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Pimonidazole for Prostate Cancer

N/A
Waitlist Available
Led By Alejandro Berlin, 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
Clinical stage T2-T3 N0 M0
Gleason score 7 with >/= 50 % biopsies involved with tumour; OR Gleason score 8 or above (any percentage of biopsies)
Must not have
Patients with histologies other than adenocarcinoma
Patients with clinical T4, N1 or M1 disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether aggressive prostate cancer cells are more resistant to treatments.

Who is the study for?
This trial is for men with intermediate to high-risk prostate cancer who are set to have surgery at Princess Margaret Cancer Centre-UHN. They should have a Gleason score of 7 with more than half of biopsies showing tumor, or score 8+. The cancer must be adenocarcinoma and not spread beyond the prostate (T2-T3 N0 M0). Men can't join if they can't take pimonidazole tablets or if their cancer has spread further (T4, N1, M1) or isn't adenocarcinoma.
What is being tested?
The study is testing Pimonidazole in patients undergoing surgery for prostate cancer. It aims to isolate aggressive cancer cells from removed prostates to see how they behave and respond to treatments when grown in mice. This could help develop therapies targeting resistant prostate cancer cells.
What are the potential side effects?
While specific side effects of Pimonidazole aren't listed here, it's common for such drugs used in research settings to potentially cause digestive issues, reactions where the drug enters the body, and changes in blood tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is in stage T2-T3, has not spread to lymph nodes or other parts of the body.
Select...
My prostate cancer has a Gleason score of 7 with more than half of biopsies showing cancer, or it is 8 or higher.
Select...
My prostate cancer is classified as adenocarcinoma.
Select...
I have prostate cancer and will have surgery at Princess Margaret Cancer Centre-UHN.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer is not adenocarcinoma.
Select...
My cancer has spread to nearby or distant parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Quantitation of pimonidazole staining (a.u./cm2) in radical prostatectomy specimens as determinant of biochemical failure
Secondary study objectives
Quantitation of tumour initial cells by immunohistochemistry (cells/mm2) in radical prostatectomy specimens as determinant of biochemical failure

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: PimonidazoleExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pimonidazole
Not yet FDA approved

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,527 Previous Clinical Trials
503,507 Total Patients Enrolled
65 Trials studying Prostate Cancer
15,553 Patients Enrolled for Prostate Cancer
Alejandro Berlin, MD.Principal InvestigatorUniversity Health Network, Toronto

Media Library

Pimonidazole Clinical Trial Eligibility Overview. Trial Name: NCT02095249 — N/A
Prostate Cancer Research Study Groups: Pimonidazole
Prostate Cancer Clinical Trial 2023: Pimonidazole Highlights & Side Effects. Trial Name: NCT02095249 — N/A
Pimonidazole 2023 Treatment Timeline for Medical Study. Trial Name: NCT02095249 — N/A
~9 spots leftby Jan 2028
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