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Evaluation of [99mTc]PSMA I&S PET‑Guided Navigation with Electromagnetic Tracking in miN1 Prostate Cancer Patients Undergoing Radio‑Guided Surgery

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on Prostate Cancer and uses an injectable imaging agent called [99mTc]PSMA I&S. The goal is to see if combining a special scan known as PET with electromagnetic tracking and a surgical technique called PSMA-RGS can help surgeons find and remove cancer‑affected lymph nodes more accurately during robot‑assisted prostate removal (RARP) that includes either an extended pelvic lymph node dissection (ePLND) or a sentinel lymph node dissection (SLND).

Participants receive a small intravenous dose of the tracer before surgery. The tracer makes cancer cells glow on the PET scan, and the electromagnetic system guides the surgeon’s instruments to the glowing spots while the operation is performed. After the procedure, a blood test measuring PSA levels is done about six weeks later to check if the cancer marker is below 0.1 ng/mL, indicating a biochemical complete response.

The study monitors any side effects from the tracer injection and records how well the combined imaging and navigation methods identify cancer in the lymph nodes compared with standard imaging alone. Results will help determine whether this approach improves the accuracy of detecting nodal metastases and reduces the chance of cancer returning.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Assessment After Enrollment

    After joining the study, you will undergo a baseline clinical assessment that includes a physical examination, blood tests, and measurement of prostate‑specific antigen (PSA) to establish your starting condition.

    The medical team will also review your medical history and confirm that you meet the study criteria for prostate cancer treatment.

  2. Step 2

    Administration of Radiopharmaceutical

    You will receive a single intravenous injection of [99mTc]PSMA I&S at a dose of 700 megabecquerel (MBq).

    The injection is given once, usually a few hours before the imaging procedure, and no further doses are required.

  3. Step 3

    PET Imaging with Electromagnetic Tracking

    After the injection, you will undergo a PET (positron emission tomography) scan that uses the radiopharmaceutical to highlight prostate‑specific membrane antigen (PSMA)–positive lymph nodes.

    During the scan, an electromagnetic tracking system records the exact location of any detected nodes to guide the upcoming surgery.

  4. Step 4

    Surgical Planning

    The imaging results are reviewed by the surgical team to plan the precise removal of cancer‑affected tissue.

    The plan includes whether you will have a robot‑assisted radical prostatectomy (RARP) combined with extended pelvic lymph node dissection (ePLND) or a sentinel lymph node dissection (SLND), using the PSMA‑guided navigation.

  5. Step 5

    Prostatectomy and PSMA‑Guided Surgery

    You will undergo RARP (robot‑assisted radical prostatectomy) together with either ePLND or SLND.

    During the operation, the surgeon uses PSMA‑RGS (PSMA‑radio‑guided surgery) combined with the electromagnetic tracking information to locate and remove cancer‑positive lymph nodes accurately.

  6. Step 6

    Immediate Post‑Operative Monitoring

    After surgery, you will be monitored in the recovery area for any immediate side effects related to the radiopharmaceutical or the surgical devices.

    The medical team will record any adverse events according to the study safety guidelines.

  7. Step 7

    Six‑Week Follow‑Up PSA Test

    Six weeks after the operation, you will return for a blood test to measure PSA levels.

    A result of less than 0.1 nanogram per milliliter (ng/mL) indicates a biochemical complete response (bCR) according to the study’s primary endpoint.

  8. Step 8

    Final Study Evaluation

    The study team will evaluate the imaging accuracy, surgical outcomes, and any adverse events that occurred during the trial.

    Your individual results will be compared with the study’s objectives to determine the effectiveness of the PSMA‑PET‑guided navigation approach.

Who can join the trial?

4 criteria

  • Must be a man who is 18 years old or older when signing the consent form.
  • Must be able to sign a written consent form.
  • Must have a new diagnosis of prostate cancer that is classified as miN1M0 (a small amount of cancer has spread to nearby lymph nodes but not to distant parts of the body) or have a limited return of cancer (oligorecurrent) with the same miN1M0 status.
  • Must be able to undergo RARP (robot‑assisted laparoscopic removal of the prostate) and the related lymph‑node surgery, either ePLND (extended removal of pelvic lymph nodes) or SPLND (selective removal of pelvic lymph nodes).

Who cannot join the trial?

5 criteria

  • You have received hormone therapy (treatment that lowers male hormones) before or at the same time as the study, either before surgery (neoadjuvant) or after surgery (adjuvant).
  • You are unable to finish all the required scans and images that are part of the study (the imaging protocol).
  • Your cancer has already spread to distant sites that appear as miM1 on a special scan called PSMA-PET (a type of PET scan that looks for prostate‑specific membrane antigen).
  • You have medical reasons that make the planned operation unsafe, including the use of a robot‑assisted surgical system (robot‑assisted surgery).
  • You have a heart device called a cardiac pacemaker that could interfere with the navigation equipment used in the study.
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Investigated drugs

[99mTc]PSMA I&S is a radioactive tracer that attaches to a protein called PSMA, which is found on many prostate cancer cells. In the trial it is given by an intravenous injection before surgery. The tracer lights up the cancer‑containing lymph nodes on a PET scan, and an electromagnetic tracking system helps the surgeon see exactly where those nodes are during the operation. By using this tracer, doctors aim to find and remove tiny cancer spread more accurately, which may improve the chance of a very low PSA level after surgery.

What is already known about the treatment

[99mTc]PSMA I&S - This medicine is given as an intravenous injection of a small amount of radioactive material. It is currently an investigational radiopharmaceutical used mainly in research and early clinical studies for prostate cancer imaging. The agent works by attaching to a protein called PSMA that is found on many prostate‑cancer cells, and the attached technetium‑99m emits signals that can be seen on special scans. It is classified as a PSMA‑targeted diagnostic radiopharmaceutical.

Investigated diseases

Prostate Cancer - Prostate cancer is a growth of abnormal cells in the prostate gland that can form a tumor. It usually starts in the outer portion of the gland and may expand into surrounding tissue. As the tumor enlarges, it can invade nearby structures such as the seminal vesicles. Cancer cells may travel through the lymphatic system to involve regional lymph nodes. In advanced stages the disease can spread to distant sites like bone.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-526915-12-00Protocol codeGR202412380349GPSMAEstimated enrolment54 patientsSponsorOspedale San Raffaele S.r.l.

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