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

Official record

Identifier

NCT04692675

Recruiting locations

country

United States

Interventions studied

mpMRI

Lead sponsor

National Cancer Institute (NCI)

Target enrolment

508 participants

Study type

INTERVENTIONAL

Phase

Not applicable

Status

Recruiting

First posted

Jan 5, 2021

Last updated on the registry

Aug 27, 2026

Age

18 Years

Sex

MALE

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

* 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

Indexed under

Prostate Cancer