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mpMRI Monitoring for Prostate Cancer

N/A
Recruiting
Led By Peter A Pinto, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult males, greater than or equal to 18 years old
Biopsy confirmed prostate cancer with Gleason less than or equal to 3+4=7 (primary pattern 3)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up beginning of study, prior to all biopsies (i.e., every 2 years until year 5; then, every 3 years after year 5).
Awards & highlights

Study Summary

This trial is testing if multiparametric magnetic resonance imaging (mpMRI) can help improve active surveillance (AS) for low and intermediate risk prostate cancer. AS uses biopsies, prostate specific antigen (PSA) blood tests, and other tools to monitor disease progression.

Who is the study for?
Men over 18 with prostate cancer diagnosed within the last two years, who have chosen active surveillance and meet specific health criteria. They must not have advanced disease, prior pelvic radiation or surgeries that affect imaging or biopsy accuracy, severe bleeding disorders, extreme immunocompromise, contraindications to mpMRI including allergies to contrast agents or poor kidney function.Check my eligibility
What is being tested?
The trial is testing if multiparametric magnetic resonance imaging (mpMRI) can better monitor disease progression in men undergoing active surveillance for low and intermediate risk prostate cancer. It involves regular PSA tests, biopsies guided by ultrasound and mpMRI technology, physical exams and questionnaires about quality of life.See study design
What are the potential side effects?
Potential side effects may include discomfort from the MRI procedure especially if a coil is placed in the rectum during scans. Biopsy procedures could cause pain, bleeding or infection at the needle insertion sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man and I am 18 years old or older.
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My prostate cancer has a Gleason score of 7 or less, with a primary pattern of 3.
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My prostate cancer was confirmed by a biopsy within the last 2 years.
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My breast cancer is at an early stage, not very large or spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~beginning of study, prior to all biopsies (i.e., every 2 years until year 5; then, every 3 years after year 5).
This trial's timeline: 3 weeks for screening, Varies for treatment, and beginning of study, prior to all biopsies (i.e., every 2 years until year 5; then, every 3 years after year 5). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biopsy
optimal interval of MR imaging
role of mpMRI
Secondary outcome measures
Biopsy

Trial Design

1Treatment groups
Experimental Treatment
Group I: AS + mpMRIExperimental Treatment1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mpMRI
2014
N/A
~370

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,926,839 Total Patients Enrolled
560 Trials studying Prostate Cancer
506,663 Patients Enrolled for Prostate Cancer
Peter A Pinto, M.D.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
3,298 Total Patients Enrolled
5 Trials studying Prostate Cancer
3,298 Patients Enrolled for Prostate Cancer

Media Library

mpMRI Clinical Trial Eligibility Overview. Trial Name: NCT04692675 — N/A
Prostate Cancer Research Study Groups: AS + mpMRI
Prostate Cancer Clinical Trial 2023: mpMRI Highlights & Side Effects. Trial Name: NCT04692675 — N/A
mpMRI 2023 Treatment Timeline for Medical Study. Trial Name: NCT04692675 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are involved in this experiment?

"Affirmative. Clinicaltrials.gov displays that this clinical trial, which was introduced on November 18th 2022, is currently accepting applicants. In total, 508 subjects are expected to be enrolled from one medical center."

Answered by AI

Is this research endeavor currently enrolling participants?

"Indeed, the information from clinicaltrials.gov reports that this medical trial is actively seeking volunteers to participate. The study was first published on November 18th 2022 and has since been updated in December 1st 2022. Currently, 508 patients are being recruited at a single site for further evaluation."

Answered by AI
~262 spots leftby Sep 2025