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Study on Treating Metastatic Castration-Resistant Prostate Cancer with 177Lu-PNT2002 Compared to Abiraterone or Enzalutamide for Patients After Hormonal Therapy

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 a type of prostate cancer known as metastatic castration-resistant prostate cancer (mCRPC). This is a form of prostate cancer that continues to grow and spread even when the amount of testosterone in the body is reduced to very low levels. The study is evaluating the effectiveness of a treatment called 177Lu-PNT2002, which is a solution for injection, compared to two other medications, abiraterone and enzalutamide, which are taken as film-coated tablets. These treatments are being tested to see how well they can delay the progression of the cancer as seen on medical imaging.

The purpose of the study is to determine if 177Lu-PNT2002 is more effective than the other two medications in slowing down the spread of the cancer. Participants in the study will receive one of these treatments, and some may receive a placebo. The study will involve regular check-ups and imaging tests to monitor the cancer's response to the treatment. The treatment period for 177Lu-PNT2002 is up to 24 weeks, while the other medications are taken for up to 28 days at a time. The study aims to provide valuable information on which treatment option may offer the best outcomes for patients with this type of prostate cancer.

Throughout the study, participants will be closely monitored for any changes in their condition and any side effects they may experience. The study will also track how long patients live after starting the treatment and any improvements in their symptoms. This research is important for finding better ways to manage and treat metastatic castration-resistant prostate cancer, offering hope for improved care and outcomes for those affected by this challenging condition.

The research process

The trial runs in 7 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, eligibility is confirmed based on specific criteria, including age, medical history, and current health status.

    Informed consent is required, ensuring understanding of the study's purpose and procedures.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups: Treatment Arm A or Treatment Arm B.

    This process ensures that each participant has an equal chance of receiving either treatment.

  3. Step 3

    Treatment arm a: 177Lu-PNT2002

    Participants in Treatment Arm A receive 177Lu-PNT2002, a therapy administered through an intravenous injection.

    The frequency and duration of this treatment are determined by the study protocol and medical assessments.

  4. Step 4

    Treatment arm b: abiraterone or enzalutamide

    Participants in Treatment Arm B receive either abiraterone or enzalutamide, both of which are oral medications.

    The specific medication is preselected by the investigator, and the dosage and frequency are based on standard medical guidelines.

  5. Step 5

    Monitoring and assessments

    Regular monitoring is conducted to assess the treatment's effectiveness and any potential side effects.

    This includes imaging tests, blood tests, and other evaluations as specified in the study protocol.

  6. Step 6

    End of treatment

    The treatment phase concludes based on the study's timeline or if specific criteria are met, such as disease progression or adverse effects.

    Participants may undergo final assessments to evaluate the overall impact of the treatment.

  7. Step 7

    Follow-up

    After the treatment phase, follow-up visits are scheduled to monitor long-term effects and overall health.

    These visits help gather additional data on the treatment's efficacy and safety.

Who can join the trial?

17 criteria

  • Must be a male aged 18 years or older.
  • Must have a confirmed diagnosis of prostate cancer that has spread to other parts of the body and is resistant to standard hormone therapy.
  • Must not be eligible for or willing to undergo chemotherapy.
  • Must have signs of cancer progression, such as an increase in PSA levels, growth of existing tumors, or new bone lesions.
  • Must have previously been treated with one type of advanced hormone therapy, such as abiraterone or enzalutamide, and shown progression.
  • Must have a positive result on a special scan called a PSMA-PET scan, which helps to detect prostate cancer cells.
  • Must have low levels of testosterone, which is a male hormone.
  • Must have adequate organ function, meaning the body’s organs are working well enough to participate in the study. This includes:
    • Bone marrow: Sufficient white blood cells, platelets, and hemoglobin.
    • Liver: Normal levels of bilirubin and liver enzymes.
    • Kidneys: Normal creatinine levels or a certain level of kidney function.
    • Albumin: A protein level in the blood that is within a normal range.
    • Must use a condom and another effective birth control method if their partner is pregnant or can become pregnant, during the study and for 6 months after the last dose of the study drug.
    • Must be willing to start a specific hormone therapy if assigned to that treatment group.
    • Must have a good performance status, meaning they are able to carry out daily activities with little or no assistance.
    • Must be willing and able to follow all study requirements and treatments, including the timing and nature of required assessments.
    • Must provide signed informed consent, which means they agree to participate in the study after being informed about all aspects of it.
    • Patients with HIV can participate if they are healthy and have a low risk of complications related to their HIV status.

Who cannot join the trial?

4 criteria

  • Patients who do not have metastatic castration-resistant prostate cancer (mCRPC) cannot participate. This is a type of prostate cancer that has spread to other parts of the body and does not respond to treatments that lower testosterone.
  • Patients who have not previously been treated with ARAT (Androgen Receptor Axis-Targeted therapies) are excluded. These are treatments that target the male hormones that can fuel prostate cancer growth.
  • Only male patients are eligible, so female patients cannot participate.
  • Patients who are considered part of a vulnerable population, such as those unable to give informed consent, are not eligible.
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Investigated drugs

  • 177Lu-PNT2002

    is a type of targeted radiotherapy used in the treatment of metastatic castrate-resistant prostate cancer. It works by delivering radiation directly to cancer cells, helping to slow down or stop their growth. This therapy is being evaluated for its effectiveness in delaying the progression of the disease after patients have already received hormonal treatments.

  • Abiraterone

    is a medication used to treat prostate cancer by reducing the production of androgens, which are hormones that can promote the growth of cancer cells. It is often used after other treatments have been tried and is being compared in this study to see how well it works in delaying cancer progression.

  • Enzalutamide

    is another medication used in the treatment of prostate cancer. It works by blocking the effects of androgens on the cancer cells, which can help to slow down or stop the growth of the cancer. This study is comparing its effectiveness to other treatments in delaying the progression of the disease.

What is already known about the treatment

177Lu-PNT2002 – This medication is administered through intravenous infusion and is currently being studied in clinical trials for its effectiveness in treating metastatic castration-resistant prostate cancer (mCRPC). It is a radioligand therapy that targets prostate-specific membrane antigen (PSMA) on cancer cells, delivering a radioactive payload directly to the tumor, which helps to destroy cancer cells. This medication is classified as a targeted radiopharmaceutical therapy and is being evaluated for its ability to delay disease progression in patients who have not responded to second-line hormonal treatments.

Investigated diseases

Metastatic Castration-Resistant Prostate Cancer (mCRPC) – This is a type of prostate cancer that continues to grow and spread to other parts of the body despite treatments that lower testosterone levels. It is characterized by cancer cells that have adapted to survive in a low-testosterone environment, making them resistant to traditional hormone therapy. The disease often progresses by spreading to bones and other organs, leading to symptoms such as pain and fractures. Over time, the cancer may become more aggressive and difficult to manage. The progression of mCRPC is typically monitored through imaging tests and blood markers like PSA levels.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515604-39-00Protocol codePBP-301Estimated enrolment455 patientsSponsorPoint Biopharma Inc.

sourced from the EU Clinical Trials Register and site verification

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