Multiparametric Magnetic Resonance Imaging of the Prostate to Assess Disease Progression and Genomics in Patients Undergoing Active Surveillance for Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT04692675|
Recruitment Status : Not yet recruiting
First Posted : January 5, 2021
Last Update Posted : March 8, 2021
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.
To see if mpMRI can improve how people are monitored during AS.
Men age 18 and older who have been diagnosed with prostate cancer within the last 2 years.
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Diagnostic Test: mpMRI||Not Applicable|
- Active Surveillance (AS) is a standard approach in the treatment of low and intermediate risk prostate cancer which employs a strategy of monitoring the clinical progression of prostate cancer.
- AS utilizes prostate biopsies, prostate specific antigen (PSA), and digital rectal examinations (DRE) as tools to determine clinical progression in prostate cance
- This protocol aims to assess an additional tool, multiparametric magnetic resonance imaging (mpMRI) to actively visualize and monitor disease within the prostate in addition to standard instruments used to determine clinical progression of disease.
- To determine the role of mpMRI in the selection and management of participants for AS by correlating imaging findings with pathological progression as determined on serial biopsies.
- To determine the optimal interval of MR imaging in monitoring AS participants for evidence of progression by correlating sequential MRIs with biopsies with the goal to reduce unnecessary imaging.
- To evaluate the relationship between mpMRI, prostate biopsy pathology results, and progression in AS participants to determine if prostate biopsies may be safely avoided based on the accuracy of imaging (sensitivity and specificity).
- Men, 18 years and older with biopsy confirmed prostate cancer
- Gleason Score which less than or equal to 3+4=7
- Initial diagnosis of prostate cancer within 2 years of study entry
- Capable of being consented to the protocol
- Single arm, prospective, cohort study to correlate mpMRI with prostate biopsy pathology.
- We plan to accrue 508 participants over the entire study period, assuming about a 10% dropout to allow adequate statistical review.
Participants will be monitored for clinical progression of their prostate cancer with PSA, DRE, mpMRI, and prostate biopsy (systematic and MRI lesion targeted) as follows:
- Initial prostate cancer antigen (PSA) screening with an additional PSA screen every 12 months
- Initial DRE screening with additional DRE to be performed every year that either prostate MRI or biopsy is performed
- Initial mpMRI and prior to each biopsy (i.e., mandated at least every two years until year five, and then every three years thereafter)
- Initial systematic 12-Core prostate biopsy and MRI guided fusion (MRI-US fusion) prostate biopsy of all suspicious lesions (i.e., targeted biopsy). Future biopsies, including 12-core systematic and targeted biopsy (to be performed in the same session) will then be mandated every two years until year five at which time biopsies will be performed every three years thereafter unless contraindicated.
- mpMRI and biopsies may be performed earlier if clinically indicated and will revert back to previous mpMRI/biopsy schedule after.
- Biopsy pathology results will be used as the standard for diagnosis of clinical progression.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||508 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multiparametric Magnetic Resonance Imaging of the Prostate to Assess Selection and Disease Progression in Patients Undergoing Active Surveillance for Prostate Cancer|
|Estimated Study Start Date :||March 11, 2021|
|Estimated Primary Completion Date :||September 1, 2025|
|Estimated Study Completion Date :||September 1, 2027|
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
Diagnostic Test: mpMRI
3T endorectal coil MR imaging of the prostate gland
- 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). ]role of mpMRI in the selection and management of patients for AS by correlating imaging findings with pathological progression as determined on serial biopsies
- 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). ]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
- 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). ]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
- prediction of biopsy findings [ Time Frame: beginning of study, prior to all biopsies (i.e., every 2 years until year 5; then, every 3 years after year 5). ]determine if MR imaging is superior to PSA and digital rectal exam (DRE) in predicting biopsy findings of progression in AS patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04692675
|Contact: Michele L Reed (Diffenderfer), R.N.||(240) 760-6121||NCIMO_Referrals@mail.nih.gov|
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Peter A Pinto, M.D.||National Cancer Institute (NCI)|