Abiraterone and Prednisone without Hormone Therapy in Treating Patients with Metastatic Prostate Cancer

Status: Active

Description

This phase II trial studies how well abiraterone acetate and prednisone work without hormone therapy in treating patients with prostate cancer that has spread to other places in the body. Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Prednisone is used to lessen inflammation and lower the body's immune response. When abiraterone acetate and prednisone are used, hormone injections are usually continued to maintain a low testosterone level in the blood. This study is being done to find out whether giving abiraterone acetate and prednisone without hormone injections would maintain lower levels of testosterone in the blood in patients with prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • The patient must be able to provide study-specific informed consent prior to study entry
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Pathologically proven diagnosis of prostate adenocarcinoma
  • Patients must have metastatic disease
  • Patients may have metastatic castration-resistant prostate cancer (mCRPC) or may have metastatic castration-sensitive disease
  • Patients must be maintained on a GnRH analogue (agonist [leuprolide, goserelin, triptorelin, histerelin, deslorin] or antagonist [degarelix])
  • The patient and the investigator have decided that the next line of cancer therapy will be abiraterone plus prednisone and the initial dose of abiraterone will be 1000 mg daily. Or patients may already be on abiraterone with prednisone at a dose of 1000 mg daily along with a GnRH analogue
  • Total testosterone level of < 50 ng/dl
  • Total bilirubin < 2.0 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) =< 3 x ULN
  • Alanine aminotransferase (ALT) =< 3 x ULN
  • Absolute neutrophil count > 1.5 K/mm^3
  • Platelets > 100 K/mm^3
  • Hemoglobin >= 9.0 g/dL
  • Calculated creatinine clearance >=30 mL/min

Exclusion Criteria

  • History of bilateral orchiectomy
  • History of hypopituitarism
  • For patient not yet started on abiraterone with prednisone, uncontrolled hypertension (systolic blood pressure > 170 mm Hg or diastolic blood pressure > 100 mm Hg)
  • Patients must not have New York Heart Association class III or IV heart failure at the time of screening. Patients must not have any unstable angina, myocardial infarction, or serious uncontrolled cardiac arrhythmia within 6 months prior to registration
  • Any other serious illness or medical condition that the principal investigator feels would make the patient a poor candidate for this study

Locations & Contacts

New York

Bronx
Montefiore Medical Center-Weiler Hospital
Status: Active
Contact: Benjamin Adam Gartrell
Phone: 718-405-8505

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To assess the proportion of patients with a non-castrate testosterone level (> 50 ng/dl) when abiraterone acetate plus prednisone is used without gonadotrophin releasing hormone (GnRH) analogues in metastatic prostate cancer.

SECONDARY OBJECTIVES:

I. To measure serum luteinizing hormone (LH) level in patients with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue.

II. To measure prostate-specific antigen (PSA) response rate, radiographic progression-free survival (rPFS) and median overall survival in patient with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue.

III. To monitor the safety profile of abiraterone acetate plus prednisone without a GnRH analogue in metastatic prostate cancer.

OUTLINE:

Patients receive abiraterone acetate orally (PO) once daily (QD) and prednisone PO twice daily (BID). Treatment continues for 3-24 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 12 weeks (+/- 4 weeks) for determination of subsequent therapies and survival.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Montefiore Medical Center-Weiler Hospital

Principal Investigator
Benjamin Adam Gartrell

Trial IDs

Primary ID 2017-8506
Secondary IDs NCI-2019-00731
Clinicaltrials.gov ID NCT03565835