Study on Apalutamide and Carotuximab for Advanced Prostate Cancer Resistant to Hormone Therapy

Sponsor: Edwin Posadas, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05534646

Provider View

This clinical trial is testing a combination of two drugs, apalutamide and carotuximab, to see if they can help control prostate cancer that has spread and is no longer responding to hormone therapy. The study will first check the safety of the drug combination before moving to a larger phase to compare its effectiveness against apalutamide alone.

Patient Parameters

Program Overview

This study is exploring whether a combination of two drugs, apalutamide and carotuximab, can help manage prostate cancer that has spread and is resistant to hormone therapy. Initially, the study will focus on ensuring the safety of this drug combination in a small group of patients. If deemed safe, the study will expand to compare how well the combination works against apalutamide alone in controlling cancer progression. Researchers will also monitor any side effects, the overall response to the treatment, and how many patients benefit from adding carotuximab.

Eligibility Criteria

Inclusion Criteria

  • Have prostate cancer that no longer responds to hormone therapy, with rising PSA levels.
  • Have tried one or two hormone therapies before, but not apalutamide.
  • Cannot or choose not to receive taxane chemotherapy, as decided by your doctor.
  • Agree to use effective birth control during the study and for three months after the last dose of treatment.

Exclusion Criteria

  • Have a type of prostate cancer that does not produce PSA or shows cancer growth without a rise in PSA.
  • Have used apalutamide before.
  • Have another cancer that needs active treatment.
  • Have been treated with carotuximab or similar drugs targeting CD105.
  • Have active bleeding issues or medical conditions with a high risk of bleeding.
  • Have Osler-Weber-Rendu syndrome.

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