Imaging of High Grade Prostate Cancer

Not Applicable

Terminated

• Conditions: Prostatic Carcinoma
• Interventions: Device: Imaging

• Registration Number: NCT02177526
• Lead Sponsor: Ottawa Hospital Research Institute

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-25
• Study First Posted: 2014-06-27
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-17
• Last Update Posted: 2015-11-18
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 30

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imaging - CT and MRI examinations	Imaging	Abdominal and pelvic CT and pelvic MRI imaging will be performed in 30 patients.

Primary Outcome Measures

Name	Time	Method
The number of prostate patients with comedo-type necrosis.	up to 4 weeks	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

Name	Time	Method
The number of other features measured on MRI.	up to 4 weeks	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.

Trial Locations

Locations (1)

Ottawa Hospital (Civic Campus); 🇨🇦 Ottawa, Ontario, Canada