Therapy Detail
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| Therapy Name | Abiraterone |
| Synonyms | |
| Therapy Description |
Zytiga (abiraterone) inhibits cytochrome P-450c17, resulting in decreased androgen synthesis (PMID: 25560485). Zytiga (abiraterone) is FDA approved for patients with metastatic castration-resistant prostate cancer (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Abiraterone | Zytiga | CB7630 | Hormone - Anti-androgens 54 | Zytiga (abiraterone) inhibits cytochrome P-450c17, resulting in decreased androgen synthesis (PMID: 25560485). Zytiga (abiraterone) is FDA approved for patients with metastatic castration-resistant prostate cancer (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| TP53 inact mut | prostate cancer | no benefit | Abiraterone | Clinical Study - Cohort | Actionable | In a clinical study, treatment with either Xtandi (enzalutamide) or Zytiga (abiraterone) in patients with metastatic castration-resistant prostate cancer harboring a TP53 inactivating mutation, detected via circulating tumor cells, demonstrated a shorter progression-free survival (3.0 vs 8.7mo; P<0.0001) and overall survival (7.8 vs 26.7mo; P<0.0001) and fewer patients with a PSA response greater than or equal to 50% (15.4 vs 46.8%; P=0.008) compared to those patients with wild-type TP53 (PMID: 30209161). | 30209161 |
| APC inact mut | prostate cancer | decreased response | Abiraterone | Clinical Study | Actionable | In a clinical study, metastatic castrate-resistant prostate cancer patients harboring a Wnt pathway activating alteration demonstrated shorter median overall survival (23.6 mo vs 27.7 mo) and median time to PSA progression (6.5 mo vs 9.6 mo) following Zytiga (abiraterone) or Xtandi (enzalutamide) treatment compared to patients without Wnt pathway alterations, and APC or RNF43 inactivating mutations were independently associated with increased hazard of PSA progression (aHR 1.83; p=0.004) (PMID: 31176623). | 31176623 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT01949337 | Phase III | Abiraterone Prednisone Enzalutamide | Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer | Active, not recruiting | USA | CAN | 1 |
| NCT01845792 | Phase II | Cabazitaxel Abiraterone | Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Prostate Cancer | Terminated | USA | 0 |
| NCT01681433 | Phase II | Prednisone Abiraterone Apatorsen | OGX-427 in Metastatic Castrate-Resistant Prostate Cancer With Prostate-Specific Antigen Progression While Receiving Abiraterone | Terminated | USA | CAN | 0 |
| NCT02379390 | Phase II | Prednisone Abiraterone Enzalutamide Cabazitaxel | 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 Enz (PRIMCAB) | Terminated | USA | CAN | 0 |
| NCT02987543 | Phase III | Olaparib Enzalutamide Abiraterone | Study of Olaparib (Lynparza) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study) | Completed | USA | TUR | SWE | NOR | NLD | ITA | ISR | GBR | FRA | ESP | DNK | DEU | CAN | BRA | AUT | AUS | ARG | 3 |
| NCT01717053 | Phase II | Leuprolide Abiraterone Prednisone Goserelin | Abiraterone, Radiotherapy and Short-Term Androgen Deprivation in Unfavorable Localized Prostate Cancer | Completed | USA | 0 |
| NCT01685125 | Phase II | Dasatinib Abiraterone | Abiraterone Acetate and Prednisone With or Without Dasatinib in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer | Unknown status | USA | 0 |
| NCT02268175 | Phase II | Enzalutamide Abiraterone Prednisone Leuprolide | Enzalutamide/Leuprolide +/- Abiraterone/Pred in Prostate | Completed | USA | 0 |
| NCT01553188 | Phase II | Prednisone Abiraterone Trebananib | AMG 386 and Abiraterone for Advanced Prostate Cancer | Completed | USA | 0 |
| NCT01848067 | Phase Ib/II | Abiraterone Prednisone Alisertib | Alisertib, Abiraterone Acetate and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer | Completed | USA | 0 |
| NCT02254785 | Phase II | Abiraterone Enzalutamide Cabazitaxel | Cabazitaxel vs Abiraterone or Enzalutamide in Patients With Poor Prognosis Metastatic Castration-resistant Prostate Cancer | Unknown status | CAN | AUS | 0 |
| NCT03072238 | Phase III | Abiraterone Abiraterone + Ipatasertib | Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer | Completed | USA | POL | NOR | ITA | ISR | IRL | HUN | GRC | GBR | FRA | ESP | DNK | CAN | BRA | BEL | AUT | AUS | 9 |
| NCT03678025 | Phase III | Docetaxel Nilutamide Triptorelin Bicalutamide Leuprolide Degarelix Goserelin Flutamide Prednisone Abiraterone Histrelin acetate | Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer | Recruiting | USA | CHE | 3 |
| NCT01485861 | Phase II | Apitolisib Abiraterone Ipatasertib | Study of GDC-0068 Or GDC-0980 With Abiraterone Acetate Versus Abiraterone Acetate in Patients With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy | Completed | USA | ROU | NLD | ITA | GRC | GBR | FRA | ESP | CZE | 0 |
| NCT01751451 | Phase II | Abiraterone Degarelix | 3-arm Study of Abiraterone Acetate Alone, Abiraterone Acetate Plus Degarelix, a GnRH Antagonist, and Degarelix Alone for Patients With Prostate Cancer With a Rising PSA or a Rising PSA and Nodal Disease Following Definitive Radical Prostatectomy | Completed | USA | 0 |
| NCT02034552 | Phase II | Prednisone Radium Ra 223 dichloride Enzalutamide Abiraterone | A Randomized Phase IIa Efficacy and Safety Study of Radium-223 Dichloride With Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (CRPC) | Completed | USA | 0 |
| NCT01786265 | Phase II | Goserelin Degarelix Abiraterone Prednisone Leuprolide | Finite Androgen Ablation vs. Finite Androgen Ablation in Combination With Abiraterone Acetate and Prednisone | Active, not recruiting | USA | 0 |
| NCT01543776 | Phase II | Abiraterone | Food Effect Study of Abiraterone Acetate for Treatment of Patients With Castration-Resistant Prostate Cancer | Completed | USA | 1 |
| NCT01517802 | Phase III | Abiraterone | A Study That Provides Long-term Safety Follow-up and Examines Long-term Exposure to Abiraterone Acetate | Completed | USA | SWE | GBR | ESP | DEU | BEL | AUS | 0 |
| NCT02788201 | Phase II | Erlotinib Thiotepa Imatinib Dacarbazine Arsenic trioxide Idarubicin Mitomycin C Thioguanine Mercaptopurine Methotrexate Cladribine Epirubicin Gemcitabine Doxorubicin Bleomycin Etoposide Gefitinib Daunorubicin Lomustine Sorafenib Sunitinib Ifosfamide Asparaginase Ixabepilone Abiraterone Azacitidine Ruxolitinib Decitabine Axitinib Estramustine Floxuridine Lapatinib Carmustine Fludarabine Nilotinib Cisplatin Vismodegib Vandetanib Melphalan Busulfan Carboplatin Toremifene Crizotinib Dactinomycin Temsirolimus Vorinostat Romidepsin Fluorouracil Irinotecan Bortezomib Tamoxifen Topotecan Chlorambucil Pentostatin Eribulin Carfilzomib Vemurafenib Hydroxyurea Exemestane Vincristine Sulfate Dasatinib Mitoxantrone Vinblastine Cytarabine Tretinoin Clofarabine Teniposide Docetaxel Pazopanib Oxaliplatin Streptozocin Paclitaxel Bendamustine Mechlorethamine Mitotane | Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma | Completed | USA | 0 |
| NCT02125357 | Phase II | Enzalutamide Abiraterone | Sequencing Abiraterone and Enzalutamide in mCRPC | Completed | CAN | 0 |
| NCT06120491 | Phase III | Enzalutamide + Saruparib Abiraterone + Saruparib Darolutamide + Saruparib Darolutamide Enzalutamide Abiraterone | AZD5305 vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents (EvoPAR-PR01) | Recruiting | USA | TUR | SWE | POL | NLD | ITA | HUN | GBR | FRA | FIN | ESP | DEU | CAN | BRA | BEL | AUT | AUS | 10 |
| NCT02975934 | Phase III | Rucaparib Docetaxel Enzalutamide Abiraterone | A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency (TRITON3) | Active, not recruiting | USA | ITA | ISR | IRL | GBR | FRA | ESP | DNK | DEU | CAN | BEL | AUS | 0 |
| NCT03878524 | Phase I | Oxaliplatin Palbociclib Vemurafenib Sirolimus Tretinoin Celecoxib Ipilimumab Ruxolitinib Dasatinib Abiraterone Idelalisib Trametinib Imatinib Erlotinib Carboplatin Olaparib Panobinostat Bortezomib Afatinib Fluorouracil Vorinostat Pembrolizumab Leucovorin Enzalutamide Ponatinib Nivolumab Everolimus Sunitinib Cabazitaxel Cabozantinib Lenvatinib Pertuzumab Sorafenib Venetoclax Bevacizumab | A Personalized Medicine Study for Patients With Advanced Cancer of the Breast, Prostate, Pancreas or Those With Refractory Acute Myelogenous Leukemia (SMMART) | Terminated | USA | 0 |
| NCT01972217 | Phase II | Prednisone Abiraterone Olaparib | Ph II Study to Evaluate Olaparib With Abiraterone in Treating Metastatic Castration Resistant Prostate Cancer | Completed | USA | POL | NLD | ITA | GBR | FRA | ESP | CZE | CAN | BEL | 1 |
| NCT03732820 | Phase III | Abiraterone Abiraterone + Olaparib | Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer | Active, not recruiting | USA | TUR | SVK | NLD | ITA | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BEL | AUS | 3 |
| NCT02090114 | Phase II | Testosterone Abiraterone Enzalutamide | RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistant (The RESTORE Study) | Completed | USA | 0 |
| NCT01961843 | Phase I | Prednisone Abiraterone | Abiraterone Acetate for Castrate Resistant Prostate Cancer | Active, not recruiting | USA | 0 |
| NCT02043678 | Phase III | Prednisone Abiraterone Radium Ra 223 dichloride | Radium-223 Dichloride and Abiraterone Acetate Compared to Placebo and Abiraterone Acetate for Men With Cancer of the Prostate When Medical or Surgical Castration Does Not Work and When the Cancer Has Spread to the Bone, Has Not Been Treated With Chemotherapy and is Causing no or Only Mild Symptoms | Completed | USA | SWE | POL | NOR | NLD | ITA | ISR | GBR | FRA | FIN | ESP | DEU | CAN | BRA | BEL | AUS | 3 |
| NCT04493853 | Phase III | Abiraterone + Capivasertib Abiraterone | Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency (CAPItello-281) | Active, not recruiting | USA | TUR | SVK | POL | NLD | ISR | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BGR | BEL | AUT | AUS | ARG | 14 |
| NCT03458247 | Phase II | Abiraterone | Study of Dose Escalation of Abiraterone Actetate in Prostate Cancer (OPTIMABI) | Completed | FRA | 0 |
| NCT02257736 | Phase III | Abiraterone + Apalutamide Abiraterone | An Efficacy and Safety Study of JNJ56021927 in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC) | Active, not recruiting | USA | NLD | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUS | ARG | 5 |
| NCT04844749 | Phase III | Abiraterone Enzalutamide VERU-111 | Efficacy Evaluation of VERU-111 for mCRPC in Patients Who Have Failed at Least One Androgen Receptor Targeting Agent (VERU-111) | Terminated | USA | 0 |
| NCT02025010 | Phase II | Abiraterone | Phase II Clinical Trial of Abiraterone Acetate Without Exogenous Glucocorticoids in Men With Castration-resistant Prostate Cancer With Correlative Assessment of Hormone Intermediates. | Active, not recruiting | USA | 0 |
| NCT01503229 | Phase II | Prednisone Abiraterone | Abiraterone Acetate in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer | Completed | USA | 0 |
| NCT02217566 | Phase II | Abiraterone | Study of Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy | Completed | BRA | 0 |
| NCT06136624 | Phase III | Dexamethasone + Fludrocortisone + ODM-208 Enzalutamide Abiraterone | Study of MK-5684 Versus Alternative NHA in mCRPC (MK-5684-003) | Recruiting | USA | TUR | SWE | POL | NZL | NOR | NLD | ITA | ISR | IRL | HUN | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BRA | AUT | AUS | ARG | 12 |
| NCT06060587 | Phase II | Abiraterone Abiraterone + Docetaxel | Randomized Phase II Study of ADT + Abiraterone vs ADT + Docetaxel + Abiraterone | Active, not recruiting | USA | 0 |
| NCT03903835 | Phase III | Docetaxel Cabazitaxel Carboplatin Abiraterone Enzalutamide | ProBio: A Biomarker Driven Study in Patients With Metastatic Castrate Resistant Prostate Cancer (ProBio) | Recruiting | SWE | NOR | CHE | BEL | 0 |
| NCT02353715 | Phase I | Abiraterone Enzalutamide Sipuleucel-T | Men With Metastatic Castrate-Resistant Prostate Cancer Treated With Either Sipuleucel-T (Provenge), Abiraterone Acetate (Zytiga) or Enzalutamide (Xtandi) Undergoing Cardiopulmonary EXercise Testing | Completed | USA | 0 |
| NCT02403505 | Phase II | Enzalutamide Abiraterone Prednisone Degarelix | Discovery Stage Clinical Study About Oncology Drugs and Single Nucleotide Polymorphisms | Active, not recruiting | USA | 0 |
| NCT05422911 | Phase II | Enzalutamide Abiraterone Apalutamide | Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer. | Not yet recruiting | USA | 0 |
| NCT02415621 | Phase I | Abiraterone | Adaptive Abiraterone Therapy for Metastatic Castration Resistant Prostate Cancer | Active, not recruiting | USA | 0 |
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