Recruiting
Early Phase 1

rhPSMA-73

Sponsor:

Northwestern University

Code:

NCT05852041

Conditions

Prostate Adenocarcinoma

Stage I Prostate Cancer AJCC v8

Stage IIA Prostate Cancer AJCC v8

Stage IIB Prostate Cancer AJCC v8

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

Biopsy of Prostate

Decipher Prostate Cancer Test

Flotufolastat F-18 Gallium

Magnetic Resonance Imaging

Multiparametric Magnetic Resonance Imaging

Study Details

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.

Conditions

Prostate Adenocarcinoma

Stage I Prostate Cancer AJCC v8

Stage IIA Prostate Cancer AJCC v8

Stage IIB Prostate Cancer AJCC v8

Study ID

NCT05852041

Start date

Jun 7, 2023

Status verified date

Jun, 2026

Completion date

Jun 7, 2035

Anticipated

Primary completion date

May 13, 2026

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

Biopsy of Prostate

Undergo MRI/PET prostate biopsy

Decipher Prostate Cancer Test

Undergo decipher

Flotufolastat F-18 Gallium

Given IV

Magnetic Resonance Imaging

Undergo PET-MRI

Multiparametric Magnetic Resonance Imaging

Undergo mpMRI

Positron Emission Tomography

Undergo PET-MRI

Radical Prostatectomy

Undergo radical prostatectomy

Primary outcome measure

  • Radio-pathological correlation between positron emession tomography-magnetic resonance imaging (PET-MRI) and prostate biopsy or radical prostatectomy [ Time Frame: Up to 90 days ]

Central Contacts and Locations

Central contacts

Sophia Kallas

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

Nikki Hubbard

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

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Ashley E. Ross

312-694-9001Ashley.ross@nm.org

Principal Investigator:

Ashley E. Ross

More Information

Sponsor

Northwestern University

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-07-02.