Prostate CancerNCT02095249
Prostate Hypoxia - TIC
A study testing Pimonidazole in people with Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Prostate cancer is the most commonly diagnosed form of cancer in Canadian men. In 2006, greater than 250,000 men were diagnosed with prostate cancer in the United States and Canada with more than 32,000 men dying of their disease. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Pimonidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prostate cancer patients with bulky intermediate risk or high-risk disease who have already agreed to undergo an open radical prostatectomy at Princess Margaret Cancer Centre-UHN:
- Clinical stage T2-T3 N0 M0
- Pathology of adenocarcinoma of the prostate AND
- Gleason score 7 with >/= 50 % biopsies involved with tumour; OR
- Gleason score 8 or above (any percentage of biopsies)
Who cannot join
- Patients with clinical T4, N1 or M1 disease
- Patients with histologies other than adenocarcinoma
- Patients unable to ingest pimonidazole tablets
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypoxia and Stem Cell Content as Aggression Factors in Prostate Cancer
Prostate cancer is the most commonly diagnosed form of cancer in Canadian men. In 2006, greater than 250,000 men were diagnosed with prostate cancer in the United States and Canada with more than 32,000 men dying of their disease. Using the prognostic variables of T-category, the serum prostate specific antigen (PSA), and the pathologic Gleason score (GS), men with localized prostate cancer are placed in low, intermediate and high-risk groupings. Usually this is treated with surgery, radiation therapy, hormone therapy and/or watchful waiting (also known as active surveillance). While these treatments are quite effective, tumours are likely to recur in about 40% of cases. There is a need for additional prostate cancer treatments. To address this need, many experimental therapies are being developed and tested in mice with prostate tumors. This includes the study of aggressive prostate cancer cells such as stem cells, or Tumour Initiating Cells (TICs), or oxygen deprived cells, which may be the ones most likely to re-grow into a tumour or spread throughout the body. Researchers want to try and isolate these special cells from the prostate after surgery to study their features, and to see if they can re-grow as solid tumours in mice. Researchers would like to test whether the prostate cancer stem cells are more resistant or less resistant to treatments. This will allow researchers to study and test new treatments that specifically target resistant and aggressive prostate cancer cells. The investigators hypothesize that marker-defined TIC cells or hypoxic cancer cells have unique genetics in primary prostate cancers and are relatively chemo- and radio-resistant.
- Conditions
- Prostate Cancer
- Being tested
- Pimonidazole
- Keywords
- prostate cancer, radical prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PimonidazoleDrug
Pimonidazole is to be administered to patients scheduled for radical prostatectomy one day prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Pimonidazole | Other | Not described Receives: Drug: Pimonidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitation of pimonidazole staining (a.u./cm2) in radical prostatectomy specimens as determinant of biochemical failure
Radical prostatectomy specimens will stained for pimonidazole uptake using antibody-based immunofluorescence assays
Measured: 3 years
Secondary outcomes (1)
Quantitation of tumour initial cells by immunohistochemistry (cells/mm2) in radical prostatectomy specimens as determinant of biochemical failure
Radical prostatectomy specimens will stained for cell surface markers pertaining to tumor initiating cells using immunofluorescence assays
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alejandro Berlin, MD., Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095249
- Sponsor's protocol ID
- UHN REB 13-7172-C
- Status last verified
- Jun 2026
- First submitted
- 12 Mar 2014
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoxia and Stem Cell Content as Aggression Factors in Prostate Cancer
- ClinicalTrials.gov ID
- NCT02095249
- Acronym / sponsor ID
- UHN REB 13-7172-C
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, radical prostatectomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 24 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prostate cancer is the most commonly diagnosed form of cancer in Canadian men. In 2006, greater than 250,000 men were diagnosed with prostate cancer in the United States and Canada with more than 32,000 men dying of their disease. Using the prognostic variables of T-category, the serum prostate specific antigen (PSA), and the pathologic Gleason score (GS), men with localized prostate cancer are placed in low, intermediate and high-risk groupings. Usually this is treated with surgery, radiation therapy, hormone therapy and/or watchful waiting (also known as active surveillance). While these treatments are quite effective, tumours are likely to recur in about 40% of cases. There is a need for additional prostate cancer treatments. To address this need, many experimental therapies are being developed and tested in mice with prostate tumors. This includes the study of aggressive prostate cancer cells such as stem cells, or Tumour Initiating Cells (TICs), or oxygen deprived cells, which may be the ones most likely to re-grow into a tumour or spread throughout the body. Researchers want to try and isolate these special cells from the prostate after surgery to study their features, and to see if they can re-grow as solid tumours in mice. Researchers would like to test whether the prostate cancer stem cells are more resistant or less resistant to treatments. This will allow researchers to study and test new treatments that specifically target resistant and aggressive prostate cancer cells. The investigators hypothesize that marker-defined TIC cells or hypoxic cancer cells have unique genetics in primary prostate cancers and are relatively chemo- and radio-resistant.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pimonidazole | Other | Drug: Pimonidazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Prostate cancer patients with bulky intermediate risk or high-risk disease who have already agreed to undergo an open radical prostatectomy at Princess Margaret Cancer Centre-UHN:
- Clinical stage T2-T3 N0 M0
- Pathology of adenocarcinoma of the prostate AND
- Gleason score 7 with >/= 50 % biopsies involved with tumour; OR
- Gleason score 8 or above (any percentage of biopsies)
Key exclusion criteria (3 listed)
- Patients with clinical T4, N1 or M1 disease
- Patients with histologies other than adenocarcinoma
- Patients unable to ingest pimonidazole tablets
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PimonidazolePimonidazole is to be administered to patients scheduled for radical prostatectomy one day prior to surgery. | Drug | Pimonidazole |
Primary outcome
Quantitation of pimonidazole staining (a.u./cm2) in radical prostatectomy specimens as determinant of biochemical failure
Time frame: 3 years
Radical prostatectomy specimens will stained for pimonidazole uptake using antibody-based immunofluorescence assays
1 secondary outcome
Quantitation of tumour initial cells by immunohistochemistry (cells/mm2) in radical prostatectomy specimens as determinant of biochemical failure
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Berlin, MD. principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pimonidazole in people with Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitation of pimonidazole staining (a.u./cm2) in radical prostatectomy specimens as determinant of biochemical failure (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.