Trial Title:
rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance
NCT ID:
NCT05852041
Condition:
Prostate Adenocarcinoma
Stage I Prostate Cancer AJCC v8
Stage IIA Prostate Cancer AJCC v8
Stage IIB Prostate Cancer AJCC v8
Conditions: Official terms:
Prostatic Neoplasms
Fluorides
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Masking description:
A read will completed for the PET portion of the examination by a nuclear medicine
trained radiologist who is blinded to the mpMRI portion of the exam.
Intervention:
Intervention type:
Procedure
Intervention name:
Biopsy of Prostate
Description:
Undergo MRI/PET prostate biopsy
Arm group label:
Treatment (rhPSMA, PET-MRI, mpMRI)
Other name:
Prostate Biopsy
Other name:
Prostatic Biopsy
Intervention type:
Genetic
Intervention name:
Decipher Prostate Cancer Test
Description:
Undergo decipher
Arm group label:
Treatment (rhPSMA, PET-MRI, mpMRI)
Other name:
Decipher
Other name:
Decipher Metastasis Test
Other name:
Decipher Test
Intervention type:
Other
Intervention name:
Flotufolastat F-18 Gallium
Description:
Given IV
Arm group label:
Treatment (rhPSMA, PET-MRI, mpMRI)
Other name:
(18F)-rhPSMA-7.3
Other name:
18F-rhPSMA-7.3
Other name:
18FrhPSMA-7.3
Other name:
F-18-rhPSMA-7.3
Other name:
Fluorine F 18 radiohybrid PSMA-7.3
Other name:
Fluorine F 18 rhPSMA-7.3
Other name:
Fluorine-18 rhPSMA-7.3
Other name:
rhPSMA-7.3 (18F)
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo PET-MRI
Arm group label:
Treatment (rhPSMA, PET-MRI, mpMRI)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Intervention type:
Procedure
Intervention name:
Multiparametric Magnetic Resonance Imaging
Description:
Undergo mpMRI
Arm group label:
Treatment (rhPSMA, PET-MRI, mpMRI)
Other name:
MP-MRI
Other name:
mpMRI
Other name:
Multi-parametric MRI
Other name:
Multiparametric MRI
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET-MRI
Arm group label:
Treatment (rhPSMA, PET-MRI, mpMRI)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Procedure
Intervention name:
Radical Prostatectomy
Description:
Undergo radical prostatectomy
Arm group label:
Treatment (rhPSMA, PET-MRI, mpMRI)
Other name:
Prostatovesiculectomy
Summary:
This clinical trial evaluates whether positron emission tomography-magnetic resonance
imaging (PET-MRI) using the radioactive drug radiohybrid prostate-specific membrane
antigen (rhPSMA)-7.3 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-7.3, 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 (mp)MRI 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-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.
Criteria for eligibility:
Criteria:
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashley E. Ross
Phone:
312-694-9001
Email:
Ashley.ross@nm.org
Investigator:
Last name:
Ashley E. Ross
Email:
Principal Investigator
Start date:
June 7, 2023
Completion date:
June 7, 2035
Lead sponsor:
Agency:
Northwestern University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Northwestern University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05852041
