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.
Plain-language title generated from the registry record
Registry title: A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer
Key facts
- Where
- Candiolo, Foggia, Genoa, Lecce, Meldola, Milan, Pisa, Rozzano, and Verona, ItalySee the 9 sites
- Phase
- Phase 3
Where in Italy
- 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
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BioNTech SE
- Trial code
- NCT07365995EU 2025-524445-27-00
- Record updated
- 16 October 2026
- Original description
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
A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer
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.
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]).
Inclusion: 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.
Exclusion: 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.