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Transrectal Tumour Oxygen - US Army

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. Read our disclaimer for details. Identifier: NCT00160979
Recruitment Status : Active, not recruiting
First Posted : September 12, 2005
Last Update Posted : April 19, 2019
U.S. Army Medical Research and Development Command
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Procedure: Pre-treatment tumour oxygen measurements Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Study of Transrectal Tumour Oxygen Measurements in Patients With Clinically Localized Prostate Cancer
Study Start Date : January 2001
Estimated Primary Completion Date : January 2028
Estimated Study Completion Date : January 2028

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: hypoxia and RT in prostate cancer Procedure: Pre-treatment tumour oxygen measurements
Pre-treatment tumour oxygen measurements

Primary Outcome Measures :
  1. To determine the relationship between pre-treatment prostate cancer oxygen levels and long-term disease control following treatment with radiotherapy, and the independent prognostic effect of oxygen measurements. [ Time Frame: after follow-up is completed ]
  2. To determine the relationship between pre-treatment tumor oxygen levels and mutations of the p53 gene, and the impact of this interaction on patient outcome. [ Time Frame: after follow up is completed ]

Secondary Outcome Measures :
  1. To evaluate oxygen levels in clinically localized prostate cancer prior to treatment. [ Time Frame: after follow-up is completed ]
  2. To determine the relationship between pre-treatment tumor oxygen levels and the subsequent development of metastases and androgen-resistant prostate cancer. [ Time Frame: after follow is completed ]
  3. To determine whether androgen ablation overcomes any adverse effect of hypoxia on outcome. [ Time Frame: after follow up is completed ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • A histologic diagnosis of adenocarcinoma of the prostate
  • A decision to treat using high-dose conformal radiotherapy, with or without neoadjuvant and concurrent androgen ablation
  • Clinical stage T2a or T2b, N0, M0 (UICC 1997 68)
  • No hormonal or cytotoxic anti-cancer therapy prior to study entry
  • ECOG performance status of 2 or less
  • Ability to understand the English language
  • Signed informed consent

Exclusion Criteria:

  • Patients with prior or active malignancy within 5 years of the diagnosis of prostate cancer, except non-melanoma skin cancer

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): NCT00160979

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Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
U.S. Army Medical Research and Development Command
Princess Margaret Hospital, Canada
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Principal Investigator: Michael Milosevic, MD Princess Margaret Hospital, Canada
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Responsible Party: University Health Network, Toronto Identifier: NCT00160979    
Other Study ID Numbers: UHN REB 00-0443-C
US Army DAMD17-01-1-0111
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases