{"id":"abiraterone-acetate-aa","safety":{"commonSideEffects":[{"rate":"17","effect":"Hypokalemia"},{"rate":"22","effect":"Hypertension"},{"rate":"25","effect":"Fluid retention/edema"},{"rate":"41","effect":"Fatigue"},{"rate":"17","effect":"Joint swelling/pain"},{"rate":"22","effect":"Diarrhea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Abiraterone acetate is a prodrug that is converted to abiraterone in vivo. It selectively inhibits 17α-hydroxylase/17,20-lyase (CYP17A1), an enzyme critical for androgen biosynthesis in the testes, adrenal glands, and prostate cancer cells. By blocking this enzyme, it suppresses intratumoral and circulating androgens, slowing prostate cancer progression in patients who have become resistant to chemical castration.","oneSentence":"Abiraterone acetate inhibits CYP17A1, a key enzyme in androgen synthesis, thereby reducing testosterone production in patients with castration-resistant prostate cancer.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:58:40.046Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Metastatic castration-resistant prostate cancer (mCRPC)"},{"name":"High-risk castration-sensitive prostate cancer (in combination with androgen deprivation therapy)"}]},"trialDetails":[{"nctId":"NCT03431350","phase":"PHASE2","title":"A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2018-03-02","conditions":"Prostatic Neoplasms, Castration-Resistant","enrollment":136},{"nctId":"NCT06421935","phase":"PHASE1","title":"M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)","status":"ACTIVE_NOT_RECRUITING","sponsor":"EMD Serono Research & Development Institute, Inc.","startDate":"2024-08-07","conditions":"Advanced Solid Tumor","enrollment":141},{"nctId":"NCT04497844","phase":"PHASE3","title":"A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2020-09-23","conditions":"Metastatic Castration-sensitive Prostate Cancer","enrollment":696},{"nctId":"NCT02257736","phase":"PHASE3","title":"An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Aragon Pharmaceuticals, Inc.","startDate":"2014-11-26","conditions":"Prostatic Neoplasms","enrollment":982},{"nctId":"NCT03748641","phase":"PHASE3","title":"A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2019-01-25","conditions":"Castration-Resistant Prostatic Cancer","enrollment":765},{"nctId":"NCT02123758","phase":"PHASE1","title":"A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Aragon Pharmaceuticals, 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Research & Development, LLC","startDate":"","conditions":"Metastatic Castration-resistant Prostate Cancer","enrollment":""},{"nctId":"NCT02025010","phase":"PHASE2","title":"Study of Abiraterone Acetate Without Exogenous Glucocorticoids in Men With Castration-resistant Prostate Cancer","status":"COMPLETED","sponsor":"Dana-Farber Cancer Institute","startDate":"2014-01-27","conditions":"Castration-resistant Prostate Cancer","enrollment":60},{"nctId":"NCT04691804","phase":"PHASE3","title":"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2021-03-18","conditions":"Metastatic Castration-Resistant Prostate Cancer (mCRPC)","enrollment":496},{"nctId":"NCT05393791","phase":"PHASE2","title":"Phase II Randomised Controlled Trial of Patient-specific Adaptive vs. Continuous Abiraterone or eNZalutamide in mCRPC","status":"RECRUITING","sponsor":"Leiden University Medical Center","startDate":"2022-11-10","conditions":"Prostatic Neoplasms, Castration-Resistant","enrollment":168},{"nctId":"NCT06329830","phase":"PHASE1, PHASE2","title":"177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer","status":"WITHDRAWN","sponsor":"Baptist Health South Florida","startDate":"2024-10","conditions":"Metastatic Prostate Cancer, Castration-resistant Prostate Cancer, Metastatic Castration-resistant Prostate Cancer","enrollment":""},{"nctId":"NCT04887506","phase":"PHASE3","title":"TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer","status":"COMPLETED","sponsor":"Tavanta Therapeutics","startDate":"2021-05-05","conditions":"Metastatic Castration-resistant Prostate Cancer, Metastatic Castration-sensitive Prostate Cancer, Metastatic Prostate Cancer","enrollment":107},{"nctId":"NCT06099990","phase":"PHASE1","title":"Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets (I) and Prednisone Tablets (AA-P) Versus Placebo Combined With AA-P in Treatment of High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)","status":"NOT_YET_RECRUITING","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2023-10","conditions":"High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)","enrollment":660},{"nctId":"NCT02740985","phase":"PHASE1","title":"A Phase 1 Clinical Study of AZD4635 in Patients With Advanced Solid Malignancies","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2016-06-17","conditions":"Advanced Solid Malignancies, Non-Small Cell Lung Cancer (NSCLC), Metastatic Castrate-Resistant Prostate Carcinoma (mCRPC)","enrollment":313},{"nctId":"NCT03551782","phase":"PHASE1","title":"A Study of Cetrelimab (JNJ-63723283), a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, Administered in Combination With Apalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2018-06-28","conditions":"Castration-Resistant Prostatic Neoplasms","enrollment":33},{"nctId":"NCT02730975","phase":"PHASE1","title":"Pharmacokinetic Food-effect Study of Abiraterone Acetate (AA) in Castration Resistant Prostate Cancer","status":"COMPLETED","sponsor":"Fundación Pública Andaluza para la gestión de la Investigación en Sevilla","startDate":"2014-05-12","conditions":"Prostate Cancer","enrollment":42},{"nctId":"NCT01867710","phase":"PHASE2","title":"Abiraterone With Different Steroid Regimens for Side Effect Related to Mineralcorticoid Excess Prevention in Prostate Cancer Prior to Chemotherapy","status":"COMPLETED","sponsor":"Janssen Pharmaceutica N.V., Belgium","startDate":"2013-07-16","conditions":"Prostate Cancer","enrollment":164},{"nctId":"NCT03449719","phase":"NA","title":"Phase II Randomized Trial of Radiation Therapy in Oligometastatic mCRPC Prostate Cancer (ARTO)","status":"UNKNOWN","sponsor":"Lorenzo Livi","startDate":"2018-05-01","conditions":"Rate of PSA Response in Oligometastatic,CRPC Undergoing SBRT in Combination With Abiraterone Acetate (AA), Compared to Patients Treated With AA Alone","enrollment":174},{"nctId":"NCT03145285","phase":"PHASE2","title":"Activity of Abiraterone Acetate in the Management of Cushing's Syndrome in Patients With Adrenocortical Carcinoma","status":"UNKNOWN","sponsor":"Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia","startDate":"2017-04-18","conditions":"Cushing Syndrome, Adrenocortical Carcinoma","enrollment":10},{"nctId":"NCT02656615","phase":"PHASE2","title":"Abiraterone-Rechallenge Study for CRPC Patients","status":"TERMINATED","sponsor":"Aurelius Omlin","startDate":"2016-01","conditions":"Prostate Cancer","enrollment":4},{"nctId":"NCT02928432","phase":"PHASE2","title":"SWITCH: Study of the Prednisone to Dexamethasone Change in mCRPC Patients Treated With Abiraterone","status":"COMPLETED","sponsor":"Centro Nacional de Investigaciones Oncologicas CARLOS III","startDate":"2013-06","conditions":"Prostate Cancer","enrollment":26},{"nctId":"NCT01088529","phase":"PHASE2","title":"Neo-adjuvant Abiraterone + Luteinizing Hormone-Releasing Hormone (LHRH) Versus LHRH in Prostate Cancer","status":"COMPLETED","sponsor":"Cougar Biotechnology, Inc.","startDate":"2009-12","conditions":"Prostate Cancer","enrollment":66}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":5,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Abiraterone Acetate (AA)","genericName":"Abiraterone Acetate (AA)","companyName":"Janssen Research & Development, LLC","companyId":"johnson-johnson","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Abiraterone Acetate (AA) is used to treat castration-resistant prostate cancer (CRPC) and oligometastatic CRPC. It is also being studied in combination with other treatments, such as patient-specific adaptive therapy and enzalutamide, in clinical trials for CRPC.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}