Abiraterone

Generic Name
Abiraterone
Brand Names
Yonsa, Zytiga, Abiraterone Krka, Abiraterone Accord, Abiraterone Mylan
Drug Type
Small Molecule
Chemical Formula
C24H31NO
CAS Number
154229-19-3
Unique Ingredient Identifier
G819A456D0
Background

Abiraterone is a potent, irreversible, and selective inhibitor of 17 αhydroxylase/C17,20-lyase (CYP17), an enzyme expressed in testicular, adrenal, and prostatic tumour tissues, to regulate androgen biosynthesis. Abiraterone was first approved by the FDA and EMA on April, July, and September 2011, respectively. It is used to treat metastatic castration-resistant prostate cancer and hormone-sensitive high-risk metastatic prostate cancer.

As abiraterone has poor oral bioavailability and is susceptible to hydrolysis by esterases, abiraterone acetate was developed as an orally bioavailable prodrug with enhanced stability and absorption.

Indication

Abiraterone is indicated for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in combination with methylprednisolone or prednisone.

In Europe and Canada, it is also used in patients with mCRPC who are asymptomatic or mildly symptomatic after the failure of androgen deprivation therapy for whom chemotherapy is not yet clinically indicated. In Europe, it is used in patients whose disease has progressed on or after a docetaxel-based chemotherapy regimen. In Canada, it is used in patients who have received prior chemotherapy containing docetaxel after the failure of androgen deprivation therapy.

Abiraterone is indicated in combination with prednisone for the treatment of metastatic high-risk castration-sensitive prostate cancer (CSPC). In Europe and Canada, it may also be used in combination with prednisolone and androgen deprivation therapy in newly diagnosed patients.

In Canada and the US, abiraterone is also available in a combination product with niraparib, which is indicated with prednisone for the treatment of adults with deleterious or suspected deleterious BRCA-mutated (BRCAm) mCRPC. In Canada, this combination product is also used with prednisolone and is reserved for patients who are asymptomatic or mildly symptomatic, and in whom chemotherapy is not clinically indicated.

Associated Conditions
Metastatic Castration Sensitive Prostate Cancer (mCSPC), Metastatic Castration-Resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Associated Therapies
-

Dose-Finding Study of Afuresertib Administered in Combination With Either Enzalutamide or Aibraterone

First Posted Date
2015-03-05
Last Posted Date
2016-10-06
Lead Sponsor
GlaxoSmithKline
Registration Number
NCT02380313

Cabazitaxel Versus the Switch to Alternative AR Targeted Therapy Enzalutamide or Abiraterone in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Primary Resistant Patients to Abiraterone or Enzalutamide

First Posted Date
2015-03-04
Last Posted Date
2019-06-21
Lead Sponsor
Sanofi
Target Recruit Count
8
Registration Number
NCT02379390
Locations
🇨🇦

Investigational Site Number 124005, Hamilton, Canada

🇨🇦

Investigational Site Number 124002, Montreal, Canada

🇨🇦

Investigational Site Number 124009, Quebec, Canada

and more 21 locations

Micro RNAs to Predict Response to Androgen Deprivation Therapy

First Posted Date
2015-02-19
Last Posted Date
2024-11-25
Lead Sponsor
Medical College of Wisconsin
Target Recruit Count
42
Registration Number
NCT02366494
Locations
🇺🇸

Froedtert Hospital, Milwaukee, Wisconsin, United States

Men With Metastatic Castrate-Resistant Prostate Cancer Treated With Either Sipuleucel-T (Provenge®), Abiraterone Acetate (Zytiga®) or Enzalutamide (Xtandi®) Undergoing Cardiopulmonary EXercise Testing

First Posted Date
2015-02-03
Last Posted Date
2020-12-24
Lead Sponsor
Duke University
Target Recruit Count
38
Registration Number
NCT02353715
Locations
🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

Enzalutamide/Leuprolide +/- Abiraterone/Pred in Prostate

First Posted Date
2014-10-20
Last Posted Date
2022-04-19
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
75
Registration Number
NCT02268175
Locations
🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

and more 1 locations

Cabazitaxel vs Abiraterone or Enzalutamide in Patients With Poor Prognosis Metastatic Castration-resistant Prostate Cancer

First Posted Date
2014-10-02
Last Posted Date
2017-12-06
Lead Sponsor
British Columbia Cancer Agency
Target Recruit Count
120
Registration Number
NCT02254785
Locations
🇨🇦

BCCA - Kelowna, Kelowna, British Columbia, Canada

🇦🇺

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

🇨🇦

Durham Regional Cancer Centre (Lakeridge Health), Oshawa, Ontario, Canada

and more 12 locations

A Phase II Neoadjuvant Study of Enzalutamide, Abiraterone Acetate, Dutasteride and Degarelix in Men With Localized Prostate Cancer Pre-prostatectomy

First Posted Date
2014-06-10
Last Posted Date
2015-01-26
Lead Sponsor
Kenneth Pienta, MD
Registration Number
NCT02159690
Locations
🇺🇸

Johns Hopkins Hospital, Baltimore, Maryland, United States

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