Imaging of High Grade Prostate Cancer

Not Applicable

Terminated

• Conditions: Prostatic Carcinoma

• 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.

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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