Transrectal Tumour Oxygen - US Army

StatusCompleted
PhasePhase 2
Started

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Record History

  1. Minor Enrollment target: estimated 195 to confirmed 186v15
  2. Minor Trial status: Active, Not Recruiting to Completed
    • Primary and study completion dates changed from estimate of Jan 2028 to Feb 2023
    v14
  3. 3 versions Re-verified since Apr 1, 2021, no change to tracked fieldsv11-v13
  4. Notable Primary and study completion dates: Jan 2019 to Jan 2028v10
  5. Re-verified, no change to tracked fieldsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Notable Primary and study completion dates: Jan 2017 to Jan 2019v8
  2. Notable Primary and study completion dates: Jan 2016 to Jan 2017v7
  3. Notable Primary and study completion dates: Jan 2015 to Jan 2016v6
  4. Notable Primary and study completion dates: Jan 2014 to Jan 2015v5
  5. Notable Primary and study completion dates: Jan 2013 to Jan 2014v4
  6. Minor Study arms: 0 to 1v3
  7. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Jan 2013
    • Secondary endpoints: details revised at 3 of 3 entries
    • Site details revised
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Prostate cancer is now the most commonly diagnosed tumor among men in the United States. Most patients have tumors that are confined to the prostate gland at diagnosis and are suitable for treatment with surgery or radiotherapy (RT) that is aimed at curing the disease. Nevertheless, despite recent improvements in these treatments, a large number of men continue to die of prostate cancer. These patients often have spread of tumor to other areas of the body, and are treated with hormones that produce initial tumor shrinkage. However, over time the tumor learns to grow despite continued hormonal treatment. Effective therapy for patients with hormone-resistant prostate cancer is lacking and patients often deteriorate quickly and die. Thus, there is a need for better treatment that cures prostate cancer at an early stage, and a better understanding of the biology of prostate cancer specifically with respect to factors that determine the effectiveness of RT, the spread of tumor and the development of hormone-resistant disease. Low levels of oxygen (hypoxia) are known to exist in many human tumors, and studies have shown that hypoxic tumors are less likely to be cured by RT. In addition, hypoxia may lead to lower cure rates following surgery, spread of cancer to other areas of the body, and changes in the genetic characteristics of the cancer cells that cause them to behave more aggressively. The importance of hypoxia in prostate cancer has not previously been evaluated. The aims of this study are to determine how often hypoxia occurs in early prostate cancer and whether hypoxia influences the success of RT, tumor spread beyond the prostate to bones and other organs and the development of hormone-resistant disease. Patients will have tumor oxygen levels measured using a special fine-needle electrode system prior to beginning treatment with either RT or the combination of hormones plus RT. The measurements will be made through the rectum using ultrasound to position and guide the electrode. A biopsy of the tumor will be obtained at the site of the measurements, and this will be used to determine how oxygen influences changes in the genetic character of prostate cancer cells. A total of 195 patients will be evaluated in this way over 3 years. This study will provide unique information about the behavior of prostate cancer, which may help explain why currently available treatments including surgery, RT and hormones fail to cure patients. Assuming that this study shows hypoxia to be important in prostate cancer, future work will focus on new anti-hypoxia treatments to be used in combination with surgery or RT with the aim of overcoming this obstacle and improving cure rates.
Trial Details
NCT Number NCT00160979
Lead Sponsor University Health Network, Toronto
Collaborators: U.S. Army Medical Research and Development Command, Princess Margaret Hospital, Canada
Conditions
(from sponsor)
Prostatic Neoplasms
Related terms Prostatic Neoplasms
Enrollment 186 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov