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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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after follow up is completed
Awards & highlights
No Placebo-Only Group

Study 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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My prostate cancer is classified as 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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My cancer is in stage T2a or T2b, has not spread to lymph nodes or other parts of the body.
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I have not had hormone or chemotherapy before joining this study.
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I can take care of myself but cannot do heavy physical work.

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.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active 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
1,449 Previous Clinical Trials
483,013 Total Patients Enrolled
63 Trials studying Prostate Cancer
15,372 Patients Enrolled for Prostate Cancer
Princess Margaret Hospital, CanadaOTHER
118 Previous Clinical Trials
38,495 Total Patients Enrolled
9 Trials studying Prostate Cancer
9,540 Patients Enrolled for Prostate Cancer
U.S. Army Medical Research and Development CommandFED
285 Previous Clinical Trials
244,975 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this experiment still open?

"As per clinicaltrials.gov, this medical trial is not presently enrolling patients. Initially posted on 1/1/2001 and last modified 10/4/2021; though the study isn't acceptive of applicants right now, over one thousand two hundred forty-seven other trials are actively seeking enrollees."

Answered by AI

What attendant risks exist with administering pre-treatment tumour oxygen assessments?

"Our team appraised the security of Pre-treatment tumour oxygen measurements as a 2, since this is Phase 2, signifying that there are some indications of safety yet no proof for efficacy."

Answered by AI

In what population is this trial open to participation?

"This clinical trial is on the hunt for 195 individuals between 18 and 80 years old who possess a prostate cancer diagnosis. Other essential inclusion criteria include: histologically confirmed adenocarcinoma of the prostate, elective radiotherapy with or without neoadjuvant/concurrent hormone suppression therapy, T2a/T2b stage N0M0 (UICC 1997 68), no prior chemo-hormonal therapies, ECOG performance status ≤ 2, English language comprehension proficiency, and signed informed consent."

Answered by AI

Are applicants aged 35+ being considered for enrollment in this experiment?

"Consistent with the stated requirements, individuals aged 18 and above but no older than 80 are eligible to participate in this trial."

Answered by AI
~28 spots leftby Jan 2028