Clinical trial NCT01735396: Abiraterone Acetate Trial in African American Prostate Cancer Patients
Official title: A Pilot Study of Abiraterone Acetate in African American/Black Patients With Castration Resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: African American men
metastatic prostate cancer
castration resistant
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2012-11-28
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study of abiraterone acetate in African American/Black patients with castration-resistant prostate cancer. The primary objective is to determine the correlation between germline polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in African American patients with castration-resistant prostate cancer treated with abiraterone acetate. Patients will receive abiraterone acetate until the time of disease progression, in the absence of prohibitive toxicities. Patients will be followed for disease progression and survival.


Eligibility criteria: Inclusion Criteria:

* 1. Have signed an informed consent document indicating that the subjects understands the purpose of and procedures required for the study and are willing to participate in the study
* Be willing/able to adhere to the prohibitions and restrictions specified in this protocol
* Written Authorization for Use and Release of Health and Research Study Information
* African American or Black (by self identification)
* Male aged 18 years and above
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Metastatic disease documented by standard imaging
* Progressive prostate cancer based on either rising PSA, new bone metastases, or progression of measurable disease according to PCWG2 12 guidelines.
* Patients in either of the following clinical states will be eligible for enrollment:

  i. No prior chemotherapy; ii. Patients previously treated with 1-2 prior chemotherapy regimens permitted, one of which must have been included docetaxel
* Surgically or medically castrated, with testosterone levels of \< 50 ng/dl.
* Patients previously treated with an anti-androgen must demonstrate progression off of the anti-androgen.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
* Have a baseline serum potassium of ≥ 3.5 mEq/L
* Have aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin levels \< 1.5 x ULN
* Have a serum albumin of ≥ 3.0 g/dL
* Total bilirubin ≤ 1.5 x ULN
* Have a platelet count of ≥ 100,000/μL
* Have an absolute neutrophil count of \> 1500 cell/mm3
* Have a calculated creatinine clearance ≥ 60 mL/min
* Have a hemoglobin of ≥ 9.0 g/dL
* Able to swallow the study drug as a whole tablet
* Willing to take abiraterone acetate on an empty stomach; no food should be consumed at least two hours before and for at least one hour after the dose of abiraterone acetate is taken
* Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator during the study and for 1 week after last dose of abiraterone acetate

Exclusion Criteria:

* Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
* Known brain metastasis
* Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg) Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
* Active or symptomatic viral hepatitis or chronic liver disease
* History of pituitary or adrenal dysfunction
* Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III-IV heart disease or cardiac ejection fraction measurement of \< 50% at baseline
* Administration of an investigational therapeutic within 30 days of screening
* Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
* Have poorly controlled diabetes
* Have a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents
* Have a pre-existing condition that warrants long-term corticosteroid use in excess of study dose
* Have known allergies, hypersensitivity, or intolerance to abiraterone acetate or prednisone or their excipients

Primary outcomes:
measure: Number of Participants With ≥ 30% Change in PSA
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Response Assessment
timeFrame: up to 12 weeks
measure: Time to Progression
timeFrame: up to 12 weeks
measure: Bone Scan
timeFrame: up to 12 weeks
measure: Safety of Abiraterone
timeFrame: up to 12 weeks
measure: Testosterone
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Queens Cancer Center, Queens Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Matthew Galsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsao CK, Sfakianos J, Liaw B, Gimpel-Tetra K, Kemeny M, Bulone L, Shahin M, Oh WK, Galsky MD. Phase II Trial of Abiraterone Acetate Plus Prednisone in Black Men With Metastatic Prostate Cancer. Oncologist. 2016 Dec;21(12):1414-e9. doi: 10.1634/theoncologist.2016-0026. Epub 2016 Oct 14.