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Tumor Oxygen Level Measurement for Prostate Cancer
Phase 2
Waitlist Available
Led By Michael Milosevic, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status of 2 or less
Clinical stage T2a or T2b, N0, M0 (UICC 1997 68)
Must not have
Patients with prior or active malignancy within 5 years of the diagnosis of prostate cancer, except non-melanoma skin cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after follow up is completed
Awards & highlights
Summary
This trial is testing whether low levels of oxygen in the tumor (hypoxia) play a role in prostate cancer.
Who is the study for?
Men with early-stage prostate cancer (specifically stage T2a or T2b, N0, M0) who haven't had hormone or anti-cancer therapy and can perform daily activities with minimal assistance. They must understand English and consent to the study. Those with other cancers within the last 5 years, except non-melanoma skin cancer, are excluded.Check my eligibility
What is being tested?
The trial is measuring oxygen levels in prostate tumors using a needle electrode guided by ultrasound through the rectum before starting high-dose radiotherapy alone or combined with hormone treatment. It aims to see if low oxygen affects treatment success and tumor behavior.See study design
What are the potential side effects?
Potential side effects include discomfort from the fine-needle electrode procedure for measuring tumor oxygen levels and standard risks associated with biopsies such as bleeding or infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but cannot do heavy physical work.
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My cancer is in stage T2a or T2b, has not spread to lymph nodes or other parts of the body.
Select...
My prostate cancer is adenocarcinoma.
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I am set to receive high-dose radiation therapy for my condition, possibly with hormone therapy.
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I have not had hormone or chemotherapy before joining this study.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had cancer, other than non-melanoma skin cancer, in the last 5 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after follow-up is completed
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after follow-up is completed
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
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.
Secondary outcome measures
To determine the relationship between pre-treatment tumor oxygen levels and the subsequent development of metastases and androgen-resistant prostate cancer.
To determine whether androgen ablation overcomes any adverse effect of hypoxia on outcome.
To evaluate oxygen levels in clinically localized prostate cancer prior to treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: hypoxia and RT in prostate cancerExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
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489,849 Total Patients Enrolled
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245,834 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had cancer, other than non-melanoma skin cancer, in the last 5 years.I can take care of myself but cannot do heavy physical work.I am set to receive high-dose radiation therapy for my condition, possibly with hormone therapy.My cancer is in stage T2a or T2b, has not spread to lymph nodes or other parts of the body.My prostate cancer is adenocarcinoma.I am set to receive high-dose radiation therapy for my condition, possibly with hormone therapy.I have been diagnosed with prostate adenocarcinoma.I have not had hormone or chemotherapy before joining this study.
Research Study Groups:
This trial has the following groups:- Group 1: hypoxia and RT in prostate cancer
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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