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Prostate Hypoxia - TIC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02095249
Recruitment Status : Recruiting
First Posted : March 24, 2014
Last Update Posted : April 19, 2019
Information provided by (Responsible Party):
University Health Network, Toronto

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Pimonidazole Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Hypoxia and Stem Cell Content as Aggression Factors in Prostate Cancer
Study Start Date : September 2014
Estimated Primary Completion Date : January 2028
Estimated Study Completion Date : January 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Pimonidazole Drug: Pimonidazole
Pimonidazole is to be administered to patients scheduled for radical prostatectomy one day prior to surgery.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Quantitation of tumour initial cells by immunohistochemistry (cells/mm2) in radical prostatectomy specimens as determinant of biochemical failure [ Time Frame: 3 years ]
    Radical prostatectomy specimens will stained for cell surface markers pertaining to tumor initiating cells using immunofluorescence assays

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Patients with clinical T4, N1 or M1 disease
  • Patients with histologies other than adenocarcinoma
  • Patients unable to ingest pimonidazole tablets

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02095249

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Contact: Alejandro Berlin, MD 416-946-4501 ext 5813

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Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G2M9
Contact: Alejandro Berlin, MD    416-946-4501 ext 5813   
Principal Investigator: Alejandro Berlin, MD         
Sub-Investigator: Neil Fleshner, MD         
Sub-Investigator: Theodorus Van Der Kwast, MD         
Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: Alejandro Berlin, MD. University Health Network, Toronto
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Responsible Party: University Health Network, Toronto Identifier: NCT02095249    
Other Study ID Numbers: UHN REB 13-7172-C
First Posted: March 24, 2014    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Keywords provided by University Health Network, Toronto:
prostate cancer
radical prostatectomy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms