rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance
Northwestern University · with National Cancer Institute (NCI) · NCT05852041
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · Men only
- Healthy volunteers
- Accepted
- Study type
- Interventional · Early Phase 1
- Target enrollment
- 40
- US sites recruiting
- 1
- Study start
- June 7, 2023
- Record last updated
- July 2, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Biopsy of Prostate; Decipher Prostate Cancer Test; Flotufolastat F-18 Gallium; Magnetic Resonance Imaging; Multiparametric Magnetic Resonance Imaging; Positron Emission Tomography; Radical Prostatectomy
Conditions: Prostate Adenocarcinoma; Stage I Prostate Cancer AJCC v8; Stage IIA Prostate Cancer AJCC v8; Stage IIB Prostate Cancer AJCC v8
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
Northwestern University
Chicago, IL 60611
Site contact: Ashley E. Ross · 312-694-9001 · Ashley.ross@nm.org
Study contacts (from the official record)
- Sophia Kallas · 312-694-9001 · sophia.kallas@northwestern.edu
- Nikki Hubbard · 3126-694-9001 · nikki.hubbard@northwestern.edu
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