Brief 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.
Brief Title
Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Prostatic Neoplasms
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 (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
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
Inclusion Criteria
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
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
Gender
Male
Gender Based
false
Keywords
abiraterone
prostate cancer
androgen deprivation therapy
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03565835
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2017-8506
Overall Status
Unknown status
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer
Primary Outcomes
Outcome 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.
Outcome Measure
Proportion of patients with a non-castrate (>50 ng/dl) serum testosterone
Outcome Time Frame
24 weeks
Secondary Outcomes
Outcome Description
To measure serum LH level in patients with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue.
Outcome Time Frame
24 weeks
Outcome Measure
Luteinizing hormone (LH) level after discontinuation of GnRH analogue
Outcome Description
To measure PSA response rate and in patient with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue.
Outcome Time Frame
24 weeks
Outcome Measure
PSA (Prostate-specific antigen) response rate
Outcome Description
To measure the incidence of adverse events
Outcome Time Frame
24 weeks
Outcome Measure
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Outcome Description
To measure the time for trial entry until radiographic progression
Outcome Time Frame
24 weeks
Outcome Measure
Radiographic progression-free survival (rPFS)
Outcome Description
To measure the median time from trial entry until death
Outcome Time Frame
24 weeks
Outcome Measure
Median overall survival
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Benjamin Gartrell
Investigator Email
bgartrel@montefiore.org
Investigator Phone
718-405-8404