Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Abiraterone Acetate

Prednisone

Enzyme Inhibitors

Hormones

Hormone Antagonists

Cytochrome P-450 Enzyme Inhibitors

Abiraterone acetate 1000mg orally daily until the time of disease progression, in the absence of prohibitive toxicities.

Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily

Matthew Galsky, MD

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.

Abiraterone Acetate Trial in African American Prostate Cancer Patients

A Pilot Study of Abiraterone Acetate in African American/Black Patients With Castration Resistant Prostate Cancer

The primary objective of this study is to determine a correlation between inherited genetic polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in AA patients with castration-resistant prostate cancer treated with Abiraterone. The primary endpoint is the percent change in PSA from baseline to 12 weeks. A decline of ≥ 30% will be correlated with germline SNPs.

Post-treatment changes in measurable disease by RECIST - Response Evaluation Criteria in Solid Tumors Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

post-treatment changes in measurable disease by time to disease progression (as per PCWG2 guidelines)

post-treatment changes in bone scans (as per PCWG2 guidelines) ("no new lesions" versus "new lesions.")

To determine the safety of abiraterone Adverse events as defined by CTCAE v4. Number of participants with serious adverse events grade 4 or 5

Icahn School of Medicine at Mount Sinai

Associate Professor

Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily

Age, Continuous

Sex: Female, Male

Number of prior systemic therapies

ECOG (Eastern Cooperative Oncology Group) Performance Status:

0= Fully active; 1=restricted in physically strenuous activity but ambulatory, light work; 2= ambulatory and capable of self care, but no any work activities; 3= capable of only limited self care; 4 = completely disabled, 5= dead

Performance Status: ECOG

Dr. Matthew David Galsky

Number of Participants With ≥ 30% Change in PSA

Response Assessment

Time to Progression

Bone Scan

Safety of Abiraterone

Testosterone

Abiraterone acetate 1000mg orally daily until the time of disease progression, in the absence of prohibitive toxicities.

Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily

Spots Global Cancer Trial Database for Abiraterone Acetate Trial in African American Prostate Cancer Patients

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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