177Lu-TLX591 for Advanced Prostate Cancer
Trial Summary
What is the purpose of this trial?
The purpose of this study is to evaluate the efficacy and safety of 177Lu-TLX591 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with Androgen Receptor Pathway Inhibitor Treatment
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that you should not have received certain treatments like chemotherapy or other investigational therapies within 4 weeks of enrollment. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment 177Lu-TLX591 for advanced prostate cancer?
Is 177Lu-TLX591 safe for use in humans?
What makes the drug 177Lu-TLX591 unique for treating advanced prostate cancer?
177Lu-TLX591 is a novel radioligand therapy that targets prostate-specific membrane antigen (PSMA) on prostate cancer cells, similar to other treatments like 177Lu-PSMA-617, but it uses a different monoclonal antibody (rosopatamab) to deliver the radioactive lutetium-177, potentially offering a unique approach to targeting and treating advanced prostate cancer.24101112
Eligibility Criteria
This trial is for men over 18 with advanced prostate cancer that's resistant to hormone therapy and has spread despite treatment. They should have had prior therapy with specific drugs, be in relatively good health (ECOG status 0-2), and have a life expectancy of at least 6 months. Men who've received certain treatments like docetaxel must meet additional time criteria since their last dose.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Safety and Dosimetry Lead-in
Initial phase to assess safety and dosimetry in 30 patients
Randomized Treatment Expansion
Participants are randomized to receive either 177Lu-TLX591 with SOC or SOC alone
Long-term Follow-up
All patients will be followed for at least 5 years from the first therapeutic dose, death, or loss to follow-up
Treatment Details
Interventions
- 177Lu-TLX591
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Who Is Running the Clinical Trial?
Telix Pharmaceuticals (Innovations) Pty Ltd
Lead Sponsor
Telix Pharmaceuticals (Innovations) Pty Limited
Lead Sponsor