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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT06389786
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
MALE
Age
30 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Bilateral Pelvic Lymph Node Dissection — PROCEDURE
    Undergo bilateral pelvic lymph node dissection
  • Biospecimen Collection — PROCEDURE
    Undergo tissue sample collection
  • Bone Scan — PROCEDURE
    Undergo bone scan
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Flotufolastat F-18 Gallium — OTHER
    Given IV
  • Laparoscopic Radical Prostatectomy with Robotics — PROCEDURE
    Undergo robotic radical prostatectomy
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI or PET/MRI
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/MRI

Study Details

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.

Key Dates

Start date
Jun 11, 2024
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: 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.

Primary Outcome Measure

Sensitivity of flotufolastat F-18 gallium (18F-rhPSMA-7.3) positron emission tomography (PET)/magnetic resonance (MRI) for the detection of lymph node metastasis [ Time Frame: Up to 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
[email protected]
855-776-0015
Ram A. Pathak, MD (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic in Florida· Jacksonville, FL

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