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NCT02095249Active, not recruiting

Prostate Hypoxia - TIC

Hypoxia and Stem Cell Content as Aggression Factors in Prostate Cancer

Source: ClinicalTrials.gov · Last updated 23 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
39 (actual)
First submitted
12 Mar 2014
Start date
1 Sept 2014
Primary completion date
31 Jan 2028
Lead sponsor
University Health Network, Toronto
NCT number
NCT02095249

What you commit to

  • Study type: Interventional
  • Participants enrolled: 39
  • From 1 Sept 2014 to the primary completion date, 31 Jan 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with clinical T4, N1 or M1 disease

Other

  • Patients with histologies other than adenocarcinoma
  • Patients unable to ingest pimonidazole tablets

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Health Network
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.