Prostatic CarcinomaNCT02177526
Imaging of High Grade Prostate Cancer
A study testing Imaging in people with Prostatic Carcinoma, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Carcinoma
- What is being tested?
- Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who do not have malignant comedo-type necrosis and calcifications detected with histo-pathology from guided biopsies
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Prostatic Carcinoma
- Being tested
- Imaging
- Keywords
- CT, MRI
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImagingDevice
Also called CT, MRI
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.
| Study group | Role | What they receive |
|---|---|---|
| Imaging - CT and MRI examinations | Other | Abdominal and pelvic CT and pelvic MRI imaging will be performed in 30 patients. Receives: Device: Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 4 weeks
Secondary outcomes (1)
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.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Why it stopped: trial logistics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic CarcinomaStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nick Schieda, MD, Principal investigator, OHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177526
- Sponsor's protocol ID
- Malignant Prostate 100
- Status last verified
- Nov 2015
- First submitted
- 18 Jun 2014
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02177526
- Acronym / sponsor ID
- Malignant Prostate 100
- Conditions
- Prostatic Carcinoma
- Keywords
- CT, MRI
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: trial logistics
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 27 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging - CT and MRI examinations | Other | Device: ImagingAbdominal and pelvic CT and pelvic MRI imaging will be performed in 30 patients. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who do not have malignant comedo-type necrosis and calcifications detected with histo-pathology from guided biopsies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImagingAlso: CT, MRI15 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. | Device | Imaging - CT and MRI examinations |
Primary outcome
The number of prostate patients with comedo-type necrosis.
Time frame: 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.
1 secondary outcome
The number of other features measured on MRI.
Time frame: up to 4 weeks
Results and safety
The study was stopped early (reason given: trial logistics). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick Schieda, MD principal investigator
OHRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaging in people with Prostatic Carcinoma, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: trial logistics). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of prostate patients with comedo-type necrosis. (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.