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Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy

Comparing AAA817 to standard care for advanced prostate cancer treatment.

Recruiting
18 years and older
Male
Phase 2/3

This study is researching a new treatment called **AAA817** for adults with a specific type of prostate cancer, called PSMA-positive mCRPC (metastatic castration-resistant prostate cancer). This cancer type continues to grow even after treatments that lower testosterone and chemotherapy. The study compares AAA817 to the usual treatments doctors use, known as the Standard of Care (SoC). This study has two parts: Phase II gathers information about the dose, and Phase III tests how well the treatment works and its safety.

  • Participants must have tried certain treatments before and have cancer that grew after a specific therapy called [177Lu]Lu-PSMA.
  • The study will include several visits, and treatments will be based on either AAA817 or SoC.
  • Participants should be aware of possible risks and side effects of new treatments.

Eligibility includes being 18 or older, having a good performance status, and confirmed prostate cancer with specific imaging results. Some conditions may exclude participation, such as other serious health issues or recent experimental treatments. Always consult with your doctor to understand if joining this study is right for you.

Study details
    Prostate Cancer

NCT06780670

Novartis Pharmaceuticals

17 October 2026

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