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Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19 in Prostate Cancer Using High Field MRI (3 Tesla), PET, and Biomarkers

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ClinicalTrials.gov Identifier: NCT00676286
Recruitment Status : Completed
First Posted : May 13, 2008
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Brief Summary:
This study will use high field MRI (3 Tesla), PET and biomarker to follow prostate cancers and determine if these tests can detect cancers that become aggressive.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: 3T MR Imaging Procedure: C-Choline PET Scanning Procedure: Gene Rearrangement Phase 1

Detailed Description:
This study may lead to the identification of additional investigations that can monitor for signs of disease progression in active surveillance protocols. This can directly benefit patients by providing them with greater confidence that their disease is being accurately monitored. In addition, this study may be beneficial to the general management of prostate cancers by adding to our knowledge of these investigations characterizing prostate cancers.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19
Study Start Date : November 2008
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer


Intervention Details:
  • Procedure: 3T MR Imaging
    3TR Imaging
  • Procedure: C-Choline PET Scanning
    C-Choline PET Scanning
  • Procedure: Gene Rearrangement
    Gene Rearrangement


Primary Outcome Measures :
  1. Primary objective to determine if we can accrue patients to this study in a timely manner. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Patient compliance [ Time Frame: Patients followed for 5 years from baseline ]
  2. Optimal imaging parameters to characterize prostate cancers [ Time Frame: patients followed for 5 years from baseline ]
  3. feasibility of detecting gene arrangements in prostate biopsies [ Time Frame: patients followed for 5 years from baseline ]
  4. Incidence of patients developing progressive prostate cancer warranting definitive treatment in an active surveillance protocol [ Time Frame: patients followe for 5 years from baseline ]
  5. The natural history of prostate cancer with these investigations [ Time Frame: patients followed for 5 years from baseline ]
  6. The sensitivity and specificity of these investigation in detecting prostate cancer [ Time Frame: patients followed for 5 years from baseline ]
  7. The sensitivity and specificity of these investigations in differentiating indolent prostate cancer from aggressive disease [ Time Frame: patients followed for 5 years from baseline ]
  8. The sensitivity and specificity of these investigations in detecting high grade disease, extracapsular disease and extraprostatic disease and disease progression [ Time Frame: patients followed for 5 years from baseline ]


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

Inclusion Criteria:

  • Histologically proven adenocarcinoma of the prostate
  • Registration must occur within 16 weeks of last biopsy
  • History and physical exam (including DRE) within 8 weeks prior to registration
  • Patients must have indolent prostate cancer including all of the following: Low risk prostate cancer, less or equal to 50 % of core biopsies involved with disease, and less or equal to three biopsies involved with disease
  • Patients must have a minimum of six biopsies (sextant) at registration
  • PSA test within 8 weeks registration
  • Creatinine level below 100 umol/L within 8 weeks of registration
  • Patients must have no contraindications to MRI scans
  • No history of previous malignancies except non-melanoma skin tumors or other malignancies with a greater than 5 year life expectancy
  • Patients must be reliable for follow up

Exclusion Criteria:

  • Patient does not have histologically-proven adenocarcinoma of the prostate
  • Last biopsy greater than 16 weeks prior to registration
  • History and physical exam (including DRE) greater that 8 weeks prior to registration
  • Patient does not have indolent disease
  • Patient has less than six sextant biopsies at registration
  • PSA test done greater than 8 weeks from registration
  • Creatinine level greater than 100 umol/L within 8 weeks of registration
  • Contraindications to MRI scans
  • History of previous malignancies other than non-melanoma skin tumors or other malignancies with a greater than 5 year life expectancy
  • Patients that are not reliable for follow up

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 ClinicalTrials.gov identifier (NCT number): NCT00676286


Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Study Chair: Nawaid Usmani, MD, FRCPC Cross Cancer Institute
Principal Investigator: Nawaid Usmani, MD, FRCPC Cross Cancer Institute

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00676286     History of Changes
Other Study ID Numbers: GU-24152
First Posted: May 13, 2008    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016

Keywords provided by AHS Cancer Control Alberta:
Prostate cancer active surveillance
3 Tesla MR biological imaging in prostate cancer
tumor gene re-arrangements in prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents