Prostate CancerNCT03474913
Upright MRI for Prostate Cancer Screening
An observational study of Prostate Cancer and Elevated PSA, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This is an investigator initiated study to test the efficacy of an upright MRI (Magnetic Resonance Imaging) for the screening of prostate cancer. The purpose of this study is to compare Upright MRI as a technique to PSA (Prostate Specific Antigen) and current MRI imaging. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer, Elevated PSA, Elevated Prostate Specific Antigen
- What is being tested?
- Upright MRI and Standard MRI
- Type of treatment
- Medical device
- How many people
- 550 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men at risk for prostate cancer
Who may be able to join
- Men at risk of prostate cancer and have been advised to have a prostate MRI.
- Age ≥ 18 years.
- Fit for undergoing all study protocol procedures which includes an ultrasound guided biopsy.
- Able to tolerate general or spinal anesthesia.
- Ability to understand and the willingness to sign a written informed consent and to comply with the protocol.
Who cannot join
- Patients who have been treated using 5- alpha-reductase inhibitors at the time of study enrollment or 6 months prior to enrollment.
- Patients with previous history of prostate biopsy, prostate surgery or treatment for prostate cancer (interventions for benign prostatic hyperplasia/bladder outflow obstruction is acceptable)
- Patients who have evidence of a urinary tract infection or history of acute prostatitis within the last 3 months.
- Patients contraindicated to undergoing the MRI procedure e.g. pacemaker, estimated GFR<=50, automatic implantable cardiac defibrillators.
- History of any other medical condition precluding procedures described in the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Ash Tewari, MD
About this study
Official title: Feasibility and Efficacy of Upright MP - MRI for Prostate Cancer Screening
This is an investigator initiated study to test the efficacy of an upright MRI (Magnetic Resonance Imaging) for the screening of prostate cancer. The purpose of this study is to compare Upright MRI as a technique to PSA (Prostate Specific Antigen) and current MRI imaging. It will take place at Mount Sinai Hospital, and last for a total of about 5 years. Eligible patients will be determined by the urologist. The target population is men who are at risk for prostate cancer, as determined by the urologist. Diagnostic criteria will include elevated PSA and an abnormal digital rectal exam (DRE). After patients are screened and determined eligible, they will be asked to have a seated MRI using the Indomitable Magnetic Resonance Imaging Scanner, Ex vivo magnetic resonance imaging using 0.6 T strength, as well as a standard of care closed 3T MRI. After each scan, the patient will be given a series of questionnaires to assess their comfort level during the scan. Patients will be followed every 6 months after completion of (or early withdrawal from) study enrollment until 5 years.
Read the detailed description
Prostate cancer (PCa) is the second most common cancer among men in the United States, with over 180,000 new cases diagnosed in 2016. This commonality implies that set standards need to be set and devise effective tools to screen and diagnose prostate cancer. Today, prostate specific antigen (PSA) test is the most widely adopted screening method for PCa. Since its introduction in 1979, it has helped in earlier diagnosis of PCa and has had a marked shift on the stage at which PCa is identified. PSA, although popular as a screening tool, has several shortcomings. It is organ-specific rather than cancer-specific, which means that its values can be elevated even for non-malignant conditions . Indeed, PSA based screening has reported positive predictive value as low as 30% (PSA cutoff >4.0 ng/dL) for detecting prostate cancer and an over diagnosis rate of 50%, which leads to unnecessary biopsies and aggressive treatments of men with clinically indolent (insignificant) disease.
Current diagnostic pathway of prostate cancer requires men with elevated PSA and abnormal Digital Rectal exam to undergo a Trans Rectal Ultra Sound (TRUS) guided biopsy. TRUS is a blind-systematic biopsy, which randomly samples prostate tissue. This can lead to missing or under-diagnosing clinically significant cancer and over-diagnosing clinically insignificant disease. TRUS biopsy is itself associated with morbidity, mainly in the form of hematuria, hematospermia, pain, urinary retention and sometimes can cause life-threatening sepsis.
Many of the PSA screened detected prostate cancers detected on TRUS are clinically insignificant and even if left untreated have little to no clinical impact on an individual's remaining life. Overtreatment resulting from over diagnosis often leads to side effects like erectile dysfunction (approx. 60%) from radical therapy and urinary incontinence.
- Being tested
- Upright MRI, Standard MRI
- Keywords
- Prostate Cancer Diagnosis, Imaging, Magnetic Resonance Imaging, Cancer, Diagnostic, Malignant Neoplasm of Prostate
- Medical subject headings
- Prostatic Neoplasms, Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upright MRIDevice
Indomitable Magnetic Resonance Imaging Scanner, magnetic resonance imaging using 0.6 T strength
Standard MRIDevice
standard of care closed 3T MRI
| Study group | Role | What they receive |
|---|---|---|
| Standard MRI first | Patients will have a standard of care MRI, then consent to study participation and have an upright MRI. Receives: Device: Upright MRI | |
| MRIs in random order | Patients will consent to participate in the study, then do two MRIs in random order. Receives: Device: Upright MRI; Device: Standard MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA levels
Prostate-specific Antigen (PSA) levels
Measured: 5 years
Secondary outcomes (6)
Upright MRI compared to Standard MRI
To compare performance characteristics of Upright MP-MRI versus 3T MP-MRI in detecting clinically significant PCa and PCa in general.
Measured: 5 years
Claustrophobic Questionnaire (CLQ)
Claustrophobic Questionnaire (CLQ) is a 46 item instrument, each item score on a likert scale from 1-5, full scale from 36 to 180, with higher score indicating more anxiety.
Measured: 5 years
NCCN Distress Thermometer
NCCN Distress Thermometer is a visual scale - full scale from 0-10, higher score indicating higher level of distress
Measured: 5 years
Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ)
Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ) is a 15 item instrument, each item score on a likert scale from 1 to 4, full scale range from 15 to 66, with higher score indicating higher degree of anxiety.
Measured: 5 years
Diagnostic Yield of MRI and PSA Density
To compare the diagnostic yield of using MP-MRI with thresholds PSA density used for detecting prostate cancer.
Measured: 5 years
Number of Correctly Identified side
Number of correctly identified side of prostate unaffected in men with pathological disease
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start1 Oct 2018
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
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.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- The Fonar Corporation
- Responsible party
- Principal investigator, Ashutosh Kumar Tewari, Icahn School of Medicine at Mount Sinai
- Investigators
- Ash Tewari, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474913
- Sponsor's protocol ID
- GCO 17-2776
- Status last verified
- Jan 2026
- First submitted
- 16 Mar 2018
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of Upright MP - MRI for Prostate Cancer Screening
- ClinicalTrials.gov ID
- NCT03474913
- Acronym / sponsor ID
- GCO 17-2776
- Keywords
- Prostate Cancer Diagnosis, Imaging, Magnetic Resonance Imaging, Cancer, Diagnostic, Malignant Neoplasm of Prostate
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- The Fonar Corporation
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 23 Mar 2018 (actual)
- 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 is an investigator initiated study to test the efficacy of an upright MRI (Magnetic Resonance Imaging) for the screening of prostate cancer. The purpose of this study is to compare Upright MRI as a technique to PSA (Prostate Specific Antigen) and current MRI imaging. It will take place at Mount Sinai Hospital, and last for a total of about 5 years. Eligible patients will be determined by the urologist. The target population is men who are at risk for prostate cancer, as determined by the urologist. Diagnostic criteria will include elevated PSA and an abnormal digital rectal exam (DRE). After patients are screened and determined eligible, they will be asked to have a seated MRI using the Indomitable Magnetic Resonance Imaging Scanner, Ex vivo magnetic resonance imaging using 0.6 T strength, as well as a standard of care closed 3T MRI. After each scan, the patient will be given a series of questionnaires to assess their comfort level during the scan. Patients will be followed every 6 months after completion of (or early withdrawal from) study enrollment until 5 years.
Detailed description
Prostate cancer (PCa) is the second most common cancer among men in the United States, with over 180,000 new cases diagnosed in 2016. This commonality implies that set standards need to be set and devise effective tools to screen and diagnose prostate cancer. Today, prostate specific antigen (PSA) test is the most widely adopted screening method for PCa. Since its introduction in 1979, it has helped in earlier diagnosis of PCa and has had a marked shift on the stage at which PCa is identified. PSA, although popular as a screening tool, has several shortcomings. It is organ-specific rather than cancer-specific, which means that its values can be elevated even for non-malignant conditions . Indeed, PSA based screening has reported positive predictive value as low as 30% (PSA cutoff >4.0 ng/dL) for detecting prostate cancer and an over diagnosis rate of 50%, which leads to unnecessary biopsies and aggressive treatments of men with clinically indolent (insignificant) disease.
Current diagnostic pathway of prostate cancer requires men with elevated PSA and abnormal Digital Rectal exam to undergo a Trans Rectal Ultra Sound (TRUS) guided biopsy. TRUS is a blind-systematic biopsy, which randomly samples prostate tissue. This can lead to missing or under-diagnosing clinically significant cancer and over-diagnosing clinically insignificant disease. TRUS biopsy is itself associated with morbidity, mainly in the form of hematuria, hematospermia, pain, urinary retention and sometimes can cause life-threatening sepsis.
Many of the PSA screened detected prostate cancers detected on TRUS are clinically insignificant and even if left untreated have little to no clinical impact on an individual's remaining life. Overtreatment resulting from over diagnosis often leads to side effects like erectile dysfunction (approx. 60%) from radical therapy and urinary incontinence.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard MRI first | – | Device: Upright MRIPatients will have a standard of care MRI, then consent to study participation and have an upright MRI. |
| MRIs in random order | – | Device: Upright MRI, Device: Standard MRIPatients will consent to participate in the study, then do two MRIs in random order. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men at risk for prostate cancer
Key inclusion criteria (5 listed)
- Men at risk of prostate cancer and have been advised to have a prostate MRI.
- Age ≥ 18 years.
- Fit for undergoing all study protocol procedures which includes an ultrasound guided biopsy.
- Able to tolerate general or spinal anesthesia.
- Ability to understand and the willingness to sign a written informed consent and to comply with the protocol.
Key exclusion criteria (5 listed)
- Patients who have been treated using 5- alpha-reductase inhibitors at the time of study enrollment or 6 months prior to enrollment.
- Patients with previous history of prostate biopsy, prostate surgery or treatment for prostate cancer (interventions for benign prostatic hyperplasia/bladder outflow obstruction is acceptable)
- Patients who have evidence of a urinary tract infection or history of acute prostatitis within the last 3 months.
- Patients contraindicated to undergoing the MRI procedure e.g. pacemaker, estimated GFR<=50, automatic implantable cardiac defibrillators.
- History of any other medical condition precluding procedures described in the protocol
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 |
|---|---|---|
| Upright MRIIndomitable Magnetic Resonance Imaging Scanner, magnetic resonance imaging using 0.6 T strength | Device | MRIs in random order, Standard MRI first |
| Standard MRIstandard of care closed 3T MRI | Device | MRIs in random order |
Primary outcome
PSA levels
Time frame: 5 years
Prostate-specific Antigen (PSA) levels
6 secondary outcomes
Upright MRI compared to Standard MRI
Time frame: 5 years
Claustrophobic Questionnaire (CLQ)
Time frame: 5 years
NCCN Distress Thermometer
Time frame: 5 years
Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ)
Time frame: 5 years
Diagnostic Yield of MRI and PSA Density
Time frame: 5 years
Number of Correctly Identified side
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Prostate Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma
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.
Ash Tewari, MD principal investigator
Icahn School of Medicine at Mount Sinai
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 and Elevated PSA, run by Icahn School of Medicine at Mount Sinai 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 7 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monali Fatterpekar, Ph.D. ((212) 241-0751, monali.fatterpekar@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA levels (time frame: 5 years). 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 7 Jan 2026.