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

Description

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

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Study Details

Study overview

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.

Safe Omission of Pelvic Lymph Node Dissection (SOuND) During Radical Prostatectomy: Diagnostic Accuracy of RhPSMA-7.3(18F) PET/CT, MpMRI and Patient Clinical Factors to Predict Lymph Node Metastasis

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

Condition
Localized Prostate Carcinoma
Intervention / Treatment

-

Contacts and Locations

Jacksonville

Mayo Clinic in Florida, Jacksonville, Florida, United States, 32224-9980

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male subjects with at least age 30 to 85
  • * 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 18F-rhPSMA-7.3 PSMA
  • * Patient has the willingness to comply with instruction of the investigator
  • * Patient has the willingness to comply with follow-up surveillance
  • * Have ability to provide full written consent
  • * 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
  • * Clinical oligometastatic disease with \> 3 nodes positive on 18F-rhPSMA-7.3 PSMA
  • * Previous history of pelvic radiation
  • * Patients with obesity defined as body mass index (BMI) \> 40 kg/m\^2
  • * History of prior mesh for inguinal hernia repair
  • * 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, and/or has planned administration of another investigational product or procedure during participation in this study

Ages Eligible for Study

30 Years to 85 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Ram A. Pathak, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2026-05