Purpose

The goal of this study is to find out if patients with prostate cancer being treated with the medications abiraterone and prednisone can discontinue hormone injections (examples include leuprolide, goserelin, triptorelin and degarelix). Abiraterone and prednisone are pills used to treat patients with prostate cancer. When abiraterone 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 if testosterone in the blood will stay low while abiraterone and prednisone are used without continued hormone injections.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. The patient must be able to provide study-specific informed consent prior to study entry
  2. Age ≥ 18
  3. ECOG Performance Status 0-2
  4. Pathologically proven diagnosis of prostate adenocarcinoma
  5. Patients must have metastatic prostate cancer
  6. Patients may have mCRPC or may have metastatic castration-sensitive disease.
  7. Patients must be maintained on a GnRH analogue (agonist (leuprolide, goserelin, triptorelin, histerelin, deslorin) or antagonist (degarelix))
  8. 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.
  9. Lab values meeting the following criteria
  10. Total testosterone level of <50 ng/dl
  11. Total bilirubin < 2.0 X Upper Limit of Normal (ULN)
  12. Aspartate aminotransferase (AST) ≤ 3 X ULN
  13. Alanine aminotransferase (ALT ) ≤ 3 X ULN
  14. Absolute Neutrophil Count > 1.5 K/mm3
  15. Platelets > 100 K/mm3
  16. Hemoglobin ≥9.0 g/dL
  17. calculated creatinine clearance ≥ 30 mL/min

Exclusion Criteria

  1. History of bilateral orchiectomy
  2. History of hypopituitarism
  3. For patient not yet started on abiraterone with prednisone, uncontrolled hypertension (systolic blood pressure >170 mm Hg or diastolic blood pressure >100 mm Hg)
  4. 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
  5. Any other serious illness or medical condition that the principal investigator feels would make the patient a poor candidate for this study

Study Design

Phase
Phase 2
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Abiraterone and Prednisone without a GnRH Analogue
Abiraterone (1000 mg daily) with Prednisone (5 mg) with Discontinuation of GnRH Analogue Injection
  • Drug: Abiraterone Acetate
    Abiraterone Acectate with Prednisone and with Discontinue of GnRH Analogue
  • Drug: Prednisone
    Abiraterone Acectate with Prednisone and with Discontinue of GnRH Analogue

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10461
Contact:
Benjamin Gartrell, MD
718-405-8404
bgartrel@montefiore.org

More Details

NCT ID
NCT03565835
Status
Recruiting
Sponsor
Montefiore Medical Center

Study Contact

Benjamin Gartrell, MD
718-405-8404
bgartrel@montefiore.org

Detailed Description

Abiraterone inhibits the CYP17A enzyme, which is a critical enzyme in androgen biosynthesis. Abiraterone has regulatory approval in metastatic castration-resistant prostate cancer (mCRPC) in both chemotherapy-naïve and in the post-docetaxel setting based upon results from two randomized phase III studies. Abiraterone is also proven to extend survival in the metastatic, hormone-naïve population based on two phase III studies. Abiraterone is a castrating agent, but, other than a small first in human study, all clinical studies have been done in conjunction with gonadotropin-releasing hormone (GnRH) analogues. Maintaining castrate level of serum testosterone is critical in the treatment of metastatic prostate cancer. It is unknown if GnRH analogues must be continued to maintain castrate levels of serum testosterone in patients treated with abiraterone.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.