Actively Recruiting
Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer
Led by Mayo Clinic · Updated on 2026-04-06
50
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male subjects aged 30 to 85 years
- Primary diagnosis of prostate cancer selected for surgical intervention (radical prostatectomy with extended lymph node dissection)
- Primary diagnosis of untreated high-risk localized prostate cancer by AUA guidelines confirmed by contrast-enhanced prostate MRI and tissue sampling
- Planned elective radical prostatectomy with extended pelvic lymph node dissection
- Clinical oligometastatic disease with 3 or fewer positive lymph nodes on standard imaging within 6 months before surgery
- Willingness to comply with investigator instructions and follow-up surveillance
- Ability to provide written informed consent
You will not qualify if you...
- High-risk cancer planned for neoadjuvant therapy
- History of more than two weeks treatment with immunosuppressants or cytotoxic chemotherapy within 1 month prior to screening or anticipated need during screening
- Prior hormonal therapy such as Lupron or oral antiandrogens within 12 weeks before registration
- Clinical oligometastatic disease with more than 3 positive lymph nodes on imaging before surgery
- Previous pelvic radiation treatment
- Body mass index (BMI) over 40 kg/m2
- History of prior laparoscopic inguinal hernia repair with mesh
- Scheduled to receive chemotherapy, radiation, hormone therapy, or open surgery during the study period
- Inability to lie still for 75 minutes during PET/MRI imaging
- Any neurological or psychiatric disorder affecting post-surgical assessments
- Any condition seriously compromising ability to participate, sign consent, or known poor adherence to medical treatment
- Received investigational drug within 30 days before study registration or planned investigational product use during the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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