A Phase 3 interventional study of BNT324 and Docetaxel in Metastatic Castration-resistant Prostate Cancer, sponsored by BioNTech SE. Recruiting at 52 sites in 7 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by BioNTech SE · Phase 3, Interventional, and Treatment
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:
The study consists of a screening period (up to 28 days), a treatment period with 21-day cycles, and an after-treatment period that includes a 30-day safety follow-up period and a long-term survival follow-up period.
Treatment continues until the cancer clearly gets worse (in scans, based on blinded independent central review [BICR] assessment or investigator's decision), side effects become unacceptable, the participant chooses to stop, or the study ends.
Participants are put into one of two groups in a 1:1 ratio, which means they will have an equal chance to be in either treatment group, i.e., BNT324 group, or docetaxel plus prednisone/prednisolone group (current SoC). An independent committee will help ensure participant safety, by regularly reviewing safety and early results.
For each participant, the treatment and follow-up periods are projected to be up to \~58 months.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 736 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →BioNTech SE is the lead sponsor of 76 studies on the registry; 25 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 26 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Must have documented progressive prostate cancer based on at least one of the following criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: BNT324
Drug: Docetaxel · Drug: Prednisone/prednisolone
Intravenous infusion
Also known as: DB-1311
Intravenous infusion
Drug pages: Prednisone · Prednisolone
Oral
rPFS assessed by BICR
By arm. rPFS is defined as time from randomization to radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria, or death from any cause, whichever occurs first.
Time frame: From randomization to end of study, i.e., up to 58 months
OS
By arm. OS is defined as time from randomization to death from any cause.
Time frame: From randomization to end of study, i.e., up to 58 months
Time to first subsequent therapy (TFTS)
By arm. TFST is defined as time from randomization to initiation of the first subsequent systemic anticancer therapy or death, whichever occurs first.
Time frame: From randomization to end of study, i.e., up to 58 months
Objective response rate (ORR)
By arm. ORR is defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per PCWG3-modifed RECIST v1.1 as assessed by BICR) is observed as best overall response.
Time frame: From randomization to end of study, i.e., up to 58 months
Duration of response (DOR)
By arm. DOR is defined as time from first objective response (confirmed CR or PR per PCWG3-modified RECIST v1.1 criteria as assessed by BICR) to first occurrence of objective tumor progression (progressive disease per PCWG3-modified RECIST v1.1 criteria as assessed by BICR) or death from any cause, whichever occurs first.
Time frame: From randomization to end of study, i.e., up to 58 months
Time to pain progression (TTPP)
By arm. TTPP is defined as time from randomization to pain progression as determined by Brief Pain Inventory-Short Form Item 3 "worst pain in 24 hours" and opiate analgesic use (Analgesic Quantification Algorithm score).
Time frame: From randomization to safety follow-up visit (30 days after the last dose), i.e., up to 58 months
rPFS as assessed by investigator
By arm. rPFS is defined as time from randomization to radiographic disease progression per PCWG3-modified RECIST v1.1 criteria, or death from any cause, whichever occurs first.
Time frame: From randomization to end of study, i.e., up to 58 months
Time to first symptomatic skeletal-related event (SSRE)
By arm. Time to first SSRE is defined as time from randomization to first occurrence of any of the following SSREs: * Use of external beam radiation therapy to prevent or relieve skeletal symptoms. * New symptomatic pathologic bone fracture (vertebral or non-vertebral). * Spinal cord compression. * Tumor-related orthopedic surgical intervention.
Time frame: From randomization to end of study, i.e., up to 58 months
Time to prostate-specific antigen (PSA) progression (by central lab testing results)
By arm. Time to PSA progression is defined as time from randomization to PSA progression per PCWG3 criteria.
Time frame: From baseline to end of treatment visit, i.e., up to 58 months
PSA response (by central lab testing results)
By arm. PSA response is defined as having a post-baseline PSA reduction ≥50% from baseline with a consecutive confirmation assessment at least 3 weeks later per PCWG3 criteria.
Time frame: From baseline to end of treatment visit, i.e., up to 58 months
Number and percentage of participants with treatment-emergent adverse events (TEAEs) including Grade ≥3, serious, and fatal TEAEs
TEAEs by relationship and by arm.
Time frame: From the start of study treatment until 30 days after the last dose of study treatment or until start of new systemic anticancer therapy, whichever occurs first, i.e., up to 58 months
Number and percentage of participants with dose interruptions, reductions or discontinuations of study treatment due to TEAEs
By arm.
Time frame: From the start of study treatment until 30 days after the last dose of study treatment or until start of new systemic anticancer therapy, whichever occurs first, i.e., up to 58 months
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Feb 2031, 58 months after the start.
Of 126 industry-sponsored phase 3 interventional studies under Prostatic Neoplasms, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 53. This study's planned 58 months is above that.
Counting every sponsor, half of 265 studies reached it within 57 months; a quarter within 31 and three quarters within 100.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Elfetabart Drozuntecan