ProstACT Global

NCT06520345

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Learn about this study

A Phase 3 study of 177Lu rosopatamab tetraxetan (TLX591) plus standard of care (SoC) versus SoC alone in patients with metastatic castration-resistant prostate cancer (mCRPC) . This is when the cancer continues to grow and spread even when testosterone levels are very low. 

This global Phase 3 study is designed to investigate and confirm the benefits and risks associated with TLX591 administered together with standard of care (SoC), as compared to the best SoC alone. The study is being conducted in patients with metastatic castration-resistant prostate cancer (mCRPC) that expresses PSMA, and has progressed despite prior treatment with hormone therapy.

Who can participate?

Participating in clinical research is a significant, personal decision. Before enrolling, the study team will fully explain the research, and provide an Informed Consent Form that outlines possible benefits and risks. This is your chance to ask questions and consult with your doctor to determine if the study is right for you.

You may be able to participate if you have:

  • Documented tumor of the prostate defined by biopsy
  • A Progression on an Androgen Receptor Pathway Inhibitor (ARPI). Must have received a minimum of 12 weeks of prior therapy on your first ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide), received in either the Metastatic Castration-Sensitive Prostate Cancer (mCSPC), Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC) or Metastatic Castration-Resistant Prostate Cancer (mCRPC) setting, with evidence of disease progression while receiving this ARPI. 
  • Disease which has spread beyond the prostate
  • Castration-resistant prostate cancer 
  • PSMA-positive disease, as demonstrated by a PSMA-PET scan

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

Find a Site

Select your country and enter your location or use the map to find the closest clinical trial site(s) to you. Once you have found a site, use the site contact details to speak with their team to learn more about the trial eligibility. 

Clinical Trials FAQs

  • Clinical trials are essential for validating new treatments and are designed to determine if treatments are safe and effective in people. These studies have formed the foundation for many modern medical advances, including in cancer imaging and therapy.

  • Clinical trials are conducted by physicians following strict protocols. Each study requires approval from review boards and regulatory agencies before beginning. Trials continuously monitor the safety of participants and collect data, with research teams carefully documenting every aspect of the patient’s response to treatment.

  • Participation depends on each study’s specific requirements. Trials often seek patients with particular conditions, with eligibility based on factors like age, medical history, and current health status.

  • Clinical trials generally progress through four phases:

    • Phase 1 tests if the treatment is safe and well tolerated in a small group (usually less than 50 patients); 
    • Phase 2 examines the effectiveness of the treatment (usually less than 100 patients); 
    • Phase 3 compares the effectiveness of the treatment against current approved treatments (more than 100 patients) and is typically the study which generates the data for the product to be approved by the regulatory body to be used in all patients; and
    • Phase 4 is conducted after a drug is approved, these trials gather further safety information in broader patient populations.

  • Clinical trials follow strict safety protocols and Good Clinical Practice guidelines. Multiple oversight layers, including review boards and monitoring committees, ensure participant safety. While no medical research is without risk, trials incorporate extensive safety measures and regular health monitoring to ensure the safety of participants.

  • This provides a detailed list of Telix’s active studies for a range of cancers. If you are unable to find a trial that is right for you here, clinicaltrials.gov offers a larger ranger of trials.  Major medical centers also offer trial matching services, and your healthcare professional can help identify suitable opportunities. Patient advocacy groups and disease-specific organizations also maintain information about relevant trials.

  • After completion of a trial, research teams analyse the results to assess the treatments effect. In the case of a Phase 3 trial, the findings are submitted to the regulatory body, typically the U.S. Food and Drug Administration or FDA, to support the approval of the treatment. Participants receive result summaries and may continue beneficial treatments through extended access programs while awaiting final approval.

The information provided on this website is for general informational purposes only and may not reflect all current or upcoming clinical trials being conducted with Telix’s investigational assets. While we strive to keep the content up to date, inclusion of a trial on this site does not guarantee its availability, eligibility criteria, or status. For the most accurate and comprehensive information, please consult ClinicalTrials.gov.

If you are an individual interested in potentially enrolling in a clinical trial, please contact your health care provider for more information about what trials may be right for you.