Description:
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.
Title
- Brief Title: Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer
- Official Title: Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer
Clinical Trial IDs
- ORG STUDY ID:
2017-8506
- NCT ID:
NCT03565835
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Abiraterone Acetate | | Abiraterone and Prednisone without a GnRH Analogue |
Prednisone | | Abiraterone and Prednisone without a GnRH Analogue |
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.
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Abiraterone and Prednisone without a GnRH Analogue | Experimental | Abiraterone (1000 mg daily) with Prednisone (5 mg) with Discontinuation of GnRH Analogue Injection | - Abiraterone Acetate
- Prednisone
|
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Proportion of patients with a non-castrate (>50 ng/dl) serum testosterone |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | 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. |
Secondary Outcome Measures
Measure: | Luteinizing hormone (LH) level after discontinuation of GnRH analogue |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | To measure serum LH level in patients with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue. |
Measure: | PSA response rate |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | To measure PSA response rate and in patient with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue. |
Measure: | Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | To measure the incidence of adverse events |
Measure: | Radiographic progression-free survival (rPFS) |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | To measure the time for trial entry until radiographic progression |
Measure: | Median overall survival |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | To measure the median time from trial entry until death |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Montefiore Medical Center |
Trial Keywords
- abiraterone
- prostate cancer
- androgen deprivation therapy
Last Updated
February 21, 2021