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Study of 177Lu-PSMA and Stereotactic Radiotherapy vs. Radiotherapy for Patients with Oligometastatic Prostate Cancer

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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 a type of prostate cancer known as oligometastatic prostate cancer. This condition occurs when prostate cancer has spread to a few other parts of the body. The study is comparing two treatment approaches: one group will receive a combination of a special drug called 177Lu-PSMA I&T and a precise form of radiation therapy known as stereotactic radiotherapy, while the other group will receive only stereotactic radiotherapy. The drug 177Lu-PSMA I&T is given through an intravenous infusion, which means it is administered directly into the bloodstream.

The purpose of the study is to see how well these treatments work in preventing the cancer from getting worse over a period of 12 months. Participants will be randomly assigned to one of the two treatment groups. Throughout the study, regular check-ups and tests will be conducted to monitor the participants' health and the progress of the cancer. The study aims to understand which treatment is more effective in controlling the cancer and improving the quality of life for patients.

Participants will be closely monitored for any side effects or changes in their condition. The study will also look at how long patients can go without needing additional hormone therapy, which is often used in prostate cancer treatment. The overall goal is to find the best approach to manage oligometastatic prostate cancer and improve outcomes for patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Upon joining the study, participants are randomly assigned to one of two groups. One group receives Lu-PSMA combined with stereotactic radiotherapy, while the other group receives radiotherapy alone.

  2. Step 2

    Treatment administration

    Participants in the Lu-PSMA group receive the medication through an intravenous infusion. The specific dosage and frequency are determined by the study protocol and medical team.

    Participants in both groups undergo stereotactic radiotherapy, a precise form of radiation therapy targeting cancer cells.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, participants attend regular follow-up appointments to monitor their health and the effectiveness of the treatment. This includes routine blood tests to measure prostate-specific antigen (PSA) levels and imaging tests to assess cancer progression.

    Participants complete quality of life assessments using the Functional Assessment of Cancer Therapy – Prostate (FACT-P) questionnaire.

  4. Step 4

    End of treatment evaluation

    At the end of the treatment period, participants undergo a final evaluation to determine the overall effectiveness of the treatment. This includes assessing PSA progression-free survival and any potential side effects experienced during the study.

  5. Step 5

    Long-term follow-up

    Participants continue to be monitored for a period after the treatment phase to assess long-term outcomes, including overall survival and any late-onset side effects.

Who can join the trial?

25 criteria

  • Patients must have prostate cancer with 1-3 **asymptomatic metastatic lesions**. These are cancer spots that have spread but do not cause symptoms. They should be **5.0 cm or smaller** or less than **250 cm³** in size, as shown by a CT/MRI or WBD-MRI scan.
  • Patients must be **18 years or older**.
  • Patients must understand the study's purpose and agree to participate by signing a written consent form.
  • Patients must have an **Eastern Cooperative Oncology Group performance status** of **2 or less**. This is a scale that measures how well a patient can perform daily activities.
  • Patients should have a **life expectancy** of at least **6 months**.
  • Patients must have **normal organ and marrow function**, which includes:
    • **Leukocytes** (a type of white blood cell) greater than **2,000/µL**.
    • **Absolute neutrophil count** (another type of white blood cell) greater than **1,000/µL**.
    • **Platelets** (cells that help with blood clotting) greater than **75,000/µL**.
    • **Total bilirubin** within normal limits, except for patients with **Gilbert’s syndrome**.
    • **AST (SGOT)/ALT (SGPT)** levels should be **2.5 times or less** than the upper normal limit.
    • **Creatinine** within normal limits.
    • If the patient is sexually active with a woman who can become pregnant, a **condom** and another **highly effective birth control method** must be used during treatment and for **6 months** after the last dose. The patient must also agree not to donate sperm for reproduction during this time.
    • Patients and their female partners must use **two acceptable birth control methods** starting at the screening visit and continuing until **6 months** after the last treatment. One method must be a **condom**, and the other can be:
      • Oral, injected, or implanted hormonal contraception by the female partner.
      • Placement of an **intrauterine device (IUD)** or **intrauterine system (IUS)** by the female partner.
      • Additional barrier method like an occlusive cap with spermicidal foam/gel/film/cream/suppository in the female partner.
      • **Tubal ligation** in the female partner.
      • **Vasectomy** or other procedure resulting in infertility for more than **6 months**.
      • A **PSMA-PET/CT positive scan** must match with lesions shown on the baseline CT/MRI or WBD-MRI.
      • Patients must have had their primary tumor treated with **surgery and/or radiation**. Previous **salvage radiation** to the prostate bed or pelvis is allowed.
      • Patients will only enter the treatment phase if the **diagnostic PET/CT PSMA SUV max** is **3 or higher**.
      • There must be **histologic confirmation** of cancer, meaning the cancer must be confirmed by examining tissue under a microscope.
      • **Prostate specific antigen (PSA)** levels must be **0.2 ng/mL or higher** but **50 ng/mL or lower**, and **Testosterone** levels must be **125 ng/dL or higher**.
      • The **PSA doubling time (PSADT)** must be **less than 15 months**. This is the time it takes for the PSA level to double, calculated from the time of relapse.
      • Patients who are unfit for or refuse **androgen deprivation therapy (ADT)** can participate.
      • Patients may have had previous **systemic therapy** and/or **ADT** related to their primary prostate cancer. They may also have had ADT with salvage radiation therapy.

Who cannot join the trial?

2 criteria

  • Patients who are not male cannot participate in the study.
  • Patients who are part of a vulnerable population, meaning those who might be at higher risk of harm or exploitation, are not eligible.
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Investigated drugs

  • Lu-PSMA

    is a type of targeted therapy used in the treatment of prostate cancer. It involves a radioactive substance that binds to a specific protein found on the surface of prostate cancer cells. This allows the radiation to be delivered directly to the cancer cells, helping to destroy them while minimizing damage to surrounding healthy tissue.

  • Stereotactic Radiotherapy

    is a form of radiation therapy that delivers high doses of radiation to a precise area. It is used to target and treat small, specific areas of cancer, such as oligometastatic prostate cancer, with minimal impact on surrounding healthy tissues. This therapy is known for its accuracy and effectiveness in controlling cancer growth.

What is already known about the treatment

Lu-PSMA – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating oligometastatic prostate cancer. It is not yet widely used in standard medical practice but shows promise in medical literature for its potential benefits. The main therapeutic indication is for prostate cancer that has spread to a limited number of sites. Lu-PSMA works by targeting the prostate-specific membrane antigen (PSMA) on cancer cells, delivering radiation directly to the tumor and minimizing damage to surrounding healthy tissue. It is classified as a radiopharmaceutical, which combines a radioactive component with a molecule that specifically targets cancer cells.

Investigated diseases

Oligometastatic Prostate Carcinoma – This is a form of prostate cancer where the disease has spread to a limited number of other parts of the body, typically fewer than five metastatic sites. It is considered an intermediate state between localized prostate cancer and widespread metastatic disease. The cancer cells in oligometastatic prostate carcinoma can grow and spread, but they do so at a slower rate compared to more advanced metastatic prostate cancer. The progression of this disease can vary, with some patients experiencing stable disease for extended periods, while others may see a gradual increase in the number of metastases. The condition is often sensitive to hormone therapy, which can help control the growth of cancer cells. Understanding the progression of oligometastatic prostate carcinoma is crucial for determining appropriate treatment strategies.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519347-15-00Protocol codeIRST185.09Estimated enrolment70 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).