Clinical trial NCT00676286: Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19 in Prostate Cancer Using High Field MRI (3 Tesla), PET, and Biomarkers
Official title: Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: Prostate cancer active surveillance
3 Tesla MR biological imaging in prostate cancer
tumor gene re-arrangements in prostate cancer
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2008-05-13
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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 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

Primary outcomes:
measure: Primary objective to determine if we can accrue patients to this study in a timely manner.
timeFrame: 2 years
Secondary outcomes:
measure: Patient compliance
timeFrame: Patients followed for 5 years from baseline
measure: Optimal imaging parameters to characterize prostate cancers
timeFrame: patients followed for 5 years from baseline
measure: feasibility of detecting gene arrangements in prostate biopsies
timeFrame: patients followed for 5 years from baseline
measure: Incidence of patients developing progressive prostate cancer warranting definitive treatment in an active surveillance protocol
timeFrame: patients followe for 5 years from baseline
measure: The natural history of prostate cancer with these investigations
timeFrame: patients followed for 5 years from baseline
measure: The sensitivity and specificity of these investigation in detecting prostate cancer
timeFrame: patients followed for 5 years from baseline
measure: The sensitivity and specificity of these investigations in differentiating indolent prostate cancer from aggressive disease
timeFrame: patients followed for 5 years from baseline
measure: The sensitivity and specificity of these investigations in detecting high grade disease, extracapsular disease and extraprostatic disease and disease progression
timeFrame: patients followed for 5 years from baseline
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: Cross Cancer Institute
name: Nawaid Usmani, MD, FRCPC
role: STUDY_CHAIR
affiliation: Cross Cancer Institute
name: Nawaid Usmani, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: