Phase 3 study of MK-5684 versus alternative NHA in mCRPC post one NHA

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment with One Next-generation Hormonal Agent (NHA)

• IRAS ID

  1008712

• Contact name

  - -

• Contact email

  -

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Research summary

  Researchers are looking for new ways to treat participants with a type of prostate cancer called metastatic castration-resistant prostate cancer (mCRPC). In mCRPC, the cancer has spread to other parts of the body, got worse or came back after standard hormone therapy. Standard hormone therapy is treatment to lower the level of certain hormones in the body to slow the growth and spread of cancer cells. Recent types of hormone therapy used to treat mCRPC are called next-generation hormonal agents (NHA). MK-5684 is a study medicine designed to treat mCRPC by blocking the body from making steroid hormones. Researchers will give MK-5684 with hormone replacement therapy (HRT) because the body needs steroid hormones to control body functions such as balancing water and blood pressure.
  Researchers want to learn if participants who take MK-5684 live longer overall and without the cancer getting worse compared to participants who take NHA. About 1,500 participants with mCRPC will be in this study. They will be at least 18 years old and:
  • Have a type of prostate cancer that got worse during or after treatment with no more than 1 NHA
  • Have not received certain chemotherapy to treat mCRPC.
  Participants will take one of these treatments by mouth as tablets:
  • MK-5684 with HRT (dexamethasone and fludrocortisone)
  • NHA, either:
  o Abiraterone acetate and prednisone
  o Enzalutamide
  Participants may take MK-5684 or prednisone twice a day. All other treatments will be taken once a day. Participants will continue their treatment until the cancer gets worse or the person doesn’t tolerate treatment. Participants and the researcher will know which study treatment a person is getting. During the study, participants will give urine and blood samples, have imaging tests and physical examinations, and answer questions about how they are feeling and their ability to carry out daily tasks.

• REC name

  Wales REC 1

• REC reference

  23/WA/0333

• Date of REC Opinion

  30 Jan 2024

• REC opinion

  Further Information Favourable Opinion