Prostate CancerNCT04692675
Multiparametric Magnetic Resonance Imaging of the Prostate to Assess Disease Progression and Genomics in Patients Undergoing Active Surveillance for Prostate Cancer
A study testing mpMRI in people with Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Active surveillance (AS) is a standard approach to treat low and intermediate risk prostate cancer. For AS, disease progression is monitored. AS uses biopsies, prostate specific antigen (PSA) blood tests, and other tools. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- mpMRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2022to 1 Sep 2031
- Phase
- Interventional
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have confirmed histopathological diagnosis of adenocarcinoma of the prostate within 2 years prior to study entry. Pathologic diagnosis must be confirmed by Laboratory of Pathology, NCI. If archival tissue is unavailable or insufficient for this purpose, a fresh biopsy will be collected.
- Biopsy confirmed prostate cancer with Gleason less than or equal to 3+4=7 (primary pattern 3)
- Clinical stage: cT1C or cT2A
- Adult males, greater than or equal to 18 years old
- NOTE: Children are excluded because prostate cancer is not common in pediatric populations. Women are not eligible because this disease occurs only in men.
- Ability of subject to understand and the willingness to sign a written informed consent document All participants should have a consent signed that demonstrates an understanding of active surveillance and the decision to choose active surveillance for their prostate cancer.
- Subjects must be co-enrolled to NCI protocol 16-C-0010 Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue
Who cannot join
- Metastatic prostate cancer/locally advanced disease
- Previous radiation to the pelvis
- Contraindications to prostate biopsy, including:
- Bleeding disorder that is not currently treated and stable with normal INR values greater than 2 and PT, PTT less than or equal to 1.5 times the upper limit of normal value.
- Severe immunocompromise with CD4 count of less than 200 in HIV patients and bone marrow transplantation patients and or patients with severe combined immunodeficiency.
- Severe hemorrhoids grade 3 and above
Show all 11Show fewer
- Prior surgery in the pelvis that prevents accurate imaging or biopsy including low anterior resection or abdominoperineal resection.
- Prior focal or whole gland therapy of the prostate for prostate cancer
- Contraindication to mpMRI, including allergy or sensitivity to contrast agents or insufficient renal function to safely tolerate MRI contrast agent
- mpMRI evidence of greater than or equal to T3 disease, including seminal vesicle invasion (SVI), extraprostatic extension (EPE) or locoregional spread of disease
- Any other medical conditions deemed by the PI or associates to make the participants ineligible for protocol procedures
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
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office, 888-624-1937
About this study
Background:
Active surveillance (AS) is a standard approach to treat low and intermediate risk prostate cancer. For AS, disease progression is monitored. AS uses biopsies, prostate specific antigen (PSA) blood tests, and other tools. Researchers want to see if multiparametric magnetic resonance imaging (mpMRI) can help improve AS.
Read more
Objective:
To see if mpMRI can improve how people are monitored during AS.
Eligibility:
Men age 18 and older who have been diagnosed with prostate cancer within the last 2 years.
Design:
Participants will undergo AS. Their PSA level will be checked once a year via blood test. They will have a digital rectal exam once a year.
Participants will have biopsies every 2-3 years. Needles will be put into different parts of the prostate. The needles are guided by ultrasound imaging.
Participants will also have targeted biopsies with mpMRI and MRI guided fusion (MRI-US fusion). MRI-US fusion combines previous MRI images with live ultrasound images. For MRIs, participants will lie on their stomach on the scanner table. A coil may be placed in the rectum.
Participants will have a physical exam and medical record review at least every 3 years. Their weight and vital signs will be checked. They will give data about their daily activities, side effects, and symptoms.
Every 2-3 years, participants will fill out surveys about their prostate health and quality of life.
Participants may give blood, urine, prostate secretion, and saliva samples. The samples will be used for research.
Participation will last for as long as the participant does not need actual treatment for his prostate cancer.
Read the detailed description
Background:
- Active Surveillance (AS) is a standard approach in the treatment of low and intermediate risk prostate cancer which employs a strategy of monitoring the clinical progression of prostate cancer.
- AS utilizes prostate biopsies, prostate specific antigen (PSA), and digital rectal examinations (DRE) as tools to determine clinical progression in prostate cance
- This protocol aims to assess an additional tool, multiparametric magnetic resonance imaging (mpMRI) to actively visualize and monitor disease within the prostate in addition to standard instruments used to determine clinical progression of disease.
Objectives:
- To determine the role of mpMRI in the selection and management of participants for AS by correlating imaging findings with pathological progression as determined on serial biopsies.
- To determine the optimal interval of MR imaging in monitoring AS participants for evidence of progression by correlating sequential MRIs with biopsies with the goal to reduce unnecessary imaging.
- To evaluate the relationship between mpMRI, prostate biopsy pathology results, and progression in AS participants to determine if prostate biopsies may be safely avoided based on the accuracy of imaging (sensitivity and specificity).
Eligibility:
- Men, 18 years and older with biopsy confirmed prostate cancer
- Gleason Score which less than or equal to 3+4=7
- Initial diagnosis of prostate cancer within 2 years of study entry
- Capable of being consented to the protocol
Design:
- Single arm, prospective, cohort study to correlate mpMRI with prostate biopsy pathology.
- We plan to accrue 508 participants over the entire study period, assuming about a 10% dropout to allow adequate statistical review.
- Participants will be monitored for clinical progression of their prostate cancer with PSA, DRE, mpMRI, and prostate biopsy (systematic and MRI lesion targeted) as follows:
- Initial prostate cancer antigen (PSA) screening with an additional PSA screen every 12 months
- Initial DRE screening with additional DRE to be performed every year that either prostate MRI or biopsy is performed
- Initial mpMRI and prior to each biopsy (i.e., mandated at least every two years until year five, and then every three years thereafter)
- Initial systematic 12-Core prostate biopsy and MRI guided fusion (MRI-US fusion) prostate biopsy of all suspicious lesions (i.e., targeted biopsy). Future biopsies, including 12-core systematic and targeted biopsy (to be performed in the same session) will then be mandated every two years until year five at which time biopsies will be performed every three years thereafter unless contraindicated.
- mpMRI and biopsies may be performed earlier if clinically indicated and will revert back to previous mpMRI/biopsy schedule after.
- Biopsy pathology results will be used as the standard for diagnosis of clinical progression.
- Conditions
- Prostate Cancer
- Being tested
- mpMRI
- Keywords
- Gleason Score, PSA, Progression, Biopsy
- Medical subject headings
- Prostatic Neoplasms, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mpMRIDiagnostic test
3T endorectal coil MR imaging of the prostate gland
| Study group | Role | What they receive |
|---|---|---|
| AS + mpMRI | Experimental | Active surveillance (AS) with the following: a) Initial PSA and DRE screen; then, PSA screening every 12 months, with DRE every year mpMRI or prostate biopsy is performed; b) Initial mpMRI and then prior to all biopsies; c) Initial systemic prostate biopsy and MRI/US fusion-guided prostate biopsy of all suspicious lesions; then, every 2 years for 5 years and then every 3 years Receives: Diagnostic Test: mpMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
role of mpMRI
role of mpMRI in the selection and management of patients for AS by correlating imaging findings with pathological progression as determined on serial biopsies
Measured: beginning of study, prior to all biopsies (i.e., every 2 years until year 5; then, every 3 years after year 5).
correlation of mpMRI, prostate biopsy pathology results, and progression
relationship between mpMRI, prostate biopsy pathology results, and progression in AS patients to determine if prostate biopsies may be safely avoided based on the accuracy of imaging (sensitivity and specificity) to avoid progression
Measured: beginning of study, prior to all biopsies (i.e., every 2 years until year 5; then, every 3 years after year 5).
optimal interval of MR imaging
optimal interval of MR imaging in monitoring AS patients for evidence of progression by correlating sequential MRIs with biopsies with the goal to reduce unnecessary imaging
Measured: beginning of study, prior to all biopsies (i.e., every 2 years until year 5; then, every 3 years after year 5).
Secondary outcomes (1)
prediction of biopsy findings
determine if MR imaging is superior to PSA and digital rectal exam (DRE) in predicting biopsy findings of progression in AS patients
Measured: beginning of study, prior to all biopsies (i.e., every 2 years until year 5; then, every 3 years after year 5).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start18 Nov 2022
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2031 (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 National Cancer Institute (NCI)The 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 508 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Peter A Pinto, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692675
- Sponsor's protocol ID
- 200164
- Other IDs
- 20-C-0164
- Status last verified
- 13 Oct 2026
- First submitted
- 31 Dec 2020
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGAP
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Magnetic Resonance Imaging of the Prostate to Assess Disease Progression and Genomics in Patients Undergoing Active Surveillance for Prostate Cancer
- ClinicalTrials.gov ID
- NCT04692675
- Acronym / sponsor ID
- 200164
- Conditions
- Prostate Cancer
- Keywords
- Gleason Score, PSA, Progression, Biopsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 508 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 5 Jan 2021 (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.
Background:
Active surveillance (AS) is a standard approach to treat low and intermediate risk prostate cancer. For AS, disease progression is monitored. AS uses biopsies, prostate specific antigen (PSA) blood tests, and other tools. Researchers want to see if multiparametric magnetic resonance imaging (mpMRI) can help improve AS.
Objective:
To see if mpMRI can improve how people are monitored during AS.
Eligibility:
Men age 18 and older who have been diagnosed with prostate cancer within the last 2 years.
Design:
Participants will undergo AS. Their PSA level will be checked once a year via blood test. They will have a digital rectal exam once a year.
Participants will have biopsies every 2-3 years. Needles will be put into different parts of the prostate. The needles are guided by ultrasound imaging.
Participants will also have targeted biopsies with mpMRI and MRI guided fusion (MRI-US fusion). MRI-US fusion combines previous MRI images with live ultrasound images. For MRIs, participants will lie on their stomach on the scanner table. A coil may be placed in the rectum.
Participants will have a physical exam and medical record review at least every 3 years. Their weight and vital signs will be checked. They will give data about their daily activities, side effects, and symptoms.
Every 2-3 years, participants will fill out surveys about their prostate health and quality of life.
Participants may give blood, urine, prostate secretion, and saliva samples. The samples will be used for research.
Participation will last for as long as the participant does not need actual treatment for his prostate cancer.
Detailed description
Background:
- Active Surveillance (AS) is a standard approach in the treatment of low and intermediate risk prostate cancer which employs a strategy of monitoring the clinical progression of prostate cancer.
- AS utilizes prostate biopsies, prostate specific antigen (PSA), and digital rectal examinations (DRE) as tools to determine clinical progression in prostate cance
- This protocol aims to assess an additional tool, multiparametric magnetic resonance imaging (mpMRI) to actively visualize and monitor disease within the prostate in addition to standard instruments used to determine clinical progression of disease.
Objectives:
- To determine the role of mpMRI in the selection and management of participants for AS by correlating imaging findings with pathological progression as determined on serial biopsies.
- To determine the optimal interval of MR imaging in monitoring AS participants for evidence of progression by correlating sequential MRIs with biopsies with the goal to reduce unnecessary imaging.
- To evaluate the relationship between mpMRI, prostate biopsy pathology results, and progression in AS participants to determine if prostate biopsies may be safely avoided based on the accuracy of imaging (sensitivity and specificity).
Eligibility:
- Men, 18 years and older with biopsy confirmed prostate cancer
- Gleason Score which less than or equal to 3+4=7
- Initial diagnosis of prostate cancer within 2 years of study entry
- Capable of being consented to the protocol
Design:
- Single arm, prospective, cohort study to correlate mpMRI with prostate biopsy pathology.
- We plan to accrue 508 participants over the entire study period, assuming about a 10% dropout to allow adequate statistical review.
- Participants will be monitored for clinical progression of their prostate cancer with PSA, DRE, mpMRI, and prostate biopsy (systematic and MRI lesion targeted) as follows:
- Initial prostate cancer antigen (PSA) screening with an additional PSA screen every 12 months
- Initial DRE screening with additional DRE to be performed every year that either prostate MRI or biopsy is performed
- Initial mpMRI and prior to each biopsy (i.e., mandated at least every two years until year five, and then every three years thereafter)
- Initial systematic 12-Core prostate biopsy and MRI guided fusion (MRI-US fusion) prostate biopsy of all suspicious lesions (i.e., targeted biopsy). Future biopsies, including 12-core systematic and targeted biopsy (to be performed in the same session) will then be mandated every two years until year five at which time biopsies will be performed every three years thereafter unless contraindicated.
- mpMRI and biopsies may be performed earlier if clinically indicated and will revert back to previous mpMRI/biopsy schedule after.
- Biopsy pathology results will be used as the standard for diagnosis of clinical progression.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AS + mpMRI | Experimental | Diagnostic Test: mpMRIActive surveillance (AS) with the following: a) Initial PSA and DRE screen; then, PSA screening every 12 months, with DRE every year mpMRI or prostate biopsy is performed; b) Initial mpMRI and then prior to all biopsies; c) Initial systemic prostate biopsy and MRI/US fusion-guided prostate biopsy of all suspicious lesions; then, every 2 years for 5 years and then every 3 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must have confirmed histopathological diagnosis of adenocarcinoma of the prostate within 2 years prior to study entry. Pathologic diagnosis must be confirmed by Laboratory of Pathology, NCI. If archival tissue is unavailable or insufficient for this purpose, a fresh biopsy will be collected.
- Biopsy confirmed prostate cancer with Gleason less than or equal to 3+4=7 (primary pattern 3)
- Clinical stage: cT1C or cT2A
- Adult males, greater than or equal to 18 years old
- NOTE: Children are excluded because prostate cancer is not common in pediatric populations. Women are not eligible because this disease occurs only in men.
Key exclusion criteria (11 listed)
- Metastatic prostate cancer/locally advanced disease
- Previous radiation to the pelvis
- Contraindications to prostate biopsy, including:
- Contraindication to mpMRI, including allergy or sensitivity to contrast agents or insufficient renal function to safely tolerate MRI contrast agent
- mpMRI evidence of greater than or equal to T3 disease, including seminal vesicle invasion (SVI), extraprostatic extension (EPE) or locoregional spread of disease
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 |
|---|---|---|
| mpMRI3T endorectal coil MR imaging of the prostate gland | Diagnostic test | AS + mpMRI |
Primary outcome
role of mpMRI
Time frame: beginning of study, prior to all biopsies (i.e., every 2 years until year 5; then, every 3 years after year 5).
role of mpMRI in the selection and management of patients for AS by correlating imaging findings with pathological progression as determined on serial biopsies
correlation of mpMRI, prostate biopsy pathology results, and progression
Time frame: beginning of study, prior to all biopsies (i.e., every 2 years until year 5; then, every 3 years after year 5).
relationship between mpMRI, prostate biopsy pathology results, and progression in AS patients to determine if prostate biopsies may be safely avoided based on the accuracy of imaging (sensitivity and specificity) to avoid progression
optimal interval of MR imaging
Time frame: beginning of study, prior to all biopsies (i.e., every 2 years until year 5; then, every 3 years after year 5).
optimal interval of MR imaging in monitoring AS patients for evidence of progression by correlating sequential MRIs with biopsies with the goal to reduce unnecessary imaging
1 secondary outcome
prediction of biopsy findings
Time frame: beginning of study, prior to all biopsies (i.e., every 2 years until year 5; then, every 3 years after year 5).
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 16 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGAP
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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.
Peter A Pinto, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mpMRI in people with Prostate Cancer, run by National Cancer Institute (NCI) 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 7 inclusion and 11 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 16 Oct 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 Karen K Holcomb ((240) 974-9026, karen.holcomb@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
role of mpMRI (time frame: beginning of study, prior to all biopsies (i.e., every 2 years until year 5; then, every 3 years after year 5).). The study lists 3 primary outcomes in all. 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 16 Oct 2026.