Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04692675
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2020-12-31
Brief Title:
Multiparametric Magnetic Resonance Imaging of the Prostate to Assess Disease Progression and Genomics in Patients Undergoing Active Surveillance for Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Multiparametric Magnetic Resonance Imaging of the Prostate to Assess Disease Progression and Genomics in Patients Undergoing Active Surveillance for Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-09-26
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Background
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
Objectives
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
Eligibility
Men 18 years and older with biopsy confirmed prostate cancer
Gleason Score which less than or equal to 347
Initial diagnosis of prostate cancer within 2 years of study entry
Capable of being consented to the protocol
Design
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 ie 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 ie 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 mpMRIbiopsy schedule after
Biopsy pathology results will be used as the standard for diagnosis of clinical progression
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
Objectives
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
Eligibility
Men 18 years and older with biopsy confirmed prostate cancer
Gleason Score which less than or equal to 347
Initial diagnosis of prostate cancer within 2 years of study entry
Capable of being consented to the protocol
Design
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 ie 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 ie 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 mpMRIbiopsy schedule after
Biopsy pathology results will be used as the standard for diagnosis of clinical progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20-C-0164 | None | None | None |