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Taking people in ItalyPhase 3

BNT324 compared with docetaxel for metastatic castration-resistant prostate cancer

Compares BNT324 with docetaxel in men whose advanced prostate cancer persists despite hormone-blocking treatment.

Key facts

Who runs it
BioNTech SE
Where
Candiolo, Foggia, Genoa, Lecce, Meldola, Milan, Pisa, Rozzano, and Verona, ItalySee the 9 sitesAlso in 9 other countries, 90 sites
Registry title
A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer
Status
Recruiting
Phase
Phase 3
People taking part
736 people, planned
Started
22 Apr 2026
Expected to end
Feb 2031
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • BNT324
  • Docetaxel
  • Prednisone/prednisolone
Record updated
16 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men with prostate cancer that has spread and no longer responds to hormone-lowering treatment. They must have had a hormone-blocking pill (an androgen receptor pathway inhibitor) but no taxane chemotherapy for this stage.

Age
18 years or older
Sex
Men only
Disease stage
Metastatic castration-resistant prostate cancer that is getting worse, shown by rising PSA (at least 1.0 ng/mL at screening), growth on scans, or progression of bone disease. Performance score of 0 or 1.
Earlier treatment
Must have had one or two androgen receptor pathway inhibitor treatments, with progression after at least 8 weeks of therapy. Must not have had chemotherapy, including taxane chemotherapy, for metastatic castration-resistant prostate cancer. Must have had testicle removal surgery or ongoing androgen-deprivation therapy with a low testosterone level (below 50 ng/dL).
Biomarker or test result
Testosterone at castrate level (below 50 ng/dL or below 1.7 nmol/L). PSA at screening of at least 1.0 ng/mL if the cancer is shown by PSA progression.

Main reasons for not taking part

  • Earlier treatment with B7-H3 targeted therapy, including B7-H3 ADCs
  • Uncontrolled or significant heart or blood vessel disease, as defined in the protocol
  • Past non-infectious interstitial lung disease or pneumonitis that needed steroids
  • Current interstitial lung disease or pneumonitis
  • Earlier chemotherapy with a taxane for this stage of prostate cancer

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • Are male adults (defined as ≥18 years of age or of an acceptable age according to local regulations at the time of giving informed consent)
  • Must have documented progressive prostate cancer based on at least one of the following criteria:; Serum/plasma PSA progression, by local laboratory, defined as two consecutive increases in PSA over a previous reference value, each measured sequentially at least 1 week apart. The PSA value at screening is required to be ≥1.0 ng/mL; Radiographic soft tissue progression as per PCWG3-modified RECIST v1.1; Radiographic progression of bone disease: evaluable disease or new bone lesion(s) by bone scan per PCWG3 criteria
  • Had previously received one or two prior androgen receptor pathway inhibitor treatments and experienced disease progression during or after a minimum of 8 weeks of therapy
  • Must not have received systemic cytotoxic chemotherapy, including taxane-based chemotherapy, for mCRPC
  • Must have had prior orchiectomy and/or have ongoing androgen-deprivation therapy and a castrate-level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L). Participant being treated with luteinizing hormone-releasing hormone agonists or antagonists must continue such treatment throughout the study
  • Must have an Eastern Cooperative Oncology Group performance score of 0 or 1

Who cannot take part

  • Have received prior treatment with B7-H3 targeted therapy, including B7-H3 ADCs
  • Have uncontrolled or significant cardiovascular disease, as defined in the protocol
  • Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids or have current ILD/pneumonitis; NOTE: Other protocol defined Inclusion/Exclusion criteria apply

Where in Italy

Also in 9 other countries, 90 sites

  • Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCSCandiolo, ItalyTaking people
  • Azienda Ospedaliero Universitaria Ospedali RiunitiFoggia, ItalyTaking people
  • IRCCS Azienda Ospedaliera MetropolitanaGenoa, ItalyTaking people
  • Ospedale Vito Fazzi LecceLecce, ItalyTaking people
  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyTaking people
  • Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyTaking people
  • Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
  • Humanitas Mirasole S.p.A.Rozzano, ItalyTaking people
  • Centro Ricerche Cliniche di Verona s.r.l.Verona, ItalyTaking people

About the trial

What the trial wants to find out

This study will test whether BNT324 is safe and works better against metastatic castration-resistant prostate cancer (mCRPC) than the current standard of care (SoC) chemotherapy, which is docetaxel (given together with the steroid medicines prednisone or prednisolone). The study will include participants with mCRPC that have been previously treated with androgen receptor pathway inhibitor, but with no previous taxane-based systematic chemotherapy for mCRPC.

Read full original descriptionShow less

The main goals of this study are:

* To find out if BNT324 helps participants live longer without their cancer getting worse (radiographic progression-free survival [rPFS]). * To find out if BNT324 helps participants live longer overall (overall survival [OS]).

The 2 groups in the trial

  • BNT324Treatment being tested
  • Docetaxel plus prednisone/ prednisoloneExisting treatment, for comparison

    Treatment: Docetaxel and Prednisone/prednisolone

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer
Plain-language title
BNT324 compared with docetaxel for metastatic castration-resistant prostate cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
16 October 2026