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

NCT06389786 | Recruiting

• 3 other identifiers: MC230504NCI-2024-0330623-009377
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial evaluates the use of an imaging scan (18F-rhPSMA-7.3 positron emission tomography \[PET\]/magnetic resonance imaging \[MRI\]) for identifying patients who are at risk of having their disease spread to the lymph nodes in those undergoing radical prostatectomy for prostate cancer that has not spread to other parts of the body (localized). Prostate specific membrane antigen (PSMA) PET/computed tomography (CT) has emerged as an option to stage newly diagnosed high risk prostate cancer patients. PSMA PET/CT has demonstrated improved diagnostic accuracy for identifying metastasis. PET is procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is used. Because cancer cells often use more glucose than normal cells, the pictures can be used to find cancer cells in the body. MRI is procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. This study may help researchers learn whether 18F-rhPSMA-7.3 PET/ MRI may improve predicting which patients are at risk of lymph node metastases and who are suitable candidates for pelvic lymph node dissection in patients with localized high-risk prostate cancer undergoing radical prostatectomy.

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

Outcome Measures

Primary Outcomes (1)

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

  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).

  Up to 12 months

Secondary Outcomes (7)

• Specificity

  Up to 12 months

• Positive predictive value//negative predictive value (PPV/NPV)

  Up to 120 months

• Prostate specific antigen (PSA): < 5, 5-10, 10-20, > 20

  Up to 12 months

• Gleason score

  Up to 12 months

• Digital rectal examination

  Up to 12 months

Study Arms (1)

Screening (18F-rhPSMA-7.3 PET/MRI)

EXPERIMENTAL

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.

Procedure: Bilateral Pelvic Lymph Node Dissection; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Other: Electronic Health Record Review; Other: Flotufolastat F-18 Gallium; Procedure: Laparoscopic Radical Prostatectomy with Robotics; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

Interventions

Bilateral Pelvic Lymph Node Dissection PROCEDURE

Undergo bilateral pelvic lymph node dissection

Screening (18F-rhPSMA-7.3 PET/MRI)

Biospecimen Collection PROCEDURE

Undergo tissue sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Screening (18F-rhPSMA-7.3 PET/MRI)

Bone Scan PROCEDURE

Undergo bone scan

Also known as: Bone Scintigraphy

Screening (18F-rhPSMA-7.3 PET/MRI)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Screening (18F-rhPSMA-7.3 PET/MRI)

Electronic Health Record Review OTHER

Ancillary studies

Screening (18F-rhPSMA-7.3 PET/MRI)

Flotufolastat F-18 Gallium OTHER

Given IV

Also known as: (18F)-rhPSMA-7.3, 18F-rhPSMA-7.3, 18FrhPSMA-7.3, F-18-rhPSMA-7.3, Fluorine F 18 Radiohybrid PSMA-7.3, Fluorine F 18 rhPSMA-7.3, Fluorine-18 rhPSMA-7.3, Posluma, rhPSMA-7.3 (18F)

Screening (18F-rhPSMA-7.3 PET/MRI)

Laparoscopic Radical Prostatectomy with Robotics PROCEDURE

Undergo robotic radical prostatectomy

Also known as: RARP, Robot-assisted Radical Prostatectomy

Screening (18F-rhPSMA-7.3 PET/MRI)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI or PET/MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Screening (18F-rhPSMA-7.3 PET/MRI)

Positron Emission Tomography PROCEDURE

Undergo PET/MRI

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Screening (18F-rhPSMA-7.3 PET/MRI)

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Specimen Handling; Robotics; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Automation; Technology; Technology, Industry, and Agriculture; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Ram A. Pathak, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 29, 2024
• Study Start: June 11, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 24, 2025

Record last verified: 2025-10

Locations

US (1)