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Study of Lutetium (177Lu) Vipivotide Tetraxetan for Patients with High-Risk Localized or Locally Advanced Prostate Cancer Eligible for Surgery

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying prostate cancer, specifically in patients who have high-risk, localized, or locally advanced forms of the disease. The treatment being investigated is called [177Lu]Lu-PSMA-617, which is a type of radiopharmaceutical. This means it is a radioactive substance used to target and treat cancer cells. The treatment is administered directly into the arteries, which is known as intra-arterial administration. The purpose of the study is to evaluate the safety and feasibility of using this treatment before surgery in patients who are scheduled for a procedure called radical prostatectomy, which involves the removal of the prostate gland.

Participants in the study will receive the treatment [177Lu]Lu-PSMA-617 before their planned surgery. The study will monitor how well patients tolerate the treatment and whether it is safe to use in this way. Researchers will also look at how the treatment affects the timing of the surgery and any potential side effects that may occur. The study aims to gather information on how the treatment impacts the cancer and whether it can help reduce the size of the tumor before surgery.

Throughout the study, the effects of the treatment on the cancer will be assessed using various medical tests, including imaging scans. The study will also track any changes in prostate-specific antigen (PSA) levels, which is a marker used to evaluate prostate cancer. The ultimate goal is to determine if this approach can improve outcomes for patients with high-risk prostate cancer who are undergoing surgery.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as a diagnosis of high-risk localized or locally advanced prostate cancer.

    The patient must have a confirmed adenocarcinoma of the prostate and meet other health and diagnostic criteria.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the patient's overall health status, including bone marrow, liver, and kidney function.

    A PSMA-PET scan is performed to confirm PSMA-positive disease.

  3. Step 3

    Treatment preparation

    The patient is prepared for the intra-arterial administration of the medication Pluvicto, which contains the active substance lutetium (177lu) vipivotide tetraxetan.

    This preparation includes ensuring the patient is a candidate for intra-arterial treatment and scheduled for radical prostatectomy with pelvic lymph node dissection.

  4. Step 4

    Medication administration

    The medication is administered intra-arterially as a solution for injection or infusion.

    The dosage and frequency are determined by the study protocol, focusing on safety and tolerability.

  5. Step 5

    Monitoring and follow-up

    The patient is monitored for any adverse events related to the therapy.

    Regular follow-up appointments are scheduled to assess the patient's response to the treatment, including PSA levels and pathological response.

  6. Step 6

    Surgery

    The patient undergoes radical prostatectomy with pelvic lymph node dissection as planned.

    The timing of the surgery may be adjusted based on the patient's response to the treatment and any adverse events experienced.

  7. Step 7

    Post-surgery evaluation

    After surgery, the patient's recovery and any residual disease are evaluated.

    The study measures outcomes such as pathological complete response and minimal residual disease.

Who can join the trial?

14 criteria

  • The patient must have a confirmed diagnosis of prostate cancer, specifically a type called adenocarcinoma.
  • The cancer must be considered high-risk, which can be determined by:
    • A Gleason sum score of 4+4 or higher. The Gleason score is a way to grade prostate cancer based on its appearance under a microscope.
    • Any Gleason score with a PSA level of 20 ng/mL or higher. PSA is a protein produced by the prostate, and high levels can indicate cancer.
    • The cancer can also be locally advanced, which means it has spread beyond the prostate but not to distant parts of the body. This can be shown by:
      • Extracapsular extension, meaning the cancer has spread outside the prostate capsule, confirmed by special imaging tests like mpMRI or PSMA-PET scan.
      • Positive pelvic lymph nodes, which are small glands that can show cancer spread, seen on a PSMA-PET scan.
      • Suspicion of pelvic lymph node involvement on regular imaging tests.
      • The patient must not have received any treatment for prostate cancer before.
      • The patient must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but do not need to stay in bed.
      • The patient must be a suitable candidate for a specific type of treatment called intra-arterial treatment, as determined by the study doctor.
      • The patient must be scheduled for a surgery called radical prostatectomy, which involves removing the prostate and some surrounding tissue, including pelvic lymph nodes.
      • The patient must have adequate function of the bone marrow, liver, and kidneys.
      • The patient must agree to use a condom during all sexual activities.
      • The patient must have evidence of PSMA-positive disease, which means the cancer cells show a specific marker seen on a PSMA-PET scan.
      • The study is open to male patients only.

Who cannot join the trial?

4 criteria

  • Patients who are not male cannot participate.
  • Patients who do not have high-risk localized or locally advanced prostate cancer cannot participate.
  • Patients who are not scheduled for a radical prostatectomy, which is a surgery to remove the prostate gland, cannot participate.
  • Patients who are considered part of a vulnerable population, meaning they might need special protection or care, cannot participate.
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Investigated drugs

[177Lu]Lu-PSMA-617 is a medication being studied for its potential use in treating prostate cancer. It is administered directly into the arteries to target high-risk, localized, or locally advanced prostate cancer. The goal is to evaluate its safety and how well patients can tolerate it before they undergo surgery to remove the prostate. This treatment is being tested to see if it can effectively reduce the cancer before surgery.

What is already known about the treatment

[177Lu]Lu-PSMA-617 – This medication is administered intra-arterially and is currently being studied in clinical trials for its safety and feasibility in treating high-risk localized or locally advanced prostate cancer. It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication is for patients who are candidates for radical prostatectomy. At the molecular level, it targets the prostate-specific membrane antigen (PSMA) on prostate cancer cells, delivering a radioactive payload to destroy cancer cells. It is classified pharmacologically as a radiopharmaceutical agent.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It is often categorized by its risk level and stage, such as localized, locally advanced, or high-risk. Localized prostate cancer is confined to the prostate, while locally advanced cancer has spread to nearby tissues. High-risk prostate cancer is more likely to grow and spread quickly. The progression of prostate cancer can vary, with some cases remaining slow-growing and others advancing rapidly. Symptoms may include difficulty urinating, blood in urine, or pelvic discomfort, but early stages often present no symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-500838-28-00Protocol codeLUPUSEstimated enrolment22 patientsSponsorUniversitaetsklinikum Essen AöR

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