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RecruitingPhase 3

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

A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 28 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares BNT324 with docetaxel chemotherapy given with prednisone or prednisolone, which are steroid medicines. It is for adult men whose prostate cancer has spread and worsened despite treatment to lower or block male hormones, and who have not had chemotherapy for this stage of cancer. The study will test safety and whether BNT324 helps people live longer and keeps cancer from getting worse.

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 \[OS\]).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be a man age 18 or older, or meet the local legal age requirement.
  • Have prostate cancer that is getting worse, shown by rising PSA blood test results or scans of soft tissue or bones.
  • Have had 1 or 2 treatments that block male hormone signals, with cancer worsening during or after at least 8 weeks of treatment.
  • Have had no cell-killing chemotherapy, including taxane drugs, for prostate cancer that has spread and resists hormone-lowering treatment.
  • Have had surgery to remove the testicles and/or be on hormone-lowering treatment, with testosterone below 50 ng/dL. Continue hormone-lowering medicines during the study if taking them.
  • Be fully active or able to walk and do light work, even if unable to do hard physical activity.

Who can't join

  • Have had treatment aimed at B7-H3, a protein targeted by some cancer medicines.
  • Have uncontrolled or serious heart or blood vessel disease, as defined by the study.
  • Have current lung inflammation called ILD or pneumonitis, or a history of this condition not caused by infection that needed steroid treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key 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. Key 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.

Study sites (21)

CA

CO

FL

GA

IL

MD

NY

OH

SC

TN

TX

VA