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
Actual
Conditions
Prostatic Neoplasms
Eligibility Criteria
Inclusion Criteria:
* The patient must be able to provide study-specific informed consent prior to study entry
* Age ≥ 18
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
* Pathologically proven diagnosis of prostate adenocarcinoma
* Patients must have metastatic prostate cancer
* Patients may have mCRPC or may have metastatic castration-sensitive disease.
* Patients must be maintained on a GnRH analogue (agonist (leuprolide, goserelin, triptorelin, histrelin, deslorelin) or antagonist (degarelix))
* 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.
* Lab values meeting the following criteria
* Total testosterone level of \<50 ng/dl
* Total bilirubin \< 2.0 X Upper Limit of Normal (ULN)
* Aspartate aminotransferase (AST) ≤ 3 X ULN
* Alanine aminotransferase (ALT) ≤ 3 X ULN
* Absolute Neutrophil Count \> 1.5 K/mm3
* Platelets \> 100 K/mm3
* Hemoglobin ≥ 9.0 g/dL
* Calculated creatinine clearance ≥ 30 mL/min
Exclusion Criteria:
* History of bilateral orchiectomy
* History of hypopituitarism
* For patients not yet started on abiraterone with prednisone, uncontrolled hypertension (systolic blood pressure \>170 mm Hg or diastolic blood pressure \>100 mm Hg)
* 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
* Any other serious illness or medical condition that the principal investigator feels would make the patient a poor candidate for this study
* The patient must be able to provide study-specific informed consent prior to study entry
* Age ≥ 18
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
* Pathologically proven diagnosis of prostate adenocarcinoma
* Patients must have metastatic prostate cancer
* Patients may have mCRPC or may have metastatic castration-sensitive disease.
* Patients must be maintained on a GnRH analogue (agonist (leuprolide, goserelin, triptorelin, histrelin, deslorelin) or antagonist (degarelix))
* 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.
* Lab values meeting the following criteria
* Total testosterone level of \<50 ng/dl
* Total bilirubin \< 2.0 X Upper Limit of Normal (ULN)
* Aspartate aminotransferase (AST) ≤ 3 X ULN
* Alanine aminotransferase (ALT) ≤ 3 X ULN
* Absolute Neutrophil Count \> 1.5 K/mm3
* Platelets \> 100 K/mm3
* Hemoglobin ≥ 9.0 g/dL
* Calculated creatinine clearance ≥ 30 mL/min
Exclusion Criteria:
* History of bilateral orchiectomy
* History of hypopituitarism
* For patients not yet started on abiraterone with prednisone, uncontrolled hypertension (systolic blood pressure \>170 mm Hg or diastolic blood pressure \>100 mm Hg)
* 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
* 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:
* The patient must be able to provide study-specific informed consent prior to study entry
* Age ≥ 18
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
* Pathologically proven diagnosis of prostate adenocarcinoma
* Patients must have metastatic prostate cancer
* Patients may have mCRPC or may have metastatic castration-sensitive disease.
* Patients must be maintained on a GnRH analogue (agonist (leuprolide, goserelin, triptorelin, histrelin, deslorelin) or antagonist (degarelix))
* 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.
* Lab values meeting the following criteria
* Total testosterone level of \<50 ng/dl
* Total bilirubin \< 2.0 X Upper Limit of Normal (ULN)
* Aspartate aminotransferase (AST) ≤ 3 X ULN
* Alanine aminotransferase (ALT) ≤ 3 X ULN
* Absolute Neutrophil Count \> 1.5 K/mm3
* Platelets \> 100 K/mm3
* Hemoglobin ≥ 9.0 g/dL
* Calculated creatinine clearance ≥ 30 mL/min
* The patient must be able to provide study-specific informed consent prior to study entry
* Age ≥ 18
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
* Pathologically proven diagnosis of prostate adenocarcinoma
* Patients must have metastatic prostate cancer
* Patients may have mCRPC or may have metastatic castration-sensitive disease.
* Patients must be maintained on a GnRH analogue (agonist (leuprolide, goserelin, triptorelin, histrelin, deslorelin) or antagonist (degarelix))
* 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.
* Lab values meeting the following criteria
* Total testosterone level of \<50 ng/dl
* Total bilirubin \< 2.0 X Upper Limit of Normal (ULN)
* Aspartate aminotransferase (AST) ≤ 3 X ULN
* Alanine aminotransferase (ALT) ≤ 3 X ULN
* Absolute Neutrophil Count \> 1.5 K/mm3
* Platelets \> 100 K/mm3
* Hemoglobin ≥ 9.0 g/dL
* 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
Completed
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
The number/percentage of patients with a castrate serum testosterone level, defined as having a serum castrate concentration \<50 ng/dL when Abiraterone acetate plus prednisone (AAP) is used without GnRH analogues in metastatic prostate cancer, will be determined. Results are summarized as a number/percentage of participants.
Outcome Measure
Percentage of Patients With Castrate Level of Serum Testosterone
Outcome Time Frame
Approximately 24 weeks
Secondary Outcomes
Outcome Description
Mean serum testosterone (T) concentrations in patients with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue was measured. Results have been summarized and reported in nanograms/deciliter (ng/dL) using basic descriptive statistics.
Outcome Time Frame
Baseline and 6 months, 12 months, 18 months, 24 months, and 30 months following initiation of treatment
Outcome Measure
Serum Testosterone (T) Levels
Outcome Description
Mean serum LH levels in patients with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue was measured. Results have been summarized and reported in International Units/Liter (IU/L) using basic descriptive statistics.
Outcome Time Frame
Baseline and 6 months, 12 months, 18 months, 24 months, and 30 months following initiation of treatment
Outcome Measure
Serum Luteinizing Hormone (LH) Levels
Outcome Description
Mean PSA response in patients with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue was measured. Results have been summarized and reported in ng/mL using basic descriptive statistics.
Outcome Time Frame
Baseline and 6 months, 12 months, 18 months, 24 months, and 30 months following initiation of treatment
Outcome Measure
Prostate-specific Antigen (PSA) Response
Outcome Description
The number of patients with treatment-related adverse events due to toxicity which lead to discontinuation from the study at 24 weeks is summarized.
Outcome Time Frame
24 weeks
Outcome Measure
Treatment-related Adverse Events Due to Toxicity
Outcome Description
The duration of time from trial entry until radiographic progression-free survival will be measured/reported. Progression-free survival is an assessment of the average time a patient lives without disease progression, as detected on radiographic imaging scans, or the patient dies from the disease, whichever comes first. Results have been summarized and reported in weeks using basic descriptive statistics.
Outcome Time Frame
From initiation of treatment to the end of treatment, up to approximately 41 months (~178 weeks)
Outcome Measure
Radiographic Progression-free Survival (rPFS)
Outcome Description
Overall survival is an assessment of survival from the time initiation of treatment until the time of death to death due to any cause. Results have been summarized and reported in weeks using basic descriptive statistics.
Outcome Time Frame
From initiation of treatment until the end of treatment, up to approximately 41 months
Outcome Measure
Overall Survival (OS)
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
Categories Mesh Debug
Prostate Cancer --- PROSTATIC NEOPLASMS
Prostate Cancer --- GENITAL NEOPLASMS, MALE
Prostate Cancer --- UROGENITAL NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Prostate Cancer --- PROSTATIC DISEASES
MeSH Terms
PROSTATIC NEOPLASMS
GENITAL NEOPLASMS, MALE
UROGENITAL NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
GENITAL DISEASES, MALE
GENITAL DISEASES
UROGENITAL DISEASES
PROSTATIC DISEASES
MALE UROGENITAL DISEASES
ABIRATERONE ACETATE
PREDNISONE
ANDROSTENES
ANDROSTANES
STEROIDS
FUSED-RING COMPOUNDS
POLYCYCLIC COMPOUNDS
PREGNADIENEDIOLS
PREGNADIENES
PREGNANES