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

• Sponsor: AHS Cancer Control Alberta (Other)
• Overall Status: Completed
• CT.gov ID: NCT00676286
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Duration (Months): 88
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Nov 1, 2008
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Patient compliance [Patients followed for 5 years from baseline]

2. Optimal imaging parameters to characterize prostate cancers [patients followed for 5 years from baseline]

3. feasibility of detecting gene arrangements in prostate biopsies [patients followed for 5 years from baseline]

4. Incidence of patients developing progressive prostate cancer warranting definitive treatment in an active surveillance protocol [patients followe for 5 years from baseline]

5. The natural history of prostate cancer with these investigations [patients followed for 5 years from baseline]

6. The sensitivity and specificity of these investigation in detecting prostate cancer [patients followed for 5 years from baseline]

7. The sensitivity and specificity of these investigations in differentiating indolent prostate cancer from aggressive disease [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 [patients followed for 5 years from baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AHS Cancer Control Alberta
• ClinicalTrials.gov Identifier: NCT00676286
• Other Study ID Numbers: GU-24152
• First Posted: May 13, 2008
• Last Update Posted: Jul 6, 2016
• Last Verified: Jul 1, 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; Choline

Study Results

No Results Posted as of Jul 6, 2016