Imaging of High Grade Prostate Cancer

NCT02177526 | Terminated

• 1 other identifier: Malignant Prostate 100
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Carcinoma

Keywords

CT; MRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The number of other features measured on MRI.

  up to 4 weeks

Study Arms (1)

Imaging - CT and MRI examinations

OTHER

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

Device: Imaging

Interventions

Imaging DEVICE

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.

Also known as: CT, MRI

Imaging - CT and MRI examinations

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital (Civic Campus)

Ottawa, Ontario, K1Y 4E9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Diagnostic Imaging

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)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Nick Schieda, MD

  OHRI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: June 27, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 18, 2015

Record last verified: 2015-11

Locations

CA (1)