Recruiting

18F-rhPSMA-7.3

Sponsor:

Mayo Clinic

Code:

NCT06389786

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

Eligibility Criteria

Sex: Male

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Bilateral Pelvic Lymph Node Dissection

Biospecimen Collection

Bone Scan

Computed Tomography

Electronic Health Record Review

Study Details

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.

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

Study ID

NCT06389786

Start date

Jun 11, 2024

Status verified date

Apr, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 30 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

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.

Interventions

Bilateral Pelvic Lymph Node Dissection

Undergo bilateral pelvic lymph node dissection

Biospecimen Collection

Undergo tissue sample collection

Bone Scan

Undergo bone scan

Computed Tomography

Undergo CT

Electronic Health Record Review

Ancillary studies

Flotufolastat F-18 Gallium

Given IV

Laparoscopic Radical Prostatectomy with Robotics

Undergo robotic radical prostatectomy

Magnetic Resonance Imaging

Undergo MRI or PET/MRI

Positron Emission Tomography

Undergo PET/MRI

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 and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Ram A. Pathak, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 6, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-06.