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
-

Onvansertib in Combination With Abiraterone and Prednisone in Adult Patients With Metastatic Castration-Resistant Prostate Cancer

First Posted Date
2018-01-29
Last Posted Date
2024-11-07
Lead Sponsor
Cardiff Oncology
Target Recruit Count
72
Registration Number
NCT03414034
Locations
🇺🇸

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

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

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

Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer

First Posted Date
2017-09-29
Last Posted Date
2024-08-02
Lead Sponsor
VA Office of Research and Development
Target Recruit Count
28
Registration Number
NCT03298087
Locations
🇺🇸

VA Long Beach Healthcare System, Long Beach, CA, Long Beach, California, United States

🇺🇸

VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles, California, United States

🇺🇸

Hunter Holmes McGuire VA Medical Center, Richmond, VA, Richmond, Virginia, United States

Optimal Sequencing of Treatment Options for Poor Risk mCRPC Previously Treated With Docetaxel

First Posted Date
2017-09-28
Last Posted Date
2022-04-15
Lead Sponsor
The Netherlands Cancer Institute
Target Recruit Count
100
Registration Number
NCT03295565
Locations
🇳🇱

Deventer Ziekenhuis, Deventer, Netherlands

🇳🇱

Academisch medisch centrum Maastricht, Maastricht, Netherlands

🇳🇱

Haga Ziekenhuis, The Hague, Netherlands

and more 16 locations

Efficacy of Rotations Between Abiraterone Acetate and Apalutamide in mCRPC Patients

First Posted Date
2017-06-02
Last Posted Date
2020-11-18
Lead Sponsor
University of Athens
Registration Number
NCT03173859

Dose Escalation and Dose Expansion Study of GSK525762 in Combination With Androgen Deprivation Therapy in Participants With Castrate-resistant Prostate Cancer

First Posted Date
2017-05-11
Last Posted Date
2022-08-10
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
73
Registration Number
NCT03150056
Locations
🇬🇧

GSK Investigational Site, Glasgow, United Kingdom

Activity of Abiraterone Acetate in the Management of Cushing's Syndrome in Patients With Adrenocortical Carcinoma

First Posted Date
2017-05-09
Last Posted Date
2017-05-10
Lead Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Target Recruit Count
10
Registration Number
NCT03145285
Locations
🇮🇹

U.O Oncologia Medica, Brescia, BS, Italy

Randomized Phase II Study of Salvage XRT + ADT +/- Abiraterone and Apalutamide for Rising PSA After RP (FORMULA-509)

First Posted Date
2017-05-05
Last Posted Date
2024-05-14
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
345
Registration Number
NCT03141671
Locations
🇺🇸

University of Chicago, Chicago, Illinois, United States

🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

🇺🇸

Yale Cancer Center, New Haven, Connecticut, United States

and more 5 locations
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