Prostate Hypoxia - TIC

Prostate Cancer Clinical Trial

Official title:

Hypoxia and Stem Cell Content as Aggression Factors in Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02095249
• Other study ID #: UHN REB 13-7172-C
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2014
• Est. completion date: January 2028

Study information

• Verified date: June 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 39
• Est. completion date: January 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoxia
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Pimonidazole
Pimonidazole is to be administered to patients scheduled for radical prostatectomy one day prior to surgery.

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 years
Secondary	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	3 years