This study is for subjects that have been diagnosed with prostate cancer. Subjects can expect to remain in the study for up to 39 months or longer. There will be a total of 16 enrolled locally. The study is set to enroll subjects for 39 months.
This study is for patients who have been diagnosed with prostate cancer that is prostate-specific membrane antigen (PSMA)-positive and has spread despite treatment with another androgen receptor pathway inhibitor (ARPI). This study is testing an investigational drug called AAA817. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). In this study, participants will be randomly assigned (like flipping a coin) to receive AAA817 alone, AAA817 with an androgen receptor pathway inhibitor (ARPI), or standard of care treatment. The primary purpose of this study is to determine whether AAA817, given alone or in combination with an ARPI, is safe and effective compared to standard of care treatments. This drug is given to participants as a radioligand therapy infusion. Participants in this study can expect to be in the study for up to 6.1 years, including two visits before starting treatment, visits every 4 weeks during treatment, and visits every 12 weeks during long-term follow-up for up to 5 years after treatment ends.. There will be a total of 9 patients enrolled locally.
This study is for patients who have been diagnosed with metastatic hormone-sensitive prostate cancer (mHSPC).This study is testing an investigational drug called Tulmimetostat, which will be given in combination with standard prostate cancer treatments: Darolutamide or Abiraterone. "Investigational" means that Tulmimetostat has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to determine the safety and potential benefits of Tulmimetostat when given with Darolutamide or Abiraterone. The study will also evaluate whether adding Tulmimetostat can delay the progression of prostate cancer compared to treatment with Darolutamide alone. Participants will receive the study drug by mouth, along with standard androgen deprivation therapy (ADT). Those receiving abiraterone will also take a low-dose corticosteroid (prednisone or prednisolone) to help prevent side effects. Participants can expect to be in the study as long as they are benefiting from treatment or until the study ends. During the first 4 weeks, study visits will occur on Days 1, 2, 8, 15, and 22. Beginning with Cycle 2, participants will have visits on Day 1 of every 4-week cycle. At study visits, participants will undergo health assessments such as physical exams, blood and urine tests, heart monitoring (ECG), imaging scans (CT or MRI), and health questionnaires. Some participants may also have an optional biopsy. A total of 8 patients will be enrolled locally over the course of 32 months.