Your session is about to expire
← Back to Search
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quantitation of pimonidazole staining (a.u./cm2) in radical prostatectomy specimens as determinant of biochemical failure
Secondary outcome measures
Quantitation of tumour initial cells by immunohistochemistry (cells/mm2) in radical prostatectomy specimens as determinant of biochemical failure
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
1,471 Previous Clinical Trials
484,931 Total Patients Enrolled
63 Trials studying Prostate Cancer
15,361 Patients Enrolled for Prostate Cancer
Alejandro Berlin, MD.Principal InvestigatorUniversity Health Network, Toronto
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer is classified as adenocarcinoma.I have prostate cancer and will have surgery at Princess Margaret Cancer Centre-UHN.My cancer is not adenocarcinoma.You are not able to swallow pimonidazole tablets.My cancer is in stage T2-T3, has not spread to lymph nodes or other parts of the body.My prostate cancer has a Gleason score of 7 with more than half of biopsies showing cancer, or it is 8 or higher.My cancer has spread to nearby or distant parts of my body.
Research Study Groups:
This trial has the following groups:- Group 1: Pimonidazole
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have there been any other research efforts exploring this therapeutic approach?
"Presently, two clinical trials of this medication are live - neither in Phase 3. Both research sites are located in Toronto, Ontario."
Answered by AI
Are new participants currently being sought for this trial?
"This trial has already stopped enrolling new participants, with its first posting on September 1st 2014 and last update occurring October 4th 2021. Alternatively, there are 1478 other trials for prostate cancer currently recruiting, two of which involve the same treatment regimen as this study."
Answered by AI
How many participants are admitted to the experiment?
"Unfortunately, the recruiting period for this trial has concluded. It was first posted on September 1st 2014 and last updated October 4th 2021. If you are still searching for trials, there are currently 1478 trials actively seeking participants afflicted with prostate cancer while 2 studies related to this treatment remain open to new enrolment."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger