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Completed

NCT Number: NCT00676286

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3T MR Imaging

Procedure

3TR Imaging

C-Choline PET Scanning

Procedure

C-Choline PET Scanning

Gene Rearrangement

Procedure

Gene Rearrangement

Primary outcomes

  1. Primary objective to determine if we can accrue patients to this study in a timely manner.

    Time frame: 2 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

AHS Cancer Control Alberta

Other

Registry information

Official study title

Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
May 13, 2008
Registry last updated
Jul 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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