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Metastatic Castration-resistant Prostate CancerPhase 3NCT07365995

A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer

A Phase 3 study testing BNT324, Docetaxel and Prednisone/prednisolone in people with Metastatic Castration-resistant Prostate Cancer, run by BioNTech SE at 52 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
BNT324, Docetaxel and Prednisone/prednisolone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
736 participants
Where
52 sitesin 7 countries
Study dates
22 Apr 2026to Feb 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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 join

  • 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.

Trial locations and contacts

52 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

BioNTech clinical trials patient information contact

+49 6131 9084 ext. 0

patients@biontech.de

52 sites in 7 countries

United States21 sites, 21 recruiting

  • NYOH Albany Cancer Center

    Albany, New York, 12206

    Recruiting

  • Piedmont Cancer Institute

    Atlanta, Georgia, 30318

    Recruiting

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

    Recruiting

  • Texas Oncology South Austin

    Austin, Texas, 78731

    Recruiting

  • Oncology/Hematology Care, Inc.

    Cincinnati, Ohio, 45242

    Recruiting

  • Virginia Cancer Specialists PC

    Fairfax, Virginia, 22031

    Recruiting

  • Florida Cancer Specialists- Fort Myers

    Fort Myers, Florida, 33901

    Recruiting

  • Texas Oncology Gulf Coast

    Houston, Texas, 77024

    Recruiting

  • START Carolinas

    Myrtle Beach, South Carolina, 29572

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Recruiting

  • Tennessee Oncology

    Nashville, Tennessee, 37203

    Recruiting

  • Illinois Cancer Specialists

    Niles, Illinois, 60714

    Recruiting

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

    Recruiting

  • Illinois CancerCare PC

    Peoria, Illinois, 61615

    Recruiting

  • Maryland Oncology Hematology

    Rockville, Maryland, 20850

    Recruiting

  • Sansum Clinic

    Santa Barbara, California, 93105

    Recruiting

  • Florida Cancer Specialists- St. Petersburg

    St. Petersburg, Florida, 33701

    Recruiting

  • Texas Oncology, P.A. - Tyler

    Tyler, Texas, 75702

    Recruiting

  • Florida Cancer Specialists- West Palm Beach

    West Palm Beach, Florida, 33401

    Recruiting

  • White Plains Hospital

    White Plains, New York, 10601

    Recruiting

  • Texas Oncology - West Texas

    Wichita Falls, Texas, 76310

    Recruiting

Other trials in United States

China18 sites, 18 recruiting

  • Peking University First Hospital

    Beijing, 100034

    Recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

    Recruiting

  • The First Affiliated Hospital of Hunan Normal University

    Changsha, 410005

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, 610041

    Recruiting

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, 400072

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, 350001

    Recruiting

  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    Hangzhou, 310016

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

    Recruiting

  • Second Hospital of Anhui Medical University

    Hefei, 230601

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330006

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

    Recruiting

  • Shanghai Cancer Center

    Shanghai, 200032

    Recruiting

  • No. 10 People's Hospital of Shanghai

    Shanghai, 200072

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

    Recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, 420104

    Recruiting

  • Hubei Cancer Hospital

    Wuhan, 430079

    Recruiting

  • Yijishan Hospital of Wannan Medical College

    Wuhu, 241001

    Recruiting

  • Yantai Yuhuangding Hospital

    Yantai, 264000

    Recruiting

Other trials in China

United Kingdom7 sites, 7 recruiting

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

    Recruiting

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

    Recruiting

  • St James's University Hospital

    Leeds, LS9 7TF

    Recruiting

  • Royal Marsden Hospital

    London, SW3 6JJ

    Recruiting

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

    Recruiting

  • Southampton General Hospital

    Southampton, SO16 6YD

    Recruiting

  • Royal Marsden Hospital

    Sutton, SM2 5PT

    Recruiting

Other trials in United Kingdom

Germany2 sites, 2 recruiting

  • Universitätsklinikum Carl Gustav Carus

    Dresden, 1307

    Recruiting

  • Asklepios Klinik Altona

    Hamburg, 22763

    Recruiting

Other trials in Germany

Poland2 sites, 2 recruiting

  • Pratia MCM Krakow

    Krakow, 30-727

    Recruiting

  • National Research Institute of Oncology - National Research Institute (NIO-PIB)

    Warsaw, 02-781

    Recruiting

Other trials in Poland

Australia1 site, 1 recruiting

  • Tasman Onco Research Pty Ltd

    Southport, 4215

    Recruiting

Other trials in Australia

Belgium1 site, 1 recruiting

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

    Recruiting

Other trials in Belgium

About this study

Official title: 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]).
Read the detailed description

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.

Being tested
BNT324, Docetaxel, Prednisone/prednisolone
Keywords
Immunotherapy, Antibody-drug conjugate (ADC), Standard of care (SoC), Chemotherapy, Steroids, BNT324 (DB-1311), mCRPC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BNT324Drug

    Also called DB-1311

    Intravenous infusion

  • DocetaxelDrug

    Intravenous infusion

  • Prednisone/prednisoloneDrug

    Oral

Study groups in NCT07365995
Study groupRoleWhat they receive
BNT324ExperimentalNot described
Receives: Drug: BNT324
Docetaxel plus prednisone/ prednisoloneActive comparatorNot described
Receives: Drug: Docetaxel; Drug: Prednisone/prednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From randomization to end of study, i.e., up to 58 months

  2. OS

    By arm. OS is defined as time from randomization to death from any cause.

    Measured: From randomization to end of study, i.e., up to 58 months

Secondary outcomes (10)

  1. 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.

    Measured: From randomization to end of study, i.e., up to 58 months

  2. 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.

    Measured: From randomization to end of study, i.e., up to 58 months

  3. 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.

    Measured: From randomization to end of study, i.e., up to 58 months

  4. 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).

    Measured: From randomization to safety follow-up visit (30 days after the last dose), i.e., up to 58 months

  5. 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.

    Measured: From randomization to end of study, i.e., up to 58 months

  6. 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.

    Measured: From randomization to end of study, i.e., up to 58 months

  7. 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.

    Measured: From baseline to end of treatment visit, i.e., up to 58 months

  8. 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.

    Measured: From baseline to end of treatment visit, i.e., up to 58 months

  9. Number and percentage of participants with treatment-emergent adverse events (TEAEs) including Grade ≥3, serious, and fatal TEAEs

    TEAEs by relationship and by arm.

    Measured: 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

  10. Number and percentage of participants with dose interruptions, reductions or discontinuations of study treatment due to TEAEs

    By arm.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2026
  2. Study start22 Apr 2026
  3. Primary completionFeb 2031 (estimated)
  4. Study completionFeb 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
736 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07365995
Sponsor's protocol ID
BNT324-03
Other IDs
2025-524445-27-00, 2025
Status last verified
Oct 2026
First submitted
23 Jan 2026
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BNT324, Docetaxel and Prednisone/prednisolone in people with Metastatic Castration-resistant Prostate Cancer, run by BioNTech SE at 52 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, China, United Kingdom, Germany, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BioNTech clinical trials patient information (+49 6131 9084 ext. 0, patients@biontech.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rPFS assessed by BICR (time frame: From randomization to end of study, i.e., up to 58 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07365995.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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