NCT05852041

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
110mo left

Started Jun 2023

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Jun 2023Jun 2035

First Submitted

Initial submission to the registry

May 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
28 days until next milestone

Study Start

First participant enrolled

June 7, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2027

Expected
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2035

Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

4 years

First QC Date

May 1, 2023

Last Update Submit

May 19, 2025

Conditions

Prostate AdenocarcinomaStage I Prostate Cancer AJCC v8Stage IIA Prostate Cancer AJCC v8Stage IIB Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 90 days

Secondary Outcomes (1)

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

    Within 24 hours of radio-tracer injection

Study Arms (1)

Treatment (rhPSMA, PET-MRI, mpMRI)

EXPERIMENTAL

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.

Procedure: Biopsy of ProstateGenetic: Decipher Prostate Cancer TestOther: Flotufolastat F-18 GalliumProcedure: Magnetic Resonance ImagingProcedure: Multiparametric Magnetic Resonance ImagingProcedure: Positron Emission TomographyProcedure: Radical Prostatectomy

Interventions

Biopsy of ProstatePROCEDURE

Undergo MRI/PET prostate biopsy

Also known as: Prostate Biopsy, Prostatic Biopsy
Treatment (rhPSMA, PET-MRI, mpMRI)
Decipher Prostate Cancer TestGENETIC

Undergo decipher

Also known as: Decipher, Decipher Metastasis Test, Decipher Test
Treatment (rhPSMA, PET-MRI, mpMRI)
Flotufolastat F-18 GalliumOTHER

Given IV

Also known as: (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)
Treatment (rhPSMA, PET-MRI, mpMRI)
Magnetic Resonance ImagingPROCEDURE

Undergo PET-MRI

Also known as: 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
Treatment (rhPSMA, PET-MRI, mpMRI)
Multiparametric Magnetic Resonance ImagingPROCEDURE

Undergo mpMRI

Also known as: MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRI
Treatment (rhPSMA, PET-MRI, mpMRI)
Positron Emission TomographyPROCEDURE

Undergo PET-MRI

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT
Treatment (rhPSMA, PET-MRI, mpMRI)
Radical ProstatectomyPROCEDURE

Undergo radical prostatectomy

Also known as: Prostatovesiculectomy
Treatment (rhPSMA, PET-MRI, mpMRI)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (1)

  • Jang JW, Abrams A, Jawahar A, Savas H, Yang XJ, Mehta V, Schnauss M, Schaeffer EM, Alam R, Ross AE. Detection of MRI-Invisible Disease Using PSMA PET/CT in a Patient Considering Focal Therapy. Case Rep Urol. 2025 Mar 26;2025:2981515. doi: 10.1155/criu/2981515. eCollection 2025.

    PMID: 40177325DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Ashley E Ross

    Northwestern University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophia Kallas

CONTACT

312-694-9001sophia.kallas@northwestern.edu

Nikki Hubbard

CONTACT

3126-694-9001nikki.hubbard@northwestern.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Masking Details
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.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Urology

Study Record Dates

First Submitted

May 1, 2023

First Posted

May 10, 2023

Study Start

June 7, 2023

Primary Completion (Estimated)

June 7, 2027

Study Completion (Estimated)

June 7, 2035

Last Updated

May 22, 2025

Record last verified: 2025-05

Locations

US(1)