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Phase III Randomized Open‑Label Trial of BNT324 vs Docetaxel Plus Prednisone in Patients with Metastatic Castration‑Resistant 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

Metastatic castration-resistant prostate cancer is a form of prostate cancer that has spread beyond the prostate and continues to grow even when testosterone levels are low. The study evaluates two treatment approaches: an intravenous medication called BNT324 and a chemotherapy drug called docetaxel given together with oral prednisone.

The purpose of the study is to compare how well BNT324 works against docetaxel in slowing disease progression and extending survival. Participants are randomly assigned to one of the two groups and receive the assigned medication in cycles, typically every three weeks, with treatment continuing until the disease worsens, side effects become too severe, or the planned treatment period ends.

During the trial, patients undergo regular imaging scans to check for changes in tumor size, blood tests to monitor prostate‑specific antigen levels, and assessments of pain and overall health. The study records how long the cancer remains stable, the time until death from any cause, and any side effects experienced.

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

    Randomization to treatment arm

    After enrollment, you will be assigned by chance to one of two groups. one group receives bnt324 and the other receives docetaxel together with prednisone. the assignment is called randomization.

  2. Step 2

    Start of study medication

    The first dose of the medication assigned to you is given shortly after randomization. bnt324 is given by intravenous infusion at a dose of 6 mg per kilogram of body weight. docetaxel is given by intravenous infusion at a dose of 75 mg per square meter of body‑surface area, and prednisone is taken by mouth at 10 mg each day.

  3. Step 3

    Regular infusion visits

    You will return to the clinic for each infusion according to the schedule defined by the study protocol. during each visit, the assigned intravenous medication (bnt324 or docetaxel) is administered over a short period of time.

  4. Step 4

    Daily oral prednisone (docetaxel arm only)

    If you are in the docetaxel group, you will take prednisone 10 mg by mouth every day throughout the treatment period. the tablet is swallowed with water.

  5. Step 5

    Monitoring and safety assessments

    At each clinic visit, health care staff will check your vital signs, ask about any side effects, and may draw blood or perform imaging tests to see how the cancer is responding. these checks help determine whether the treatment is safe and effective.

  6. Step 6

    Dose adjustments or interruptions

    If side effects become severe, the study doctor may lower the dose, pause treatment for a short time, or stop the medication altogether. any change follows the study’s rules for managing adverse events.

  7. Step 7

    Continuation of treatment

    Treatment continues until one of the following occurs: the cancer shows growth on scans, side effects are unacceptable, or the doctor decides to stop treatment for any other reason. the total length of treatment is not fixed in advance and depends on your individual response.

  8. Step 8

    Post‑treatment follow‑up

    After the last dose of study medication, you will have follow‑up visits for up to 30 days. during this period, the team will continue to monitor for any late side effects and record any health changes.

Who can join the trial?

6 criteria

  • Be a man who is at least 18 years old.
  • Have prostate cancer that is getting worse, shown by either a rise in the blood test called PSA (two higher numbers at least one week apart, with the level at screening being 1.0 ng/mL or more), a growth of soft‑tissue tumors seen on scans using the PCWG3‑modified RECIST v1.1 rules, or new bone lesions seen on a bone scan following PCWG3 criteria.
  • Have already taken one or two medicines that block the androgen receptor pathway (drugs that lower the effect of male hormones) and the cancer must have continued to grow after at least eight weeks of that treatment.
  • Must not have received any systemic cytotoxic chemotherapy (drugs that kill dividing cells), including taxane‑based chemotherapy, for metastatic castration‑resistant prostate cancer.
  • Must have had a surgical removal of the testicles (orchiectomy) or be on ongoing hormone‑lowering therapy that keeps testosterone at a very low “castrate” level (<50 ng/dL or <1.7 nmol/L). If you are using medicines called luteinizing hormone‑releasing hormone (LHRH) agonists or antagonists, you must keep taking them during the study.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1, meaning you are fully active (0) or able to carry out light work (1).

Who cannot join the trial?

3 criteria

  • You have already been treated with a medicine that targets B7‑H3, including any drug called a B7‑H3 ADC (an antibody‑drug conjugate that delivers chemotherapy directly to cancer cells).
  • You have uncontrolled or serious heart or blood‑vessel disease (known as cardiovascular disease), meaning your heart or circulation problems are not well managed.
  • You have a past or present history of non‑infectious interstitial lung disease (ILD) or pneumonitis (a type of lung inflammation) that needed treatment with steroids, or you currently have these lung conditions.
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Investigated drugs

  • Prednisone/Prednisolone

    is a steroid medication taken by mouth. In this study it is used as a standard treatment that helps reduce inflammation and can help control some symptoms of prostate cancer. It is given to patients in the same way as in everyday practice, so doctors can compare the new drug against this familiar therapy.

  • Docetaxel

    is a chemotherapy drug that is given through an IV (a needle placed in a vein). It works by stopping cancer cells from growing and dividing. In the trial, docetaxel is the current standard chemotherapy for advanced prostate cancer, and it serves as the comparison point for the new treatment.

  • BNT324

    is an experimental medicine that is being tested for the first time in this type of prostate cancer. It is given as a powder that is mixed and infused into a vein. The drug is designed to target the cancer cells in a different way than chemotherapy, and the trial is looking to see if it can keep the disease from getting worse and help patients live longer.

What is already known about the treatment

  • Prednisone

    It is taken by mouth as a tablet, usually 10 mg once daily. Prednisone is an approved corticosteroid that has been used for many decades to treat inflammation and to suppress the immune system. It is commonly used in prostate cancer together with chemotherapy to help reduce side effects and improve appetite. It works by binding to glucocorticoid receptors, which then change the activity of genes that control inflammation.

  • Docetaxel

    It is given by intravenous infusion, typically 75 mg per square meter of body‑surface area every three weeks. Docetaxel is a standard chemotherapy drug that is fully approved for many cancers, including metastatic prostate cancer. It belongs to the taxane class and works by stopping cancer cells from dividing, interfering with the structure that pulls chromosomes apart. This leads to cell death and helps shrink tumors.

  • BNT324

    It is administered as an intravenous infusion of a powder that is mixed into a solution, given at 6 mg per kilogram of body weight. BNT324 is an experimental drug that is still being studied in clinical trials for prostate cancer. It is a targeted therapy that blocks a specific protein that helps cancer cells grow and spread. By inhibiting this protein, the drug aims to stop tumor growth and improve survival.

Investigated diseases

Metastatic castration‑resistant prostate cancer (mCRPC) - This is prostate cancer that keeps growing even after hormone therapy has lowered testosterone to very low levels. The disease has spread beyond the prostate gland to bones, lymph nodes, or other organs. Cancer cells continue to divide and form new tumor sites, which can be seen on scans or indicated by rising PSA levels. As the cancer advances, the number and size of metastatic lesions may increase, leading to worsening symptoms such as bone pain. The condition is monitored by imaging studies and blood tests to track disease activity.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524445-27-00Protocol codeBNT324-03Estimated enrolment693 patientsSponsorBioNTech SE

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