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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676286
• Other study ID #: GU-24152
• Status: Completed
• Phase: Phase 1
• First received: May 12, 2008
• Last updated: July 4, 2016
• Start date: November 2008
• Est. completion date: March 2016

Study information

• Verified date: July 2016
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary objective to determine if we can accrue patients to this study in a timely manner.		2 years	No
Secondary	Patient compliance		Patients followed for 5 years from baseline	No
Secondary	Optimal imaging parameters to characterize prostate cancers		patients followed for 5 years from baseline	No
Secondary	feasibility of detecting gene arrangements in prostate biopsies		patients followed for 5 years from baseline	No
Secondary	Incidence of patients developing progressive prostate cancer warranting definitive treatment in an active surveillance protocol		patients followe for 5 years from baseline	No
Secondary	The natural history of prostate cancer with these investigations		patients followed for 5 years from baseline	No
Secondary	The sensitivity and specificity of these investigation in detecting prostate cancer		patients followed for 5 years from baseline	No
Secondary	The sensitivity and specificity of these investigations in differentiating indolent prostate cancer from aggressive disease		patients followed for 5 years from baseline	No
Secondary	The sensitivity and specificity of these investigations in detecting high grade disease, extracapsular disease and extraprostatic disease and disease progression		patients followed for 5 years from baseline	No