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临床试验/NCT02095249
NCT02095249进行中(未招募)不适用

Hypoxia and Stem Cell Content as Aggression Factors in Prostate Cancer

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2014年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
39
试验地点
2
主要终点
Quantitation of pimonidazole staining (a.u./cm2) in radical prostatectomy specimens as determinant of biochemical failure

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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)

排除标准

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

研究组 & 干预措施

Pimonidazole

Other

干预措施: Pimonidazole (Drug)

结局指标

主要结局

Quantitation of pimonidazole staining (a.u./cm2) in radical prostatectomy specimens as determinant of biochemical failure

时间窗: 3 years

Radical prostatectomy specimens will stained for pimonidazole uptake using antibody-based immunofluorescence assays

次要结局

  • Quantitation of tumour initial cells by immunohistochemistry (cells/mm2) in radical prostatectomy specimens as determinant of biochemical failure(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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