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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 below
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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.
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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:
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I have not had cancer, other than non-melanoma skin cancer, in the last 5 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after follow-up is completed
This trial's timeline: 3 weeks for screening, Varies for treatment, and after follow-up is completed for reporting.

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
1,492 Previous Clinical Trials
489,849 Total Patients Enrolled
65 Trials studying Prostate Cancer
15,500 Patients Enrolled for Prostate Cancer
Princess Margaret Hospital, CanadaOTHER
119 Previous Clinical Trials
38,864 Total Patients Enrolled
10 Trials studying Prostate Cancer
9,916 Patients Enrolled for Prostate Cancer
U.S. Army Medical Research and Development CommandFED
288 Previous Clinical Trials
245,834 Total Patients Enrolled

Media Library

Pre-treatment tumour oxygen measurements (Other) Clinical Trial Eligibility Overview. Trial Name: NCT00160979 — Phase 2
Prostate Cancer Research Study Groups: hypoxia and RT in prostate cancer
Prostate Cancer Clinical Trial 2023: Pre-treatment tumour oxygen measurements Highlights & Side Effects. Trial Name: NCT00160979 — Phase 2
Pre-treatment tumour oxygen measurements (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00160979 — Phase 2
~25 spots leftby Jan 2028