A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BNT324, Docetaxel, Prednisone/prednisolone.
- Who it may be relevant to
- Registry conditions: Metastatic Castration-resistant Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer
Overview
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 \[OS\]).
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.
Interventions
- Drug BNT324
Intravenous infusion - Drug Docetaxel
Intravenous infusion - Drug Prednisone/prednisolone
Oral
Primary outcome measures
- rPFS assessed by BICR [Time frame: From randomization to end of study, i.e., up to 58 months]
- OS [Time frame: From randomization to end of study, i.e., up to 58 months]
Secondary outcome measures (10)
- Time to first subsequent therapy (TFTS) [Time frame: From randomization to end of study, i.e., up to 58 months]
- Objective response rate (ORR) [Time frame: From randomization to end of study, i.e., up to 58 months]
- Duration of response (DOR) [Time frame: From randomization to end of study, i.e., up to 58 months]
- Time to pain progression (TTPP) [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 [Time frame: From randomization to end of study, i.e., up to 58 months]
- Time to first symptomatic skeletal-related event (SSRE) [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) [Time frame: From baseline to end of treatment visit, i.e., up to 58 months]
- PSA response (by central lab testing results) [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 [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 [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]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 15 centers
- Rocky Mountain Cancer Centers — Aurora
- Florida Cancer Specialists- Fort Myers — Fort Myers
- Florida Cancer Specialists- St. Petersburg — St. Petersburg
- Florida Cancer Specialists- West Palm Beach — West Palm Beach
- Illinois Cancer Specialists — Niles
- Illinois CancerCare PC — Peoria
- Maryland Oncology Hematology — Rockville
- Oncology/Hematology Care, Inc. — Cincinnati
- … and 7 more centers
Identifiers
NCT: NCT07365995 · BNT324-03 · 2025-524445-27-00