Recruiting

Prostate Cancer

Sponsor:

National Cancer Institute (NCI)

Code:

NCT04692675

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

mpMRI

Study Details

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

Study ID

NCT04692675

Start date

Nov 18, 2022

Status verified date

Jun 26, 2026

Completion date

Sep 1, 2031

Anticipated

Primary completion date

Sep 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA:
  • 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

EXCLUSION CRITERIA:

  • 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

Study Design

Enrollment

508 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: AS + mpMRI

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

Interventions

mpMRI

3T endorectal coil MR imaging of the prostate gland

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). ]
  • 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). ]
  • 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). ]

Central Contacts and Locations

Central contacts

Karen K Holcomb

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

Peter A Pinto, M.D.

(240) 858-3700pp173u@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

888-624-1937

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Aug 27, 2026

Last verified

Jun 26, 2026

Keywords

  • Gleason Score
  • PSA
  • Progression
  • Biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-08-27.