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Study on Radiometabolic Therapy with 177Lu-PSMA for Patients with Advanced or Metastatic Tumors

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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 treating advanced or metastatic tumors that are positive for a specific marker called PSMA, which can be detected using a type of imaging called PET/CT. The treatment being studied is called 177Lu-PSMA I&T, which is a solution given through an intravenous injection. This treatment is a form of radiometabolic therapy, which uses radioactive substances to target and treat cancer cells.

The purpose of the study is to evaluate how well the treatment controls the disease and to assess its safety. Participants in the study will receive the treatment and be monitored over a period of time to see how their tumors respond. The study will also look at any side effects that may occur during and after the treatment. The treatment period can last up to 24 weeks, and participants will have regular check-ups to monitor their health and the progress of their disease.

This study is designed to include patients with different types of tumors that have been confirmed to be PSMA-positive. The goal is to see if this treatment can be effective across various cancer types. The study will also track how long patients live after starting the treatment and how long it takes for the disease to progress. This information will help determine the potential benefits and risks of using 177Lu-PSMA I&T for treating advanced cancers.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of advanced or metastatic tumors that are positive for PSMA, as shown by PET/CT scans.

    Blood tests are performed to ensure normal organ and marrow function. This includes checking leukocyte, neutrophil, hemoglobin, and platelet levels, as well as liver and kidney function.

    A review of medical history and current health status is conducted to ensure no other effective treatments are available.

  2. Step 2

    Treatment administration

    The treatment involves the administration of 177Lu-PSMA I&T, a solution for infusion, given through an intravenous injection.

    The dosage and frequency of administration are determined based on individual health status and response to treatment. The treatment is repeated in cycles, with evaluations after each cycle.

  3. Step 3

    Monitoring and evaluation

    Regular monitoring is conducted to assess the response to treatment. This includes imaging tests such as PET/CT scans to evaluate tumor response.

    Blood tests are repeated to monitor organ function and detect any potential side effects.

    The primary goal is to achieve disease control, which includes complete or partial response, stable disease, or no progression.

  4. Step 4

    Follow-up

    After the treatment cycles are completed, follow-up assessments are conducted to monitor long-term outcomes and any late side effects.

    The follow-up period extends up to six months after the last treatment cycle to evaluate overall survival and progression-free survival.

Who can join the trial?

12 criteria

  • Patients must have confirmed advanced or metastatic solid tumors that are **PSMA-positive**. This means the tumors show a specific marker that can be detected by certain scans. If the tumor is in the brain and a biopsy (a small tissue sample) is not possible, a scan that strongly suggests the presence of the tumor is enough.
  • Patients must have normal organ and bone marrow function. This includes having enough white blood cells, red blood cells, and platelets, and normal levels of liver and kidney function tests.
  • Female participants must not be pregnant or breastfeeding.
  • Participants must be willing and able to give informed consent, meaning they understand the study and agree to participate.
  • Patients must have measurable disease, which means the tumor can be measured by scans. Patients with prostate cancer who have only bone lesions can also participate.
  • There must be evidence of the disease getting worse, shown by scans or specific blood tests.
  • For patients with prostate cancer, there must be proof of the disease getting worse in soft tissue or bone, or rising levels of a marker called PSA in the blood.
  • Patients will only be allowed to start treatment if a specific scan shows a certain level of PSMA positivity.
  • There should be no other effective treatment options available for the patient.
  • Participants must be male or female and at least 18 years old.
  • Participants must have a life expectancy of more than 12 weeks.
  • Participants must have an **ECOG performance status** of 2 or less. This is a scale that measures how well a patient can perform daily activities, with lower numbers indicating better function.

Who cannot join the trial?

3 criteria

  • Patients who do not have **PSMA PET/CT positive advanced/metastatic tumors**. This means the study is only for those whose tumors show up on a special type of scan called PSMA PET/CT.
  • Patients who are not within the specified age range. The study is open to certain age groups, so if you are outside of these groups, you cannot participate.
  • Patients who are part of a vulnerable population. This means people who might need extra protection or care, like those with certain disabilities or conditions, are not included.
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Investigated drugs

177Lu PSMA is a type of radiometabolic therapy used in this clinical trial. It is designed to target and treat advanced or metastatic tumors that are positive on PSMA PET/CT scans. This therapy involves using a radioactive substance, Lutetium-177, which is linked to a molecule that specifically binds to the Prostate-Specific Membrane Antigen (PSMA) found on the surface of certain cancer cells. Once the therapy binds to the cancer cells, the radiation helps to destroy them, potentially controlling the disease and improving patient outcomes.

What is already known about the treatment

177Lu PSMA – This medication is administered through radiometabolic therapy, specifically targeting PSMA PET/CT positive advanced or metastatic tumors. It is currently being studied in clinical trials to assess its effectiveness and safety in controlling disease progression. The main therapeutic indication is for treating advanced or metastatic tumors that are positive for PSMA, a protein often found in prostate cancer cells. At the molecular level, 177Lu PSMA works by binding to the PSMA protein on cancer cells, delivering targeted radiation to destroy these cells. It is classified as a radiopharmaceutical, which is a type of drug that contains radioactive substances used in the treatment of cancer.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It often progresses slowly and may not show symptoms in the early stages. As it advances, it can cause urinary problems, pelvic discomfort, and bone pain. The disease can spread to other parts of the body, such as bones and lymph nodes. It is typically detected through screening tests like PSA blood tests or imaging studies. The progression can vary greatly among individuals, with some experiencing rapid advancement while others have a more indolent course.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519346-75-00Protocol codeIRST100.58Estimated enrolment83 patientsSponsorIstituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).