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

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03565835
• Other study ID #: 2017-8506
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 13, 2018
• Est. completion date: January 17, 2023

Study information

• Verified date: September 2022
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: January 17, 2023
• Est. primary completion date: November 17, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The patient must be able to provide study-specific informed consent prior to study entry

2. Age = 18

3. ECOG (Eastern Cooperative Oncology Group) 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, histrelin, deslorelin) 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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• Abiraterone Acetate
Abiraterone Acetate with Prednisone and with Discontinuation of GnRH Analogue
• Prednisone
Abiraterone Acetate with Prednisone and with Discontinuation of GnRH Analogue

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with a non-castrate (>50 ng/dl) serum testosterone	To assess the proportion of patients with a non-castrate testosterone level (>50 ng/dl) when abiraterone acetate plus prednisone is used without GnRH analogues in metastatic prostate cancer.	24 weeks
Secondary	Luteinizing hormone (LH) level after discontinuation of GnRH analogue	To measure serum LH level in patients with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue.	24 weeks
Secondary	PSA (Prostate-specific antigen) response rate	To measure PSA response rate and in patient with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue.	24 weeks
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.03	To measure the incidence of adverse events	24 weeks
Secondary	Radiographic progression-free survival (rPFS)	To measure the time for trial entry until radiographic progression	24 weeks
Secondary	Median overall survival	To measure the median time from trial entry until death	24 weeks