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

NCT00676286 | Completed Phase 1 DMC

• 1 other identifier: GU-24152
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer active surveillance; 3 Tesla MR biological imaging in prostate cancer; tumor gene re-arrangements in prostate cancer

Outcome Measures

Primary Outcomes (1)

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

  2 years

Secondary Outcomes (8)

• Patient compliance

  Patients followed for 5 years from baseline

• Optimal imaging parameters to characterize prostate cancers

  patients followed for 5 years from baseline

• feasibility of detecting gene arrangements in prostate biopsies

  patients followed for 5 years from baseline

• Incidence of patients developing progressive prostate cancer warranting definitive treatment in an active surveillance protocol

  patients followe for 5 years from baseline

• The natural history of prostate cancer with these investigations

  patients followed for 5 years from baseline

Interventions

3T MR Imaging PROCEDURE

3TR Imaging

C-Choline PET Scanning PROCEDURE

C-Choline PET Scanning

Gene Rearrangement PROCEDURE

Gene Rearrangement

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Gene Rearrangement

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

• Nawaid Usmani, MD, FRCPC

  Cross Cancer Institute

  STUDY CHAIR

• Nawaid Usmani, MD, FRCPC

  Cross Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2008
• First Posted: May 13, 2008
• Study Start: November 1, 2008
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 6, 2016

Record last verified: 2016-07

Locations

CA (1)