Prostate CancerNCT02131207
MRI Before Biopsy in Diagnosing Patients With Prostate Cancer
An observational study of Prostate Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This pilot clinical trial studies how well magnetic resonance imaging (MRI) before biopsy works in diagnosing patients with prostate cancer. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- magnetic resonance imaging and prostate biopsy
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2014to 8 Dec 2017
- Phase
- Observational
- 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 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: This is a pilot study of patients from the University Hospitals urology clinics who have not previously been given a diagnosis of prostate cancer but who are awaiting a prostate biopsy due to an elevated PSA or abnormal digital rectal exam
Who may be able to join
- Abnormal prostate-specific antigen (PSA) blood test
- > 2.5 ng/mL for men < 50 years (yrs) of age
- > 3.5 ng/mL for men < 60 yrs of age
- > 4.5 ng/mL for men < 70 yrs of age
- Abnormal digital rectal exam (i.e. palpable nodule, induration or firm area to the prostate)
- Scheduled for a TRUS biopsy based on clinical suspicion for prostate cancer
Who cannot join
- Individuals who have previously undergone biopsy of the prostate for diagnosis of prostate cancer
- Contraindications to TRUS/prostate biopsy (BX)
- Currently on blood thinning agents (Plavix, Coumadin etc.) or bleeding disorder
- Active urinary tract infection
- Acute painful perianal disorder (i.e. rectal abscess)
- Contraindications to MRI
Show all 12Show fewer
- Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips
- The presence of an implanted pacemaker or implanted defibrillator device
- Patients with contraindications for MRI due to embedded foreign metallic objects: bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient
- Implanted medical device not described above that is not MRI-compatible
- Known history of claustrophobia
- Individuals with a short life expectancy (< 10 years)
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Novel Screening MRI for the Detection of Prostate Cancer
This pilot clinical trial studies how well magnetic resonance imaging (MRI) before biopsy works in diagnosing patients with prostate cancer. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. This diagnostic procedure may aid in identifying lesions in the prostate which may have cancer. The lesions can then be targeted during the prostate biopsy to improve the accuracy of identifying prostate cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- Identification of one of more lesions suspicious for prostate cancer using a novel MRI protocol, not identified by transrectal ultrasound (TRUS) alone and to determine if the lesions identified by MRI demonstrate clinically significant prostate cancer based on pathologic findings (ie. Gleason >= 7 or percentage of core involved with cancer > 50%).
SECONDARY OBJECTIVES:
- Average time for MRI scan per patient. II. Correlation of lesions on MRI to radical prostatectomy specimens. III. To determine whether MRI 3 dimensional (3D) T2 half-Fourier acquired single turbo spin-echo (HASTE) or sampling perfection with application optimized contrast using different flip angle evolutions (SPACE) protocols provide improved rates of prostate cancer detection.
IV. Yield of additional clinically significant prostate cancer diagnoses based on MRI targeted lesions on biopsy.
- Rate of benign pathology identified by MRI (i.e. false positives). VI. To compare costs associated with the use of MRI over TRUS biopsy alone.
OUTLINE:
Participants undergo pelvic MRI. Within 1-2 weeks, patients undergo scheduled prostate biopsy.
- Conditions
- Prostate Cancer
- Being tested
- magnetic resonance imaging, prostate biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imagingDevice
Also called MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Undergo pelvic MRI
prostate biopsyProcedure or surgery
Also called biopsy of prostate, prostatic biopsy
Undergo prostate biopsy
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (MRI and biopsy) | Participants undergo pelvic magnetic resonance imaging (MRI). Within 1-2 weeks, patients undergo scheduled prostate biopsy. Receives: Device: magnetic resonance imaging; Procedure: prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased detection of clinically significant prostate cancer
Percent increase of patients with positive prostate cancer biopsies detected with pelvic MRI quick scan from the anticipated detection rate of 40%
Measured: Up to 1 year
Secondary outcomes (2)
Detection of clinically significant prostate cancer using 3D T2 SPACE
Number of patients with positive prostate cancer detection using 3D T2 SPACE
Measured: Up to 1 year
Detection of clinically significant prostate cancer using 3D T2 HASTE
Number of patients with positive prostate cancer detection using 3D T2 HASTE
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study start10 Sep 2014
- Primary completion8 Dec 2017
- Study completion8 Dec 2017
Why it stopped: Principal Investigator Left Institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert Abouassaly, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131207
- Sponsor's protocol ID
- CASE6813
- Other IDs
- NCI-2014-00822, CASE6813, P30CA043703
- Status last verified
- Dec 2017
- First submitted
- 17 Apr 2014
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Screening MRI for the Detection of Prostate Cancer
- ClinicalTrials.gov ID
- NCT02131207
- Acronym / sponsor ID
- CASE6813
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal Investigator Left Institution
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Sep 2014 (actual)
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- 8 Dec 2017 (actual)
- First posted
- 6 May 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.
This pilot clinical trial studies how well magnetic resonance imaging (MRI) before biopsy works in diagnosing patients with prostate cancer. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. This diagnostic procedure may aid in identifying lesions in the prostate which may have cancer. The lesions can then be targeted during the prostate biopsy to improve the accuracy of identifying prostate cancer.
Detailed description
PRIMARY OBJECTIVES:
- Identification of one of more lesions suspicious for prostate cancer using a novel MRI protocol, not identified by transrectal ultrasound (TRUS) alone and to determine if the lesions identified by MRI demonstrate clinically significant prostate cancer based on pathologic findings (ie. Gleason >= 7 or percentage of core involved with cancer > 50%).
SECONDARY OBJECTIVES:
- Average time for MRI scan per patient. II. Correlation of lesions on MRI to radical prostatectomy specimens. III. To determine whether MRI 3 dimensional (3D) T2 half-Fourier acquired single turbo spin-echo (HASTE) or sampling perfection with application optimized contrast using different flip angle evolutions (SPACE) protocols provide improved rates of prostate cancer detection.
IV. Yield of additional clinically significant prostate cancer diagnoses based on MRI targeted lesions on biopsy.
- Rate of benign pathology identified by MRI (i.e. false positives). VI. To compare costs associated with the use of MRI over TRUS biopsy alone.
OUTLINE:
Participants undergo pelvic MRI. Within 1-2 weeks, patients undergo scheduled prostate biopsy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (MRI and biopsy) | – | Device: magnetic resonance imaging, Procedure: prostate biopsyParticipants undergo pelvic magnetic resonance imaging (MRI). Within 1-2 weeks, patients undergo scheduled prostate biopsy. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a pilot study of patients from the University Hospitals urology clinics who have not previously been given a diagnosis of prostate cancer but who are awaiting a prostate biopsy due to an elevated PSA or abnormal digital rectal exam
Key inclusion criteria (6 listed)
- Abnormal prostate-specific antigen (PSA) blood test
- Abnormal digital rectal exam (i.e. palpable nodule, induration or firm area to the prostate)
- Scheduled for a TRUS biopsy based on clinical suspicion for prostate cancer
Key exclusion criteria (12 listed)
- Individuals who have previously undergone biopsy of the prostate for diagnosis of prostate cancer
- Contraindications to TRUS/prostate biopsy (BX)
- Contraindications to MRI
- Individuals with a short life expectancy (< 10 years)
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 |
|---|---|---|
| magnetic resonance imagingAlso: MRI, NMR imaging, NMRI, nuclear magnetic resonance imagingUndergo pelvic MRI | Device | Diagnostic (MRI and biopsy) |
| prostate biopsyAlso: biopsy of prostate, prostatic biopsyUndergo prostate biopsy | Procedure or surgery | Diagnostic (MRI and biopsy) |
Primary outcome
Increased detection of clinically significant prostate cancer
Time frame: Up to 1 year
Percent increase of patients with positive prostate cancer biopsies detected with pelvic MRI quick scan from the anticipated detection rate of 40%
2 secondary outcomes
Detection of clinically significant prostate cancer using 3D T2 SPACE
Time frame: Up to 1 year
Detection of clinically significant prostate cancer using 3D T2 HASTE
Time frame: Up to 1 year
Results and safety
The study was stopped early (reason given: Principal Investigator Left Institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2017.
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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.
Robert Abouassaly principal investigator
Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
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 6 inclusion and 12 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 21 Dec 2017. 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 United States. 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: Principal Investigator Left Institution). 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?
Increased detection of clinically significant prostate cancer (time frame: Up to 1 year). 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 21 Dec 2017.