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Phase 2 study of lutetium (177Lu) vipivotide tetraxetan with ADT and darolutamide in patients with 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

The study focuses on metastatic hormone-sensitive prostate cancer, a type of prostate cancer that has spread to other parts of the body but still responds to hormone‑lowering treatments. Participants have a confirmed diagnosis based on a tissue sample and imaging that shows at least one bone or soft‑tissue lesion. The investigational medication is Pluvicto®, which contains the radioactive substance lutetium (177Lu) vipivotide tetraxetan. All participants also receive the usual hormone therapy known as ADT (androgen deprivation therapy) and the drug Nubeqa®, which is a medicine that blocks signals that help prostate cancer grow.

The purpose of the study is to compare the effectiveness of adding Pluvicto® to the standard treatment regimen versus using the standard regimen alone, measured by the change in PSA levels over the first year. After an initial screening, participants receive an intravenous infusion of the study drug at scheduled intervals while continuing their regular hormone therapy and Nubeqa®. Throughout the approximately 12‑month period, they attend regular clinic visits for blood tests, imaging scans, and questionnaires about quality of life, allowing researchers to monitor safety, disease status, and any side effects. The study continues with follow‑up visits after the treatment phase to collect additional information.

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 joining the study, you will undergo a baseline assessment that includes a review of your medical history, a physical examination, blood tests that measure prostate‑specific antigen (**PSA**) and other safety parameters, and imaging studies to confirm the presence of bone or soft‑tissue lesions.

    The purpose of these assessments is to establish a starting point for evaluating the effects of the study treatments.

  2. Step 2

    Randomization

    Based on the baseline information, you will be randomly assigned to receive either **Pluvicto** together with standard of care or standard of care alone.

    Randomization ensures that the comparison between the two groups is unbiased.

  3. Step 3

    Start of Standard of Care Treatment

    You will begin **androgen deprivation therapy (ADT)**, which reduces testosterone levels and is given continuously for the duration of the study.

    You will also start taking **Nubeqa** (darolutamide) as an oral tablet once daily, following the dosing instructions provided by your physician.

  4. Step 4

    First Pluvicto Infusion

    If you are assigned to the **Pluvicto** arm, you will receive a single intravenous infusion of **8140 MBq** (megabecquerels) of the radiopharmaceutical solution.

    The infusion is administered through a vein over a short period, typically under close medical supervision.

  5. Step 5

    Post‑Infusion Monitoring

    After the infusion, you will be observed for several hours to monitor for any immediate side effects.

    Blood tests will be repeated to check kidney function, blood counts, and **PSA** levels.

  6. Step 6

    Scheduled Follow‑Up Visits

    You will attend regular follow‑up visits beginning two weeks after the infusion, then at four weeks, and subsequently **monthly** until month 12.

    During each visit, your **PSA** will be measured, safety blood tests will be performed, and you will be asked about any symptoms or adverse events.

    Imaging studies will be repeated at predefined intervals (for example, every 12 weeks) to assess disease status.

  7. Step 7

    Continuation of Standard of Care

    Throughout the 12‑month study period, you will continue **ADT** and daily **Nubeqa** as prescribed.

    These medications are taken continuously to maintain control of hormone‑sensitive prostate cancer.

  8. Step 8

    End‑of‑Study Assessments

    At month 12, a final assessment will be performed, including a **PSA** measurement, imaging to evaluate disease progression, and questionnaires that measure **quality‑of‑life**.

    All adverse events that occurred from the first infusion until the end of documentation will be recorded.

Who can join the trial?

15 criteria

  • Provide a signed informed consent form that shows you understand the study and agree to take part.
  • Be a male aged 18 years or older (there is no upper age limit).
  • Have a diagnosis of synchronous metastatic hormone‑sensitive prostate cancer with a confirmed adenocarcinoma (a type of gland‑forming cancer) based on a prostate tissue sample taken now or in the past.
  • Be able to understand what the study involves and follow the study procedures.
  • If you are living with HIV, you must be otherwise healthy and have a low risk of developing serious AIDS‑related problems.
  • Have received Androgen Deprivation Therapy (ADT) together with the medication Nubeqa® for no more than 12 weeks before being randomly assigned to a treatment group.
  • Show at least one PSMA‑positive cancer spot on a special scan called a PET/CT using either 68Ga‑PSMA‑11 or 18F‑PSMA‑1007, with the scan done within 28 days before randomisation. PSMA‑positive means the spot lights up brighter than the liver (or spleen, depending on the scan) according to the VISION criteria.
  • Have at least one documented metastatic (spread) lesion in bone, soft tissue, or an organ (viscera) confirmed by standard imaging within 28 days before randomisation. This can be:
    • A bone metastasis seen on a bone scan,
    • Lymph node metastasis (if these are the only spots, at least one node must be 1.5 cm or larger and located outside the pelvis),
    • Visceral metastasis (any size) in an organ such as the liver or lungs. Even if a visceral spot disappeared before treatment, it is still counted.
    • Have an ECOG Performance Status of 0, 1, or 2, meaning you are fully active (0) or able to care for yourself and up to some limited activity (1‑2).
    • Show adequate blood‑forming (bone marrow) function: white blood cells (ANC) at least 1.5 × 10⁹/L, platelets at least 100 × 10⁹/L, and hemoglobin at least 9 g/dL.
    • Show adequate liver function: total bilirubin no more than 2 times the normal upper limit (up to 3 times if you have Gilbert’s syndrome), and liver enzymes ALT and AST no more than 3 times the normal limit (up to 5 times if you have liver metastases).
    • Show adequate kidney function with an estimated glomerular filtration rate (eGFR) of at least 50 mL/min/1.73 m², calculated by the MDRD formula.
    • Have a blood albumin level of at least 2.5 g/dL, indicating sufficient protein status.

Who cannot join the trial?

27 criteria

  • Having a tumor that is growing very quickly and needs urgent treatment with taxane‑based chemotherapy (a type of strong cancer‑killing medicine).
  • Having another advanced or spreading cancer that could change life expectancy or make it hard to judge the study results, unless that other cancer was treated successfully and you have been cancer‑free for at least three years (examples: non‑melanoma skin cancer or superficial bladder cancer).
  • Having serious other health problems at the same time, such as an uncontrolled infection, active hepatitis B or C (viral liver infections), or an active COVID‑19 infection (you must be fully recovered before joining).
  • Having significant heart disease, including:
    • Severe heart failure (NYHA class 3 or 4) within the last six months unless your heart function has improved (ejection fraction > 45%).
    • Serious heart rhythm problems seen on an ECG, such as sustained ventricular tachycardia, complete left bundle branch block, high‑grade AV block, or a family history of long QT syndrome (a condition that can cause dangerous heart rhythms).
    • A heart attack, chest pain (angina), or heart bypass surgery within the last six months.
    • A history of mental or psychiatric illness that could interfere with following the study procedures.
    • Signs or symptoms of spinal cord compression (pressure on the spinal cord) or evidence that it might happen soon.
    • Any condition that makes it impossible to raise your arms (required for certain study tests).
    • Severe bladder blockage or uncontrolled urinary leakage that cannot be managed with standard treatments.
    • Being a sexually active man who does not agree to use a condom during treatment and for 14 weeks after stopping, and who would not avoid donating sperm during that time.
    • Being unable to swallow pills or oral medication.
    • Lacking the legal ability to understand the study’s purpose, risks, and requirements.
    • Having received any previous systemic prostate cancer therapy (except the specific drugs listed in the study), such as chemotherapy, PARP inhibitors, immunotherapy, biological medicines (including monoclonal antibodies), or radiation therapy.
    • Being allergic (hypersensitive) to darolutamide, the active ingredient in Pluvicto®, or any of the listed inactive ingredients (e.g., lactose, magnesium stearate, titanium dioxide).
    • Having a current or past problem with abusing medication, drugs, or alcohol.
    • Being in a dependent relationship or employment relationship with the study sponsor or the investigator.
    • Being unable to refrain from donating blood or sperm while taking part in the study.
    • Having a screening PET/CT scan that shows a PSMA‑negative lesion that meets any of these size rules:
      • Lymph node 2.5 cm or larger.
      • Bone metastasis with a soft‑tissue part 1 cm or larger.
      • Metastasis in an organ such as liver or lung that is 1 cm or larger.
      • Having had any radiation treatment to the pelvic area before.
      • Receiving any other cancer‑killing treatments at the same time, such as chemotherapy, immunotherapy, radioligand therapy, PARP inhibitors, biological therapy, or any experimental drug.
      • Having received any of the following radioactive medicines within the last six months: Strontium‑89, Samarium‑153, Rhenium‑186, Rhenium‑188, Radium‑223, or hemi‑body irradiation, or any previous PSMA‑targeted radioligand therapy.
      • Being enrolled in another clinical trial that involves a medicinal treatment.
      • Receiving a blood transfusion only to become eligible for this study.
      • Having brain or spinal (CNS) metastases that are unstable, causing symptoms, or require steroids to keep the nervous system stable.
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Investigated drugs

  • Pluvicto

    is a targeted radiotherapy that is given through an IV. It contains a special radioactive substance that seeks out prostate cancer cells and delivers radiation directly to them. In this study, Pluvicto is added to the usual treatments to see if it helps shrink tumors and lower the PSA blood test result.

  • Nubeqa

    is an oral medicine that blocks the effect of male hormones on prostate cancer cells. By stopping these hormones from helping the cancer grow, Nubeqa works together with other treatments to control the disease. In the trial, patients continue taking Nubeqa as part of their standard care.

  • Androgen Deprivation Therapy (ADT)

    lowers the level of testosterone in the body, which prostate cancer cells need to grow. This is usually done with hormone‑blocking drugs or surgery. In the study, ADT is given to all participants as part of the standard treatment plan, and the researchers are testing whether adding Pluvicto provides extra benefit.

What is already known about the treatment

Pluvicto 1 000 MBq/mL solution for injection/infusion - This medication is a clear liquid that is given by intravenous infusion, meaning it is slowly injected directly into a vein. It is an FDA‑approved radiopharmaceutical that has been widely studied for metastatic castration‑resistant prostate cancer and is now being tested in hormone‑sensitive disease, with many research papers describing its use. The drug is used for men whose prostate cancer has spread to bone or other organs, together with standard hormone therapy. It works by attaching a tiny peptide that seeks out the PSMA protein on prostate‑cancer cells, delivering the radioactive atom lutetium‑177 which emits radiation that destroys those cells, and it is classified as a PSMA‑targeted radiopharmaceutical.

Investigated diseases

Metastatic hormone-sensitive prostate cancer - Metastatic hormone-sensitive prostate cancer is a form of prostate adenocarcinoma that continues to respond to androgen deprivation therapy. At diagnosis, cancer cells have already spread to bone, soft tissue, or visceral organs, indicating synchronous metastasis. Over time the disease can progress to involve additional metastatic sites and may eventually lose sensitivity to hormonal control.
Trial detailsLast updated 17 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-525520-20-00Protocol codeP003959Estimated enrolment72 patientsSponsorMedical Center - University Of Freiburg

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