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Study on Lutetium (177Lu) Vipivotide Tetraxetan and Androgen Receptor Inhibitors for Patients with Castration-Resistant Prostate Cancer

Fast replyRegistered 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 a type of prostate cancer known as castration-resistant prostate cancer (CRPC), which is resistant to treatments that lower testosterone. The study will explore the effects of a treatment called lutetium [177Lu] vipivotide tetraxetan, also known as AAA617. This treatment will be tested both on its own and in combination with other medications called androgen receptor pathway inhibitors, which include drugs like apalutamide, darolutamide, and enzalutamide. These medications work by blocking the effects of male hormones that can promote cancer growth.

The purpose of the study is to evaluate how well these treatments work in reducing prostate-specific antigen (PSA) levels, which are markers used to monitor prostate cancer. Participants will receive either the AAA617 treatment alone or in combination with the androgen receptor pathway inhibitors. The study will involve regular monitoring of PSA levels and other health indicators over a period of time to assess the effectiveness of the treatments.

Participants will be selected based on specific criteria, including having a positive result on a PSMA PET scan, which is a type of imaging test that helps to identify prostate cancer cells. The study will be conducted over several years, with participants receiving treatment and undergoing regular assessments to track their response to the therapy. The goal is to gather information that could lead to improved treatment options for patients with this type of prostate cancer.

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

    Joining the study

    Upon joining the study, participants must be adults aged 18 or older with confirmed prostate cancer. Participants must have ongoing treatment to lower testosterone levels, either through medication or surgery.

    Participants must show evidence of prostate cancer that is visible on a specific type of scan called a PSMA PET scan. This scan helps to identify cancer that has spread beyond the prostate.

  2. Step 2

    Randomization and treatment assignment

    Participants are randomly assigned to receive either lutetium (177Lu) vipivotide tetraxetan alone or in combination with androgen receptor pathway inhibitors. These inhibitors include medications such as apalutamide, darolutamide, enzalutamide, degarelix, and relugolix.

    The route of administration for these medications is primarily oral, except for lutetium (177Lu) vipivotide tetraxetan, which is given intravenously.

  3. Step 3

    Treatment administration

    Participants receive the assigned treatment according to the study protocol. The frequency and duration of administration depend on the specific medication and treatment plan.

    For example, lutetium (177Lu) vipivotide tetraxetan is administered as an injection or infusion, while other medications are taken orally.

  4. Step 4

    Monitoring and assessments

    Participants undergo regular monitoring to assess the response to treatment. This includes measuring prostate-specific antigen (PSA) levels, which help to evaluate the effectiveness of the treatment.

    Additional imaging tests, such as CT or MRI scans, may be conducted to check for any progression of the disease.

  5. Step 5

    Completion of the study

    The study is expected to continue until November 2028. Participants will be monitored throughout the study period to gather data on the effectiveness and safety of the treatments.

    The primary goal is to evaluate the response of PSA levels in participants receiving the treatments.

Who can join the trial?

8 criteria

  • Participants must be adults who are 18 years or older and have signed a consent form agreeing to participate in the study.
  • Participants must have prostate cancer confirmed by a test that looks at cells or tissues under a microscope.
  • Participants must be receiving ongoing androgen deprivation therapy, which is a treatment to lower male hormones, using a GnRH agonist/antagonist or have had a bilateral orchiectomy (surgical removal of both testicles).
  • Participants must have a castrate level of serum testosterone, meaning very low levels of testosterone in the blood, which is less than 1.7 nmol/l (50 ng/dl), while on GnRH therapy or after bilateral orchiectomy.
  • Participants must show evidence of PSMA-positive disease on a specific type of scan called a PET/CT scan at the start of the study. This will be reviewed by experts who are not aware of the participants' details. Participants with M1 disease (cancer that has spread to other parts of the body) only on this scan can join the study.
  • Participants must have a negative result on conventional imaging for M1 disease, meaning traditional scans do not show the disease has spread.
  • Participants must have a PSA Doubling Time of 10 months or less. This is a measure of how quickly the PSA level (a protein produced by the prostate) doubles in the blood.
  • Participants must have adequate organ functions, meaning their bone marrow, liver, and kidneys are working well enough to participate in the study.

Who cannot join the trial?

10 criteria

  • Participants must not have any other serious medical conditions that could interfere with the study.
  • Participants should not have any allergies to the study medications.
  • Participants must not be currently participating in another clinical trial.
  • Participants should not have a history of certain heart conditions, such as heart attack or heart failure.
  • Participants must not have any active infections that require treatment.
  • Participants should not have any uncontrolled high blood pressure.
  • Participants must not have any liver or kidney problems that are severe.
  • Participants should not have any other types of cancer that are not under control.
  • Participants must not have any mental health conditions that could affect their ability to participate in the study.
  • Participants should not have any recent surgeries that could impact their health during the study.
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Investigated drugs

  • AAA617

    is a medication being studied for its effects on prostate cancer. It is a type of radiopharmaceutical therapy that targets cancer cells using a radioactive substance. This medication is designed to bind to specific proteins on the surface of prostate cancer cells, allowing the radioactive component to deliver targeted radiation directly to the tumor, potentially reducing its size or slowing its growth.

  • Androgen Receptor Pathway Inhibitors (ARPI)

    are a group of medications used in this study to help treat prostate cancer. These medications work by blocking the effects of androgens, which are male hormones that can promote the growth of prostate cancer cells. By inhibiting these hormones, ARPIs aim to slow down or stop the progression of the cancer. In this trial, ARPIs are used in combination with AAA617 to assess their combined effectiveness in treating prostate cancer.

What is already known about the treatment

Lutetium [177Lu] vipivotide tetraxetan – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating castration-resistant prostate cancer that is positive on a PSMA PET scan. It is in the phase II stage of clinical trials, indicating that it is still under investigation but has shown promise in earlier studies. The main therapeutic indication is for prostate cancer that has not responded to traditional hormone therapy. At the molecular level, it works by delivering targeted radiation to cancer cells, which express the PSMA protein, thereby damaging and killing these cells. It is classified as a radiopharmaceutical, which is a type of drug that contains radioactive substances used to treat cancer.

Investigated diseases

Castration-Resistant Prostate Cancer (CRPC) – This is a type of prostate cancer that continues to progress despite the reduction of male hormones that fuel the growth of prostate cancer cells. It is characterized by the cancer's ability to grow even when the amount of testosterone in the body is reduced to very low levels. The disease often spreads to other parts of the body, such as bones and lymph nodes. Patients with CRPC may experience an increase in prostate-specific antigen (PSA) levels, indicating cancer progression. The condition is typically identified through imaging tests that reveal the spread of cancer to bones or soft tissues. CRPC is a challenging condition as it does not respond to traditional hormone therapy used in earlier stages of prostate cancer.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-503040-41-00Protocol codeCAAA617B12203Estimated enrolment50 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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