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Multiparametric MRI for Prostate Cancer Active Surveillance

This study is looking at how a special type of MRI, called multiparametric magnetic resonance imaging (mpMRI), can help monitor prostate cancer in men who are on active surveillance. Active surveillance means closely watching the cancer without immediate treatment. Researchers want to see if mpMRI can improve how doctors track the cancer's progression, potentially reducing the need for frequent biopsies. You might be able to join if you are a man aged 18 or older and were diagnosed with prostate cancer within the last two years. The study aims to understand the best way to use mpMRI and how it compares to standard monitoring methods like biopsies and PSA (prostate specific antigen) blood tests. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 508 participants. It is not specified if it is randomized or blinded.
What's involved
You will undergo active surveillance, which includes annual PSA blood tests and digital rectal exams. You will also have biopsies every 2-3 years, and mpMRI scans at the beginning of the study and then every 2-3 years.
Compensation
Not stated in the trial record.
Follow-up
The study will assess the role of mpMRI, correlation with biopsies, and optimal imaging interval at the beginning of the study, then every 2 years until year 5, and every 3 years after year 5.

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NCT04692675

Multiparametric Magnetic Resonance Imaging of the Prostate to Assess Disease Progression and Genomics in Patients Undergoing Active Surveillance for Prostate Cancer

Recruiting
NAAges 18+Interventional
National Cancer Institute (NCI)
~508 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:mpMRI

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
role of mpMRI
Measured over beginning of study, prior to all biopsies (i.e., every 2 years until year 5; then, every 3 years after year 5).
+2 more outcomes measured

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Peter A Pinto, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Karen K Holcomb
[email protected]
(240) 974-9026
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

Exclusion

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
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

What this trial measures

  • role of mpMRIbeginning 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 progressionbeginning 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 imagingbeginning 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