be used to determine how oxygen influences changes in the genetic character of prostate cancer cells. A total of 195 patients will be evaluated in this way over 3 years.
This study will provide unique information about the behavior of prostate cancer, which may help explain why currently available treatments including surgery, RT and hormones fail to cure patients. Assuming that this study shows hypoxia to be important in prostate cancer, future work will focus on new anti-hypoxia treatments to be used in combination with surgery or RT with the aim of overcoming this obstacle and improving cure rates.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: hypoxia and RT in prostate cancer
|
Pre-treatment tumour oxygen measurements
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: after follow-up is completed
|
after follow-up is completed
|
To determine the relationship between pre-treatment tumor oxygen levels and mutations of the p53 gene, and the impact of this interaction on patient outcome.
Time Frame: after follow up is completed
|
after follow up is completed
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate oxygen levels in clinically localized prostate cancer prior to treatment.
Time Frame: after follow-up is completed
|
after follow-up is completed
|
To determine the relationship between pre-treatment tumor oxygen levels and the subsequent development of metastases and androgen-resistant prostate cancer.
Time Frame: after follow is completed
|
after follow is completed
|
To determine whether androgen ablation overcomes any adverse effect of hypoxia on outcome.
Time Frame: after follow up is completed
|
after follow up is completed
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michael Milosevic, MD, Princess Margaret Hospital, Canada
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHN REB 00-0443-C
- US Army DAMD17-01-1-0111
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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