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

Cabazitaxel administered as a single intravenous dose every 3 weeks, in combination with abiraterone acetate and prednisone taken daily.

Cabazitaxel administered as a single intravenous dose every 3 weeks

Cabazitaxel intravenously every 3 weeks, in combination with abiraterone acetate and prednisone orally daily.

Cabazitaxel with Abiraterone Acetate

Cabazitaxel

Elaine Lam, MD

Patients are being asked to take place in this research study because they have advanced prostate cancer that has gotten worse after other treatments. If they join this study they will receive a new combination of drugs that are used to treat prostate cancer.

Abiraterone acetate and cabazitaxel have been approved by the United States Food and Drug Administration (FDA) to treat prostate cancer that has spread to other parts of the body such as the lymph nodes or bone. These drugs are approved individually for use when the cancer has become resistant to other treatments, including chemotherapy with docetaxel. The combination of these two drugs has not been evaluated, so the research team will study the safety and effectiveness of the combination.

Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Prostate Cancer

Phase II Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel, Compared to Cabazitaxel Alone, in Patients With Metastatic Castrate Resistant Prostate Cancer.

Prostate specific antigen (PSA) decline by 50% or more from baseline.

Janssen Services, LLC

University of Colorado, Denver

Due to early closure and small number of patients enrolled, no statistics or firm conclusions can be made. The 5 patients treated in the combination arm were treated with the standard dosing of both abiraterone acetate and cabazitaxel.

Cabazitaxel administered as a single intravenous dose every 3 weeks, in combination with abiraterone acetate and prednisone taken daily.

Cabazitaxel with Abiraterone Acetate: Cabazitaxel intravenously every 3 weeks, in combination with abiraterone acetate and prednisone orally daily.

Cabazitaxel With Abiraterone Acetate

Cabazitaxel administered as a single intravenous dose every 3 weeks

Cabazitaxel: Cabazitaxel intravenously every 3 weeks

Cabazitaxel Alone

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Prior Docetaxel AND Abiraterone

Due to early closure of the study and the low number of patients enrolled, no statistics or firm conclusions can be made.

Spots Global Cancer Trial Database for cabazitaxel with abiraterone acetate