Actively Recruiting
Safe Omission of Pelvic Lymph Node Dissection During Radical Prostatectomy Using rhPSMA-7.3 (18F) PET/MRI to Predict Lymph Node Metastasis in Localized High-Risk Prostate Cancer
Led by Mayo Clinic · Updated on 2026-04-06
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a special imaging scan called 18F-rhPSMA-7.3 PET/MRI to detect the risk of prostate cancer spreading to lymph nodes in men with localized high-risk prostate cancer who are scheduled for radical prostatectomy. This method aims to improve the accuracy of identifying patients who might benefit from pelvic lymph node dissection. The study focuses on newly diagnosed patients who have not received prior treatments and are planned for surgery. Participants receive an intravenous injection of the 18F-rhPSMA-7.3 tracer and undergo PET/MRI imaging up to 30 days before their standard robotic radical prostatectomy with bilateral pelvic lymph node dissection. Additional imaging such as CT, MRI, or bone scans and tissue sample collection are performed during screening. After surgery, patients are followed up at 6 weeks, 3 months, 9 months, and 12 months to monitor their condition. Throughout the study, researchers will assess diagnostic measures like sensitivity, specificity, and predictive values of the imaging to detect lymph node metastasis. They will also track prostate-specific antigen (PSA) levels and rates of biochemical recurrence up to 12 months after surgery. Various clinical evaluations, including digital rectal exams and Gleason scores, are conducted. The study duration for each participant includes the screening, imaging, surgery, and one-year follow-up to gather comprehensive data on the imaging's accuracy and patient outcomes.
CONDITIONS
Brief 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
- Diagnosed with high-risk localized prostate cancer selected for radical prostatectomy with extended lymph node dissection
- Hormone-nafve prostate cancer 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
- Ability and willingness to comply with study instructions and follow-up schedule
- Ability to provide written informed consent
You will not qualify if you...
- Planned neoadjuvant therapy for high-risk cancer
- History of more than two weeks of immunosuppressant treatment or cytotoxic chemotherapy within one month prior to 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 preoperative imaging
- Previous pelvic radiation treatment
- Obesity with body mass index over 40 kg/m2
- History of laparoscopic inguinal hernia repair with mesh
- Scheduled for chemotherapy, radiation, hormone therapy, or open surgery during the study period
- Inability to lie still for 75 minutes during PET/MRI imaging
- Neurologic or psychiatric disorders that could affect post-surgical assessments
- Conditions that seriously limit ability to participate or comply with treatment
- Receipt of investigational drugs within 30 days before registration or planned investigational treatments during study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 30 days
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person) involving 18F-rhPSMA-7.3 injection, PET/MRI, CT/MRI or bone scan, and tissue collection
Duration - Day of surgery plus immediate recovery period
Participants undergo standard of care robotic radical prostatectomy with bilateral pelvic lymph node dissection.
1 surgical visit (in-person)
Duration - Up to 12 months post-surgery
Participants are followed up to monitor recovery and biochemical recurrence through prostate specific antigen (PSA) assessments and other clinical evaluations.
4 follow-up visits at 6 weeks, 3 months, 9 months, and 12 months post-surgery (in-person)
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
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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