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rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance

Primary Purpose

Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Biopsy of Prostate
Decipher Prostate Cancer Test
Flotufolastat F-18 Gallium
Magnetic Resonance Imaging
Multiparametric Magnetic Resonance Imaging
Positron Emission Tomography
Radical Prostatectomy
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Northwestern UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (rhPSMA, PET-MRI, mpMRI)

Arm Description

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.

Outcomes

Primary Outcome Measures

Radio-pathological correlation between positron emession tomography-magnetic resonance imaging (PET-MRI) and prostate biopsy or radical prostatectomy
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.

Secondary Outcome Measures

Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
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.

Full Information

First Posted
May 1, 2023
Last Updated
September 29, 2023
Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05852041
Brief Title
rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2023 (Actual)
Primary Completion Date
June 7, 2027 (Anticipated)
Study Completion Date
June 7, 2035 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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)-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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
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.
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (rhPSMA, PET-MRI, mpMRI)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Biopsy of Prostate
Other Intervention Name(s)
Prostate Biopsy, Prostatic Biopsy
Intervention Description
Undergo MRI/PET prostate biopsy
Intervention Type
Genetic
Intervention Name(s)
Decipher Prostate Cancer Test
Other Intervention Name(s)
Decipher, Decipher Metastasis Test, Decipher Test
Intervention Description
Undergo decipher
Intervention Type
Other
Intervention Name(s)
Flotufolastat F-18 Gallium
Other Intervention Name(s)
(18F)-rhPSMA-7.3, 18F-rhPSMA-7.3, 18FrhPSMA-7.3, F-18-rhPSMA-7.3, Fluorine F 18 radiohybrid PSMA-7.3, Fluorine F 18 rhPSMA-7.3, Fluorine-18 rhPSMA-7.3, rhPSMA-7.3 (18F)
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Intervention Description
Undergo PET-MRI
Intervention Type
Procedure
Intervention Name(s)
Multiparametric Magnetic Resonance Imaging
Other Intervention Name(s)
MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRI
Intervention Description
Undergo mpMRI
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT
Intervention Description
Undergo PET-MRI
Intervention Type
Procedure
Intervention Name(s)
Radical Prostatectomy
Other Intervention Name(s)
Prostatovesiculectomy
Intervention Description
Undergo radical prostatectomy
Primary Outcome Measure Information:
Title
Radio-pathological correlation between positron emession tomography-magnetic resonance imaging (PET-MRI) and prostate biopsy or radical prostatectomy
Description
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.
Time Frame
Up to 90 days
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Description
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.
Time Frame
Within 24 hours of radio-tracer injection

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nikki Hubbard
Phone
312-694-9001
Email
nikki.hubbard@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley E Ross
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley E. Ross
Phone
312-694-9001
Email
Ashley.ross@nm.org
First Name & Middle Initial & Last Name & Degree
Ashley E. Ross

12. IPD Sharing Statement

Learn more about this trial

rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance

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