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Imaging of High Grade Prostate Cancer

Primary Purpose

Prostatic Carcinoma

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Imaging
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostatic Carcinoma focused on measuring CT, MRI

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with malignant comedo-type necrosis and calcifications detected with histo-pathology from guided biopsies
  • Patients with biopsy proven Gleason pattern 5 tumor and without comedo-type necrosis associated calcification

Exclusion Criteria:

  • Patients who do not have malignant comedo-type necrosis and calcifications detected with histo-pathology from guided biopsies

Sites / Locations

  • Ottawa Hospital (Civic Campus)

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Imaging - CT and MRI examinations

Arm Description

Abdominal and pelvic CT and pelvic MRI imaging will be performed in 30 patients.

Outcomes

Primary Outcome Measures

The number of prostate patients with comedo-type necrosis.
Two radiologists will review the MRI and CT examinations separated by a 4 week interval to decrease recall bias. Further, readers will review the 3 additional gradient echo pulse sequences independently at 3 different MRI reading sessions, also separated by 4 weeks, in order to compare the accuracy from each pulse sequence and to reduce recall bias.

Secondary Outcome Measures

The number of other features measured on MRI.
Two radiologists will review the MRI and CT examinations separated by a 4 week interval to compare other MRI features and clinical factors between Gleason pattern 5 tumors with and without malignant calcification.

Full Information

First Posted
June 18, 2014
Last Updated
November 17, 2015
Sponsor
Ottawa Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02177526
Brief Title
Imaging of High Grade Prostate Cancer
Official Title
Detection of Malignant Calcifications in High Grade Prostate Cancer With Comedo-type Necrosis Using Thin Section Computed Tomography and Susceptibility Weighted Magnetic Resonance Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
trial logistics
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Management of prostatic carcinoma varies according to stage of disease. Trans-rectal ultrasound guided biopsy is known to underestimate the degree of tumor due to undersampling and random non-targeted technique. Methods to improve pre-operative tumor localization and grading, including multi-parametric (MP) magnetic resonance imaging (MRI) is an active area of research but requires further validation. High grade tumors can undergo comedo-type necrosis with malignant calcifications which only occurs in Gleason pattern 5 tumors and which we hypothesize can be reliably detected using computed tomography (CT) and/or MRI. Detection of malignant calcification within tumor foci will improve the accuracy of localization and grading in prostatic carcinoma.
Detailed Description
High grade (Gleason pattern 5) tumors can undergo comedo-type necrosis producing malignant calcifications which we hypothesize can be reliably detected using computed tomography (CT) and/or MRI. Detection of malignant calcifications in areas of Gleason pattern 5 tumor will improve the accuracy of pre-operative localization and grading in prostatic carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Carcinoma
Keywords
CT, MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imaging - CT and MRI examinations
Arm Type
Other
Arm Description
Abdominal and pelvic CT and pelvic MRI imaging will be performed in 30 patients.
Intervention Type
Device
Intervention Name(s)
Imaging
Other Intervention Name(s)
CT, MRI
Intervention Description
15 patients with malignant comedo-type necrosis and calcifications detected with histo-pathology from guided biopsies will be enrolled after obtaining informed consent. 15 patients with biopsy proven Gleason pattern 5 tumor and without comedo-type necrosis associated calcification will serve as a comparison group after providing informed consent for a total of 30 patients.
Primary Outcome Measure Information:
Title
The number of prostate patients with comedo-type necrosis.
Description
Two radiologists will review the MRI and CT examinations separated by a 4 week interval to decrease recall bias. Further, readers will review the 3 additional gradient echo pulse sequences independently at 3 different MRI reading sessions, also separated by 4 weeks, in order to compare the accuracy from each pulse sequence and to reduce recall bias.
Time Frame
up to 4 weeks
Secondary Outcome Measure Information:
Title
The number of other features measured on MRI.
Description
Two radiologists will review the MRI and CT examinations separated by a 4 week interval to compare other MRI features and clinical factors between Gleason pattern 5 tumors with and without malignant calcification.
Time Frame
up to 4 weeks

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with malignant comedo-type necrosis and calcifications detected with histo-pathology from guided biopsies Patients with biopsy proven Gleason pattern 5 tumor and without comedo-type necrosis associated calcification Exclusion Criteria: Patients who do not have malignant comedo-type necrosis and calcifications detected with histo-pathology from guided biopsies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Schieda, MD
Organizational Affiliation
OHRI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ottawa Hospital (Civic Campus)
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Imaging of High Grade Prostate Cancer

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