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Localized Prostate CarcinomaNCT06389786

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

A study testing Bilateral Pelvic Lymph Node Dissection, Biospecimen Collection and Bone Scan in people with Localized Prostate Carcinoma and Oligometastatic Prostate Carcinoma, run by Mayo Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 to 85 years, men only
What is being tested?
Bilateral Pelvic Lymph Node Dissection, Biospecimen Collection and Bone Scan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
11 Jun 2024to 31 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 85 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Referral Office contact

855-776-0015

mayocliniccancerstudies@mayo.edu

United States1 site, 1 recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Ram A. Pathak, MD

    Recruiting

Other trials in United States

About this study

Official title: MC230504 Safe Omission of Pelvic Lymph Node Dissection (SOuND ) During Radical Prostatectomy: Diagnostic Accuracy of rhPSMA-7.3(18F) PET/CT, mpMRI and Patient Clinical Factors to Predict Lymph Node Metastasis

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To investigate the diagnostic ability of flotufolastat F-18 gallium (18F-rhPSMA-7.3) PSMA PET/MRI prior to radical prostatectomy in newly diagnosed, high-risk prostate cancer patients.

SECONDARY OBJECTIVES:

  1. Calculating the specificity, positive-predictive value, and negative-predictive value for the detection of lymph node positivity.

II. Investigating the rates of biochemical recurrence (BCR) as measured by post-operative prostate specific antigen (PSA) (PSA > 0.20) at pre-defined timepoints in patients.

OUTLINE:

Patients receive 18F-rhPSMA-7.3 intravenously (IV) and undergo PET/MRI up to 30 days prior to standard of care (SOC) robotic radical prostatectomy with bilateral pelvic lymph node dissection. Patients also undergo CT/MRI or bone scan/PET, as well as tissue collection during screening.

Upon completion of study treatment, patients are followed up at 6 weeks, 3 months, 9 months, and 12 months post-surgery.

Being tested
Bilateral Pelvic Lymph Node Dissection, Biospecimen Collection, Bone Scan, Computed Tomography, Electronic Health Record Review
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bilateral Pelvic Lymph Node DissectionProcedure or surgery

    Undergo bilateral pelvic lymph node dissection

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo tissue sample collection

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo bone scan

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Electronic Health Record ReviewOther

    Ancillary studies

  • Flotufolastat F-18 GalliumOther

    Also called (18F)-rhPSMA-7.3, 18F-rhPSMA-7.3, 18FrhPSMA-7.3, F-18-rhPSMA-7.3

    Given IV

  • Laparoscopic Radical Prostatectomy with RoboticsProcedure or surgery

    Also called RARP, Robot-assisted Radical Prostatectomy

    Undergo robotic radical prostatectomy

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI or PET/MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/MRI

Study groups in NCT06389786
Study groupRoleWhat they receive
Screening (18F-rhPSMA-7.3 PET/MRI)ExperimentalPatients 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.
Receives: Procedure: Bilateral Pelvic Lymph Node Dissection; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Other: Electronic Health Record Review; Other: Flotufolastat F-18 Gallium; Procedure: Laparoscopic Radical Prostatectomy with Robotics; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity of flotufolastat F-18 gallium (18F-rhPSMA-7.3) positron emission tomography (PET)/magnetic resonance (MRI) for the detection of lymph node metastasis

    Defined as the presence of lymph node positivity determined on final pathologic analysis compared to findings on preoperative 18F-rhPSMA-7.3 PSMA PET/MRI. Continuous variables will be summarized as mean (standard deviation) or median (range) while categorical variables will be reported as frequency (percentage).

    Measured: Up to 12 months

Secondary outcomes (7)

  1. Specificity

    Defined as absence of lymph node metastasis on final pathologic analysis compared to findings on preoperative 18F-rhPSMA-7.3 PSMA PET/MRI.

    Measured: Up to 12 months

  2. Positive predictive value//negative predictive value (PPV/NPV)

    Defined as findings on 18F-rhPSMA-7.3 prostate specific membrane antigen (PSMA) PET/MRI compared to the presence or absence of lymph node metastasis on final pathologic analysis. Proportion of correct results will be compared between rhPSMA-7.3(18F) PET/MRI and the standard care.

    Measured: Up to 120 months

  3. Prostate specific antigen (PSA): < 5, 5-10, 10-20, > 20

    Will investigate the impact of PSA as a clinicopathologic variable on lymph node metastasis when used alone and in combination with PSMA PET/MRI using 18F-rhPSMA-7.3.

    Measured: Up to 12 months

  4. Gleason score

    Will investigate the impact of Gleason score as a clinicopathologic variable on lymph node metastasis when used alone and in combination with PSMA PET/MRI using 18F-rhPSMA-7.3. Gleason score is a grading system for prostate cancer ranging from 6 (low-grade cancer) to 10 (high-grade cancer).

    Measured: Up to 12 months

  5. Digital rectal examination

    Will investigate the impact of digital rectal examination as clinicopathologic variable on lymph node metastasis when used alone and in combination with PSMA PET/MRI using 18F-rhPSMA-7.3.

    Measured: Up to 12 months

  6. Number of patients where management has changed

    Defined by the number of patients where PSMA PET/MRI depicts metastatic lesions (e.g. visceral/skeletal) or suspicious lymph nodes outside the true pelvis where standard of care imaging was negative. Proportion of correct results will be compared between rhPSMA-7.3(18F) PET/MRI and the standard care.

    Measured: Up to 12 months

  7. Rates of biochemical recurrent disease (BCR)

    BCR rates will be defined as PSA > 0.20 between patients with either negative or positive evidence of PSMA avid disease as indicated on the 18F-rhPSMA-7.3 PSMA PET /MRI and correlated to historical controls. Patients with positive and negative preop imaging results will be compared.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2024
  2. Study start11 Jun 2024
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06389786
Sponsor's protocol ID
MC230504
Other IDs
23-009377
Status last verified
Apr 2026
First submitted
25 Apr 2024
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Bilateral Pelvic Lymph Node Dissection, Biospecimen Collection and Bone Scan in people with Localized Prostate Carcinoma and Oligometastatic Prostate Carcinoma, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06389786.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.

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