- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05852041
rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance
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
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVE:
I. Measure the rate of rhPSMA-7.3-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-7.3 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 Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Nikki Hubbard
- Phone Number: 312-694-9001
- Email: nikki.hubbard@northwestern.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University
-
Contact:
- Ashley E. Ross
- Phone Number: 312-694-9001
- Email: Ashley.ross@nm.org
-
Principal Investigator:
- Ashley E. Ross
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy men (Eastern Cooperative Oncology Group [ECOG] 0-1), >= 18 years old with at least 10 year life expectancy
- Histologically proven Gleason Grade Group 1 or 2 adenocarcinoma of the prostate
- Last prostate cancer containing biopsy performed within 3-15 months (mo.) prior to screening. Biopsy must have been >= 10 core biopsy and informed by prior mpMRI
- Prostate cancer categorized as low risk or favorable risk by National Comprehensive Cancer Network (NCCN) criteria (low risk is defined as T1c-T2a, prostate-specific antigen [PSA] < 10ng/ml, Gleason Grade Group 1 [Gleason 3+3=6] disease) and favorable intermediate risk as having no more than one of the following intermediate risk features, clinical T2b-T2c disease, PSA 10-20ng/ml, Gleason Grade Group 2 [Gleason score 3+4=7])
- Decipher genomic classifier score from prior biopsy >= 0.45
- Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures
- Concurrent diseases and malignancies are permitted
- Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on the study
- Willing to undergo prostate biopsy prior to non-surgical treatment of prostate cancer and within 90 days of PET-MRI imaging
Exclusion Criteria:
- Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer
- NCCN very low risk category (T1c and Gleason Grade Group 1 [Gleason score 3+3=6], PSA < 10 ng/mL, fewer than 3 prostate biopsy cores positive, =< 50% cancer in any core, PSA density < 0.15 ng/mL/g)
- Decipher score < 0.45
- Prior bladder outlet procedure (i.e,. holmium laser enucleation of the prostate [HoLEP], transurethral resection of the prostate [TURP], Urolift, Rezum)
- Prohibited medications: use of 5 alpha reductase inhibitor or androgen deprivation therapy (i.e., leuprolide, relugolix) within 1 month of screening
- Contra-indication or relative contra-indication to MRI (i.e., pacemaker)
- History of hip replacement
- Subject has received investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (rhPSMA, PET-MRI, mpMRI)
Patients receive rhPSMA-7.3
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.
|
Undergo mpMRI
Other Names:
Undergo radical prostatectomy
Other Names:
Undergo PET-MRI
Other Names:
Undergo PET-MRI
Other Names:
Undergo MRI/PET prostate biopsy
Other Names:
Undergo decipher
Other Names:
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radio-pathological correlation between positron emession tomography-magnetic resonance imaging (PET-MRI) and prostate biopsy or radical prostatectomy
Time Frame: Up to 90 days
|
Will report agreement between pathology and imaging and ability of radiohybrid prostate-specific membrane antigen-7-PET-MRI to identify higher grade and stage disease as a raw percentage.
|
Up to 90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Time Frame: Within 24 hours of radio-tracer injection
|
Occurrence of severe adverse events occurring following imaging will be reported as a percentage.
Will use the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
|
Within 24 hours of radio-tracer injection
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ashley E Ross, Northwestern University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NU 22U05 (Other Identifier: Northwestern University)
- P30CA060553 (U.S. NIH Grant/Contract)
- NCI-2023-02187 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- STU00218970
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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