Clinical trial · Interventional
rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage IIA Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy of Prostate | Procedure | — | UNRESOLVED |
| Decipher Prostate Cancer Test | Genetic | — | UNRESOLVED |
| Flotufolastat F-18 Gallium | Other | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Multiparametric Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
| Radical Prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (rhPSMA, PET-MRI, mpMRI)
- description
- 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.
- interventionNames
- 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
Primary outcomes (1)
- measure
- Radio-pathological correlation between positron emession tomography-magnetic resonance imaging (PET-MRI) and prostate biopsy or radical prostatectomy
- timeFrame
- Up to 90 days
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDAlam 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. PMID 41833067
- DERIVEDJang 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 40177325