Abiraterone Acetate Trial in African American Prostate Cancer Patients
Maneno muhimu
Kikemikali
Tarehe
| Imethibitishwa Mwisho: | 03/31/2017 |
| Iliyowasilishwa Kwanza: | 11/23/2012 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 11/26/2012 |
| Iliyotumwa Kwanza: | 11/27/2012 |
| Sasisho la Mwisho Liliwasilishwa: | 04/03/2017 |
| Sasisho la Mwisho Lilichapishwa: | 05/11/2017 |
| Tarehe ya matokeo ya kwanza yaliyowasilishwa: | 04/03/2017 |
| Tarehe ya matokeo ya kwanza ya QC yaliyowasilishwa: | 04/03/2017 |
| Tarehe ya matokeo ya kwanza kuchapishwa: | 05/11/2017 |
| Tarehe halisi ya kuanza kwa masomo: | 11/30/2012 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 02/29/2016 |
| Tarehe ya Kukamilisha Utafiti: | 02/29/2016 |
Hali au ugonjwa
Uingiliaji / matibabu
Drug: Abiraterone Acetate
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Experimental: Abiraterone Acetate Abiraterone acetate 1000mg orally daily until the time of disease progression, in the absence of prohibitive toxicities. | Drug: Abiraterone Acetate Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | Male |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | 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 |
Matokeo
Hatua za Matokeo ya Msingi
1. Number of Participants With ≥ 30% Change in PSA [baseline and 12 weeks]
Hatua za Matokeo ya Sekondari
1. Response Assessment [up to 12 weeks]
2. Time to Progression [up to 12 weeks]
3. Bone Scan [up to 12 weeks]
4. Safety of Abiraterone [up to 12 weeks]
5. Testosterone [up to 12 weeks]
