Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer

Launched by MAMTA PARIKH · Dec 7, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring how well two different treatments work for men with advanced prostate cancer, which is cancer that has spread from its original site to other parts of the body. The trial compares the effects of a combination of abiraterone and prednisone, versus darolutamide on its own. Abiraterone helps reduce male hormones that can encourage cancer growth, while darolutamide blocks those hormones from being used by the cancer cells. Prednisone is included to help reduce inflammation and the body's immune response. Researchers want to find out both the benefits and possible side effects of these treatments.

To be eligible for this trial, participants must be adult men (18 years or older) with confirmed advanced prostate cancer who can understand and agree to the study. They are encouraged to be currently receiving hormone therapy or have had surgery to remove their testicles. Participants should also have a good performance status, meaning they can carry out daily activities with minimal assistance. Those who have been treated with abiraterone or darolutamide in the past month are not eligible. If you decide to join, you can expect to follow a structured schedule for visits and tests throughout the study.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Ability to understand and willingness to sign an informed consent form
• • Histologically confirmed prostate adenocarcinoma
• • Advanced prostate cancer appropriate for treatment with abiraterone acetate plus prednisone or darolutamide as assessed by the treating physician
• • Participants are encouraged to be currently treated with androgen deprivation therapy (ADT) or having undergone bilateral orchiectomy
• • Performance status 0 - 2 (Karnofsky ≥ 50%)
• • Age ≥ 18 years at time of consent
• • Life expectancy ≥ 6 months per investigator discretion
• • Ability and stated willingness to adhere to the study visit schedule and other protocol procedures/requirements for the duration of the study
• Exclusion Criteria:
• • Have been on either abiraterone or darolutamide for \> 28 days prior to initiating enrollment
• • Any condition that in the opinion of the investigator would prohibit the understanding or rendering of informed consent or interfere with the participant's safety or compliance while on trial