Study on Abiraterone with Stopping Hormone Injections in Metastatic Prostate Cancer

Sponsor: Montefiore Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03565835

Provider View

This clinical trial is exploring whether patients with metastatic prostate cancer can safely stop hormone injections while taking the medications abiraterone and prednisone, which are used to lower testosterone levels.

Patient Parameters

Program Overview

The aim of this study is to determine if men with metastatic prostate cancer can maintain low testosterone levels using only the medications abiraterone and prednisone, without the need for ongoing hormone injections. These injections are typically used alongside abiraterone and prednisone to keep testosterone levels low, which is important in treating prostate cancer.

Description

Abiraterone is a medication that blocks a specific enzyme involved in producing male hormones, which can help treat prostate cancer. It is approved for use in patients with metastatic prostate cancer that is resistant to standard hormone therapy, both before and after chemotherapy. Abiraterone has been shown to improve survival in patients with metastatic prostate cancer that has not been treated with hormones. However, it is usually given along with hormone injections to keep testosterone levels low. This study is investigating whether these injections are necessary when taking abiraterone and prednisone.

Eligibility Criteria

Inclusion Criteria

  • Must be able to give informed consent to participate in the study.
  • Age 18 or older.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Diagnosed with prostate adenocarcinoma.
  • Have metastatic prostate cancer.
  • Can have either castration-resistant or castration-sensitive metastatic prostate cancer.
  • Currently receiving hormone injections (GnRH analogues).
  • Plan to start or are already taking abiraterone and prednisone at a dose of 1000 mg daily, along with hormone injections.
  • Meet specific lab test criteria:
    • Total testosterone level below 50 ng/dl.
    • Total bilirubin less than 2 times the upper limit of normal.
    • AST and ALT levels less than or equal to 3 times the upper limit of normal.
    • Neutrophil count greater than 1.5 K/mm3.
    • Platelet count greater than 100 K/mm3.
    • Hemoglobin level of at least 9.0 g/dL.
    • Creatinine clearance of at least 30 mL/min.

Exclusion Criteria

  • Have had both testicles removed.
  • Have a history of pituitary gland problems.
  • Have uncontrolled high blood pressure if not yet started on abiraterone and prednisone.
  • Have severe heart failure or recent serious heart problems.
  • Have any other serious illness or condition that would make participation in the study unsafe.

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