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Prostate AdenocarcinomaEarly Phase 1NCT05852041

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

A Early Phase 1 study testing Biopsy of Prostate, Decipher Prostate Cancer Test and Flotufolastat F-18 Gallium in people with Prostate Adenocarcinoma and Stage I Prostate Cancer AJCC v8, run by Northwestern University at 1 site in United States.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
What is being tested?
Biopsy of Prostate, Decipher Prostate Cancer Test and Flotufolastat F-18 Gallium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
7 Jun 2023to 7 Jun 2035
Phase
Early Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sophia Kallas contact

312-694-9001

sophia.kallas@northwestern.edu

Nikki Hubbard contact

3126-694-9001

nikki.hubbard@northwestern.edu

United States1 site, 1 recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Ashley E. Ross, 312-694-9001, Ashley.ross@nm.org

    Ashley E. Ross

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. Assessment of safety.

EXPLORATORY OBJECTIVES:

  1. 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.

Being tested
Biopsy of Prostate, Decipher Prostate Cancer Test, Flotufolastat F-18 Gallium, Magnetic Resonance Imaging, Multiparametric Magnetic Resonance Imaging
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biopsy of ProstateProcedure or surgery

    Also called Prostate Biopsy, Prostatic Biopsy

    Undergo MRI/PET prostate biopsy

  • Decipher Prostate Cancer TestGenetic

    Also called Decipher, Decipher Metastasis Test, Decipher Test

    Undergo decipher

  • Flotufolastat F-18 GalliumOther

    Also called (18F)-rhPSMA-7.3, 18F-rhPSMA-7.3, 18FrhPSMA-7.3, F-18-rhPSMA-7.3

    Given IV

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR

    Undergo PET-MRI

  • Multiparametric Magnetic Resonance ImagingProcedure or surgery

    Also called MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRI

    Undergo mpMRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

    Undergo PET-MRI

  • Radical ProstatectomyProcedure or surgery

    Also called Prostatovesiculectomy

    Undergo radical prostatectomy

Study groups in NCT05852041
Study groupRoleWhat they receive
Treatment (rhPSMA, PET-MRI, mpMRI)ExperimentalPatients 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.
Receives: Procedure: Biopsy of Prostate; Genetic: Decipher Prostate Cancer Test; Other: Flotufolastat F-18 Gallium; Procedure: Magnetic Resonance Imaging; Procedure: Multiparametric Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Procedure: Radical Prostatectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 90 days

Secondary outcomes (1)

  1. 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.

    Measured: Within 24 hours of radio-tracer injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2023
  2. Study start7 Jun 2023
  3. Primary completion13 May 2026
  4. Study completion7 Jun 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05852041
Sponsor's protocol ID
NU 22U05
Other IDs
NCI-2023-02187, STU00218970, NU 22U05, P30CA060553
Status last verified
Jun 2026
First submitted
1 May 2023
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Alam R, Hesse D, Hubbard N, McGarrity E, Kumar S, Neill C, Li Y, Handa N, Patel HD, Schaeffer EM, Savas H, Ross AE. A Pilot Study of 18F-rhPSMA-7.3-PET/MRI to Reduce Mischaracterization of Active Surveillance and Focal Therapy Candidates With Occult Higher Risk Disease. Prostate. 2026 Jun;86(8):865-871. doi: 10.1002/pros.70147. Epub 2026 Mar 15.

    PubMed 41833067

  • 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.

    PubMed 40177325

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