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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00676286
First received: May 12, 2008
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Prostate Cancer
Procedure: 3T MR Imaging
Procedure: C-Choline PET Scanning
Procedure: Gene Rearrangement
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • Primary objective to determine if we can accrue patients to this study in a timely manner. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient compliance [ Time Frame: Patients followed for 5 years from baseline ] [ Designated as safety issue: No ]
  • Optimal imaging parameters to characterize prostate cancers [ Time Frame: patients followed for 5 years from baseline ] [ Designated as safety issue: No ]
  • feasibility of detecting gene arrangements in prostate biopsies [ Time Frame: patients followed for 5 years from baseline ] [ Designated as safety issue: No ]
  • Incidence of patients developing progressive prostate cancer warranting definitive treatment in an active surveillance protocol [ Time Frame: patients followe for 5 years from baseline ] [ Designated as safety issue: No ]
  • The natural history of prostate cancer with these investigations [ Time Frame: patients followed for 5 years from baseline ] [ Designated as safety issue: No ]
  • The sensitivity and specificity of these investigation in detecting prostate cancer [ Time Frame: patients followed for 5 years from baseline ] [ Designated as safety issue: No ]
  • The sensitivity and specificity of these investigations in differentiating indolent prostate cancer from aggressive disease [ Time Frame: patients followed for 5 years from baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2008
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: 3T MR Imaging
    3TR Imaging
    Procedure: C-Choline PET Scanning
    C-Choline PET Scanning
    Procedure: Gene Rearrangement
    Gene Rearrangement
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00676286     History of Changes
Other Study ID Numbers: GU-24152
Study First Received: May 12, 2008
Last Updated: March 31, 2014
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 18, 2014