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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT05852041
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

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 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Biopsy of Prostate — PROCEDURE
    Undergo MRI/PET prostate biopsy
  • Decipher Prostate Cancer Test — GENETIC
    Undergo decipher
  • Flotufolastat F-18 Gallium — OTHER
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo PET-MRI
  • Multiparametric Magnetic Resonance Imaging — PROCEDURE
    Undergo mpMRI
  • Positron Emission Tomography — PROCEDURE
    Undergo PET-MRI
  • Radical Prostatectomy — PROCEDURE
    Undergo radical prostatectomy

Study Details

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.

Key Dates

Start date
Jun 7, 2023
Status verified
May 2025
Primary completion
Jun 7, 2027
Completion
Jun 7, 2035

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Ashley E. Ross
[email protected]
312-694-9001
Ashley E. Ross (PRINCIPAL_INVESTIGATOR)

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By research site
Northwestern University· Chicago, IL

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