Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer
NCT ID: NCT06389786
Last Updated: 2025-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
50 participants
INTERVENTIONAL
2024-06-11
2026-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance
NCT05852041
PSMA PET Scan and mpMRI for Prostate Cancer Detection
NCT05820724
Prostate Specific Membrane Antigen (PMSA)-Based PET Imaging of High Risk Prostate Cancer
NCT03976843
An Investigational Scan (18F-rhPSMA-7.3 PET-mpMRI) for Targeted Prostate Biopsy Using TRUS-MR Fusion Technique
NCT06865768
18F-PSMA PET and MRI in the Primary Staging of Prostate Cancer Patients
NCT05141760
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To investigate the diagnostic ability of flotufolastat F-18 gallium (18F-rhPSMA-7.3) PSMA PET/MRI prior to radical prostatectomy in newly diagnosed, high-risk prostate cancer patients.
SECONDARY OBJECTIVES:
I. Calculating the specificity, positive-predictive value, and negative-predictive value for the detection of lymph node positivity.
II. Investigating the rates of biochemical recurrence (BCR) as measured by post-operative prostate specific antigen (PSA) (PSA \> 0.20) at pre-defined timepoints in patients.
OUTLINE:
Patients receive 18F-rhPSMA-7.3 intravenously (IV) and undergo PET/MRI up to 30 days prior to standard of care (SOC) robotic radical prostatectomy with bilateral pelvic lymph node dissection. Patients also undergo CT/MRI or bone scan/PET, as well as tissue collection during screening.
Upon completion of study treatment, patients are followed up at 6 weeks, 3 months, 9 months, and 12 months post-surgery.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Screening (18F-rhPSMA-7.3 PET/MRI)
Patients receive 18F-rhPSMA-7.3 IV and undergo PET/MRI up to 30 days prior to SOC robotic radical prostatectomy with bilateral pelvic lymph node dissection. Patients also undergo CT/MRI or bone scan/PT, as well as tissue collection during screening.
Bilateral Pelvic Lymph Node Dissection
Undergo bilateral pelvic lymph node dissection
Biospecimen Collection
Undergo tissue sample collection
Bone Scan
Undergo bone scan
Computed Tomography
Undergo CT
Electronic Health Record Review
Ancillary studies
Flotufolastat F-18 Gallium
Given IV
Laparoscopic Radical Prostatectomy with Robotics
Undergo robotic radical prostatectomy
Magnetic Resonance Imaging
Undergo MRI or PET/MRI
Positron Emission Tomography
Undergo PET/MRI
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bilateral Pelvic Lymph Node Dissection
Undergo bilateral pelvic lymph node dissection
Biospecimen Collection
Undergo tissue sample collection
Bone Scan
Undergo bone scan
Computed Tomography
Undergo CT
Electronic Health Record Review
Ancillary studies
Flotufolastat F-18 Gallium
Given IV
Laparoscopic Radical Prostatectomy with Robotics
Undergo robotic radical prostatectomy
Magnetic Resonance Imaging
Undergo MRI or PET/MRI
Positron Emission Tomography
Undergo PET/MRI
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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
30 Years
85 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mayo Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ram A. Pathak, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic in Florida
Jacksonville, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Related Links
Access external resources that provide additional context or updates about the study.
Mayo Clinic Clinical Trials
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2024-03306
Identifier Type: REGISTRY
Identifier Source: secondary_id
23-009377
Identifier Type: OTHER
Identifier Source: secondary_id
MC230504
Identifier Type: OTHER
Identifier Source: secondary_id
MC230504
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.