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18F-rhPSMA-7.3 PET/MRI for High-Risk Prostate Cancer

This study is looking at how well a special imaging scan, called 18F-rhPSMA-7.3 PET/MRI, can find if prostate cancer has spread to the lymph nodes in men with high-risk localized prostate cancer. This scan uses a substance called flotufolastat F-18 gallium (18F-rhPSMA-7.3) to help doctors see the cancer better. The goal is to see how accurately this scan can predict lymph node metastasis (when cancer spreads to nearby lymph nodes) before surgery. You may be able to join if you are a man between 30 and 85 years old with a new diagnosis of high-risk prostate cancer that hasn't spread to other parts of your body, and you are scheduled for surgery to remove your prostate and lymph nodes. The study will measure the scan's ability to correctly identify lymph node metastasis within 12 months.

Study design
This is an interventional study planning to enroll 50 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive an intravenous (IV) injection of 18F-rhPSMA-7.3 and undergo a PET/MRI scan up to 30 days before your prostate surgery. You would also have a CT/MRI or bone scan/PET, and tissue collected during screening.
Compensation
Not stated in the trial record.
Follow-up
You would be followed up at 6 weeks, 3 months, 9 months, and 12 months after your surgery.

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NCT06389786

Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer

Recruiting
NAAges 30–85InterventionalScreening
Mayo Clinic
~50 participants
Updated 2026-04-06 on ClinicalTrials.gov
What's tested:Bilateral Pelvic Lymph Node DissectionBiospecimen CollectionBone ScanComputed TomographyElectronic Health Record ReviewFlotufolastat F-18 Gallium

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity of flotufolastat F-18 gallium (18F-rhPSMA-7.3) positron emission tomography (PET)/magnetic resonance (MRI) for the detection of lymph node metastasis
Measured over Up to 12 months

Conditions

Localized Prostate Carcinoma
Oligometastatic Prostate Carcinoma
Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8

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Prostate Carcinoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Ram A. Pathak, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Eligibility criteria

Inclusion

Male subjects ≥ 30 and ≤ 85 years old
Primary diagnosis of prostate cancer selected for surgical intervention (radical prostatectomy with extended lymph node dissection)
Primary diagnosis of untreated American Urological Association (AUA) guidelines high-risk localized prostate cancer, hormone-naïve prostate cancer via contrast enhanced prostate MRI + tissue sampling
Planned elective radical prostatectomy with extended pelvic lymph node dissection
Clinical oligometastatic disease with ≤ 3 nodes positive on preoperative standard of care imaging of prostate region within 6 months of surgery
Patient agrees to comply with the investigator instructions
Patient agrees to comply with the follow-up surveillance schedule
Have ability to provide full written consent

Exclusion

High-risk cancer planned for neoadjuvant therapy
Patients with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study
Patients that have had prior hormonal therapy such as Lupron or oral antiandrogens ≤ 12 weeks prior to registration
Clinical oligometastatic disease with \> 3 nodes positive preoperative standard of care imaging of prostate region
Previous history of pelvic radiation
Patients with obesity defined as body mass index (BMI) \> 40 kg/m\^2
History of prior laparoscopic inguinal hernia repair with mesh
Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period
Inability to lie still for 75 minutes during 18F-rhPSMA-7.3 PSMA PET-MRI imaging
Any neurologic disorder or psychiatric disorder that might confound postsurgical assessments
Has any condition(s), which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment
Received administration of an investigational drug within 30 days prior to study registration, and/or has planned administration of another investigational product or procedure during participation in this study

What this trial measures

  • Sensitivity of flotufolastat F-18 gallium (18F-rhPSMA-7.3) positron emission tomography (PET)/magnetic resonance (MRI) for the detection of lymph node metastasisUp to 12 months

    Defined as the presence of lymph node positivity determined on final pathologic analysis compared to findings on preoperative 18F-rhPSMA-7.3 PSMA PET/MRI. Continuous variables will be summarized as mean (standard deviation) or median (range) while categorical variables will be reported as frequency (percentage).