Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05852041
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-05-01
Brief Title:
rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Pilot Study of rhPSMA-PET MRI Imaging for the Detection of Clinically Actionable Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial evaluates whether positron emission tomography-magnetic resonance imaging PET-MRI using the radioactive drug radiohybrid prostate-specific membrane antigen rhPSMA-73 may help in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate cancer who are candidates for active surveillance A PET scan is a test that uses a radioactive drug and a computer to create images of how organs and tissues in the body are functioning The radioactive drug used in this study rhPSMA-73 attaches to the abnormal cells in the body at a different rate than normal cells which allows the scanner to create a detailed picture of how the body is working An MRI scan uses strong magnets and computers to create detailed images of the soft tissue in your body A multiparametric mpMRI is a type of MRI scan that creates a more detailed picture of the prostate gland Using rhPSMA-73 with PET-MRI and mpMRI may be more effective in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate cancer
Detailed Description:
PRIMARY OBJECTIVE
I Measure the rate of rhPSMA-73-PET-MRI identified Gleason Grade Group GG 3-5 disease on pathology or locally advanced disease A threshold rate of 15 detection will be considered clinically significant
SEONDARY OBJECTIVE
I Assessment of safety
EXPLORATORY OBJECTIVES
I Determine the sensitivity specificity positive predictive value PPV and negative predictive value NPV for rhPSMA-PET-MRI to detect prostate cancer in the prostate stratified by Gleason Grade Groups
II Correlate PET MRI findings with surgical specimens for those men who undergo surgical treatment including assessment of pathological stage
III Define whether gene expression of PSMA FOLH1 as defined on the Decipher messenger ribonucleic acid mRNA expression platform relates to signal intensity on PSMA scan
IV Determine whether Decipher genomic classifier scores luminal basal scores or androgen receptor activity scores relate to signal intensity on PSMA scans
OUTLINE
Patients receive rhPSMA-73 intravenously IV then undergo PET-MRI and mpMRI of the prostate on study Patients also undergo Decipher test at screening and MRI-PET prostate biopsy or radical prostatectomy within 90 days per standard of care
I Measure the rate of rhPSMA-73-PET-MRI identified Gleason Grade Group GG 3-5 disease on pathology or locally advanced disease A threshold rate of 15 detection will be considered clinically significant
SEONDARY OBJECTIVE
I Assessment of safety
EXPLORATORY OBJECTIVES
I Determine the sensitivity specificity positive predictive value PPV and negative predictive value NPV for rhPSMA-PET-MRI to detect prostate cancer in the prostate stratified by Gleason Grade Groups
II Correlate PET MRI findings with surgical specimens for those men who undergo surgical treatment including assessment of pathological stage
III Define whether gene expression of PSMA FOLH1 as defined on the Decipher messenger ribonucleic acid mRNA expression platform relates to signal intensity on PSMA scan
IV Determine whether Decipher genomic classifier scores luminal basal scores or androgen receptor activity scores relate to signal intensity on PSMA scans
OUTLINE
Patients receive rhPSMA-73 intravenously IV then undergo PET-MRI and mpMRI of the prostate on study Patients also undergo Decipher test at screening and MRI-PET prostate biopsy or radical prostatectomy within 90 days per standard of care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-02187 | REGISTRY | None | None |
| STU00218970 | None | None | None |
| NU 22U05 | OTHER | None | None |
| P30CA060553 | NIH | Northwestern University | httpsreporternihgovquickSearchP30CA060553 |