New study for men with high-risk prostate cancer with a known BRCA mutation.

Trial ID:
IRB-25-8611
Munveer S Bhangoo, MD

Inclusion Criteria

Patients must:

  • be male and at least 18 years old
  • have a histologically documented diagnosis of prostate adenocarcinoma.
  • be willing to provide a tumor tissue sample from surgery for BRCA mutation testing.
  • have confirmed BRCA1 or BRCA2 mutation testing by the central study lab.
  • have ECOG 0 or 1.
  • have a life expectancy of 5 years.
  • have a CT or MRI and a bone scan following the completion of their planned radiation therapy.
  • have a PSMA-PET scan following the completion of their planned radiation therapy (an 8-week interval is required from the time of completion of radiation therapy) to confirm
  • use a condom from the time they sign the study consent form and until 6 months after the last dose of the study drug. Any female partners who are women of childbearing potential should use a highly effective method of contraception for the same period.
  • have adequate organ and bone marrow function.

Exclusion Criteria

Patients must not:

  • have a history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
  • have radiation-associated side effects.
  • have any known predisposition to bleeding.
  • have any history of persistent severe cytopenia due to any cause.
  • have unmanageable nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated study medication product, or previous significant bowel resection that would preclude adequate absorption.
  • have a history of another primary malignancy.
  • have any persistent toxicities caused by previous anticancer treatment.
  • have an abnormal ECG cardiology test.
  • have a history of cardiac arrhythmia, atrial fibrillation, or ventricular tachycardia.
  • have active and uncontrolled hepatitis B and/ or hepatitis C.
  • have active and uncontrolled HIV infection.
  • have active tuberculosis infection.
  • have had any major surgical procedures or significant traumatic injury within 4 weeks of the first dose of study intervention.

Additional Info

All treatment and physician visits will take place at the Scripps Clinic Torrey Pines Geisel Pavilion.

All participants must have received a planned regimen of ADT and must remain on their pre-treatment ADT regimen throughout the study.

Grapefruit juice and St. John's Wort should also be avoided.

For more information, search the web for NCT06952803.

Contact Info:

  • Clinical Research Services
  • CRSleadership@scrippshealth.org