Using advanced MRI to monitor prostate cancer in men on active surveillance
Multiparametric Magnetic Resonance Imaging of the Prostate to Assess Disease Progression and Genomics in Patients Undergoing Active Surveillance for Prostate Cancer
NA · National Institutes of Health Clinical Center (CC) · NCT04692675
This study is testing if advanced MRI can help men with low to intermediate risk prostate cancer on active surveillance better track their disease and possibly avoid unnecessary biopsies.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 508 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Drugs / interventions | radiation |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT04692675 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of multiparametric magnetic resonance imaging (mpMRI) in monitoring disease progression in men diagnosed with low to intermediate risk prostate cancer who are undergoing active surveillance. Participants will have their prostate cancer monitored through standard methods such as PSA blood tests and biopsies, while also incorporating mpMRI to visualize the disease. The goal is to determine if mpMRI can provide more accurate assessments of disease progression and potentially reduce the need for invasive biopsies. The study will correlate imaging findings with biopsy results to optimize monitoring intervals and improve patient management.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older who have been diagnosed with prostate cancer within the last two years and have a Gleason Score of 7 or lower.
Not a fit: Patients with advanced prostate cancer or those who do not meet the eligibility criteria, such as women or children, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate monitoring of prostate cancer, reducing unnecessary biopsies and improving patient outcomes.
How similar studies have performed: Other studies have shown promising results using mpMRI for monitoring prostate cancer, indicating that this approach may enhance current practices.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Peter A Pinto, M.D. — National Cancer Institute (NCI)
- Study coordinator: Karen K Holcomb
- Email: karen.holcomb@nih.gov
- Phone: (240) 974-9026
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Gleason Score, PSA, Progression, Biopsy