NCT06389786 Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer
| NCT ID | NCT06389786 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Localized Prostate Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-06-11 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-06-11 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Male subjects ≥ 30 and ≤ 85 years old * 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 preoperative standard of care imaging of prostate region within 6 months of surgery * Patient agrees to comply with the investigator instructions * Patient agrees to comply with the follow-up surveillance schedule * Have ability to provide full written consent Exclusion Criteria: * 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 ≤ 12 weeks prior to registration * Clinical oligometastatic disease with \> 3 nodes positive preoperative standard of care imaging of prostate region * Previous history of pelvic radiation * Patients with obesity defined as body mass index (BMI) \> 40 kg/m\^2 * History of prior laparoscopic inguinal hernia repair with mesh * 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 registration, and/or has planned administration of another investigational product or procedure during participation in this study
Contact & Investigator
Ram A. Pathak, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06389786 clinical trial?
This trial is open to male participants only, aged 30 Years or older, up to 85 Years, studying Localized Prostate Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06389786 currently recruiting?
Yes, NCT06389786 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT06389786 trial being conducted?
This trial is being conducted at Jacksonville, United States.
Who is sponsoring the NCT06389786 clinical trial?
NCT06389786 is sponsored by Mayo Clinic. The principal investigator is Ram A. Pathak, MD at Mayo Clinic. The trial plans to enroll 50 participants.