Imaging of High Grade Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Detection of Malignant Calcifications in High Grade Prostate Cancer With Comedo-type Necrosis Using Thin Section Computed Tomography and Susceptibility Weighted Magnetic Resonance Imaging

Conditions
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Prostatic Carcinoma

Intervention / Treatment
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* Device: Imaging


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Imaging - CT and MRI examinations<br>Abdominal and pelvic CT and pelvic MRI imaging will be performed in 30 patients. | Device: Imaging<br>* 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.<br>* Other names: MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CT, MRI