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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after follow up is completed

Awards & highlights

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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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.

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

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,468 Previous Clinical Trials

484,295 Total Patients Enrolled

64 Trials studying Prostate Cancer

15,400 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

285 Previous Clinical Trials

244,964 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