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Study on Lutetium-177-PSMA and 18F-PSMA-1007 for Patients with Oligo-metastatic Hormone Sensitive Prostate Cancer

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 a type known as oligo-metastatic hormone-sensitive prostate cancer. The trial is investigating a treatment called Lutetium-177-PSMA, which is a form of radiation therapy that targets cancer cells. This treatment is compared to the current standard care, which involves delaying hormone therapy. The main goal is to see how effective the new treatment is in slowing down the progression of the disease over a period of six months.

Participants in the study will receive either the new treatment, Lutetium-177-PSMA, or follow the standard care. The treatment involves an injection of a solution that contains a radioactive substance, which is designed to target and destroy cancer cells. The study will monitor the participants to see how their cancer responds to the treatment and whether it helps in delaying the progression of the disease. The study will also look at other factors such as the participants' quality of life and any side effects they may experience.

The trial will last for several months, and participants will be closely monitored throughout the process. The researchers aim to gather valuable information that could lead to improved treatment options for patients with prostate cancer. This study is an important step in exploring new ways to manage and treat this type of cancer, potentially offering new hope for patients in the future.

The research process

The trial runs in 6 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, the patient will be informed about the trial's objectives and procedures. The patient must provide signed informed consent to participate.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history, laboratory tests, and imaging studies such as 18F-PSMA-PET-CT to identify metastases in bones or lymph nodes.

  3. Step 3

    Treatment administration

    The patient will receive treatment with lutetium (177Lu) vipivotide tetraxetan, administered as an intravenous infusion. The dosage and frequency will be determined by the study protocol and the patient's specific condition.

  4. Step 4

    Monitoring and follow-up

    The patient will be monitored regularly to assess the response to treatment. This includes follow-up visits for imaging studies, laboratory tests, and evaluation of any side effects. The primary aim is to observe disease progression and compare it with the standard care group.

  5. Step 5

    End of treatment evaluation

    At the end of the treatment period, the patient will undergo a comprehensive evaluation to determine the effectiveness of the therapy. This includes assessing the progression of the disease and any changes in the patient's condition.

  6. Step 6

    Long-term follow-up

    The patient will continue to be monitored for a period of up to 6 months to evaluate long-term outcomes, including progression-free survival and quality of life assessments.

Who can join the trial?

16 criteria

  • Must have a confirmed diagnosis of prostate cancer with enough stored tumor material until the study ends.
  • Must have certain blood test results:
    • White blood cells greater than 3.0 x 109/l
    • Platelet count greater than 75 x 109/l
    • Hemoglobin greater than 6.2 mmol/l
    • ASAT and ALAT (liver enzymes) less than 3 times the upper normal limit
    • MDRD-GFR (a kidney function test) equal to or greater than 50 ml/min
    • Must sign a form agreeing to participate in the study.
    • Must have a biochemical recurrence, meaning PSA (a prostate-specific antigen) level greater than 1.0 μg/l.
    • PSA-doubling time must be less than 6 months, with PSA levels rising in at least two tests taken one week apart, starting from a minimum value of 0.2 μg/l.
    • Must have positive results for metastases (cancer spread) in bones and/or lymph nodes, with at least 1 but no more than 5 metastases, as shown by a specific scan called 18F-PSMA-PET-CT.
    • Local treatment for cancer spread with radiotherapy or surgery is no longer an option, either due to previous treatments, the location of the cancer, or if the patient refuses these treatments.
    • Must not have had previous hormonal therapy or chemotherapy with taxane-based drugs, except for local prostate cancer treated with radiotherapy and short-term hormone therapy, which must have been stopped at least 6 months ago.
    • Must have a detectable lesion on the 18F-PSMA PET/CT scan with significant PSMA avidity, defined by a SUVmax greater than 15.
    • Must have an ECOG performance status of 0-1, which means being fully active or having some symptoms but being able to carry out light work.
    • Must have a life expectancy of more than 6 months.
    • Must be male.

Who cannot join the trial?

2 criteria

  • Only male patients can participate in the study. Female patients are excluded.
  • Patients who are considered part of a vulnerable population are not eligible. This means people who might have difficulty giving informed consent or are at higher risk of harm.
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Investigated drugs

  • 177Lu-PSMA RLT

    is a type of targeted radiation therapy used in this trial. It involves using a radioactive substance, Lutetium-177, which is linked to a molecule that specifically targets prostate-specific membrane antigen (PSMA) found on prostate cancer cells. This therapy aims to deliver radiation directly to the cancer cells, helping to reduce or control the spread of prostate cancer in patients with oligo-metastatic, hormone-sensitive prostate cancer.

  • Deferred Androgen Deprivation Therapy

    is the current standard of care for patients in this trial. This therapy involves delaying the use of treatments that lower male hormones, such as testosterone, which can fuel the growth of prostate cancer. The goal is to manage the disease while minimizing the side effects associated with hormone therapy.

What is already known about the treatment

Lutetium-177-PSMA – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating prostate cancer, specifically in patients with oligo-metastatic, hormone-sensitive forms of the disease. It is not yet widely adopted in standard medical practice, as research is ongoing to determine its efficacy and safety. The main therapeutic indication is prostate cancer, where it targets prostate-specific membrane antigen (PSMA) on cancer cells, delivering targeted radiation to destroy them. It belongs to the class of radiopharmaceuticals, which are drugs that contain radioactive substances used to treat 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 lead to difficulties in urination, blood in urine, or pelvic discomfort. The cancer can spread to nearby tissues or other parts of the body, such as bones and lymph nodes. Hormone-sensitive prostate cancer responds to treatments that lower testosterone levels, which can slow the growth of the cancer. Oligo-metastatic prostate cancer refers to a state where the cancer has spread to a limited number of sites outside the prostate.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509881-39-00Estimated enrolment58 patientsSponsorStichting Radboud universitair medisch centrum

sourced from the EU Clinical Trials Register and site verification

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