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

NCT04692675 | Recruiting

• 2 other identifiers: 20016420-C-0164
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prostate Cancer

Keywords

Gleason Score; PSA; Progression; Biopsy

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  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

  beginning of study, prior to all biopsies (i.e., every 2 years until year 5; then, every 3 years after year 5).

Study Arms (1)

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

Diagnostic Test: mpMRI

Interventions

mpMRI DIAGNOSTIC_TEST

3T endorectal coil MR imaging of the prostate gland

AS + mpMRI

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Prostatic Neoplasms; Disease Progression

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Peter A Pinto, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen K Holcomb

CONTACT

(240) 974-9026; karen.holcomb@nih.gov

Peter A Pinto, M.D.

CONTACT

(240) 858-3700; pp173u@nih.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2020
• First Posted: January 5, 2021
• Study Start: November 18, 2022
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2031
• Last Updated: May 6, 2026

Record last verified: 2026-05-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@ Genomic data are made available via dbGaP through requests to the data custodians.

Locations

US (1)