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

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

Interventions

PROCEDURE

Bilateral Pelvic Lymph Node Dissection

Undergo bilateral pelvic lymph node dissection

PROCEDURE

Biospecimen Collection

Undergo tissue sample collection

PROCEDURE

Bone Scan

Undergo bone scan

PROCEDURE

Computed Tomography

Undergo CT

OTHER

Electronic Health Record Review

Ancillary studies

OTHER

Flotufolastat F-18 Gallium

Given IV

PROCEDURE

Laparoscopic Radical Prostatectomy with Robotics

Undergo robotic radical prostatectomy

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI or PET/MRI

PROCEDURE

Positron Emission Tomography

Undergo PET/MRI

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Ram A. Pathak, MD · Mayo Clinic

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

30 Years

Max Age

85 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-11

Primary Completion

2027-05-31

Completion

2027-05-31

Countries

• United States

Study Locations