Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer

• Status: Active, not recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montefiore Medical Center
• Treatments: Abiraterone Acetate; Hormones; Prednisone

Criteria

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

1. Total testosterone level of <50 ng/dl

2. Total bilirubin < 2.0 X Upper Limit of Normal (ULN)

3. Aspartate aminotransferase (AST) ≤ 3 X ULN

4. Alanine aminotransferase (ALT ) ≤ 3 X ULN

5. Absolute Neutrophil Count > 1.5 K/mm3

6. Platelets > 100 K/mm3

7. Hemoglobin ≥9.0 g/dL

8. calculated creatinine clearance ≥ 30 mL/min

Exclusion Criteria:

10. History of bilateral orchiectomy

11. History of hypopituitarism

12. For patient not yet started on abiraterone with prednisone, uncontrolled hypertension (systolic blood pressure >170 mm Hg or diastolic blood pressure >100 mm Hg)

13. 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

14. Any other serious illness or medical condition that the principal investigator feels would make the patient a poor candidate for this study