Therapy Detail
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| Therapy Name | Enzalutamide |
| Synonyms | |
| Therapy Description |
Xtandi (enzalutamide) is a second-generation small molecule inhibitor of androgen receptor, thereby resulting in decreased tumor growth (PMID: 24009414, PMID: 25945058). Xtandi (enzalutamide) is FDA-approved for use in patients with castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, and non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Enzalutamide | Xtandi | MDV3100|ASP9785 | Hormone - Anti-androgens 54 | Xtandi (enzalutamide) is a second-generation small molecule inhibitor of androgen receptor, thereby resulting in decreased tumor growth (PMID: 24009414, PMID: 25945058). Xtandi (enzalutamide) is FDA-approved for use in patients with castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, and non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| APC inact mut | prostate cancer | decreased response | Enzalutamide | 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 |
| TP53 inact mut | prostate cancer | no benefit | Enzalutamide | 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 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03478904 | Phase I | Enzalutamide | Study to Compare Capsule and Liquid Formulations of Enzalutamide After Single Dose Administration Under Fasting Conditions in Prostate Cancer | Terminated | USA | 0 |
| NCT05075577 | Phase Ib/II | Enzalutamide + EPI-7386 Enzalutamide | EPI-7386 in Combination With Enzalutamide Compared With Enzalutamide Alone in Subjects With mCRPC | Active, not recruiting | USA | CAN | AUS | 0 |
| NCT02749903 | Phase II | Enzalutamide | Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers | Unknown status | USA | 0 |
| NCT06551324 | Phase III | Enzalutamide + PF-06821497 Enzalutamide Docetaxel | A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1). (MEVPRO-1) | Recruiting | USA | AUS | 3 |
| NCT02446405 | Phase III | Enzalutamide | Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer | Active, not recruiting | USA | NZL | IRL | GBR | CAN | AUS | 0 |
| NCT02685397 | Phase II | Enzalutamide Triptorelin Goserelin Leuprolide | Management of Castration-Resistant Prostate Cancer With Oligometastases | Recruiting | CAN | 0 |
| NCT04015622 | Phase II | Docetaxel Enzalutamide | PROTRACT (PROstate Cancer TReatment Optimization Via Analysis of Circulating Tumour DNA) STUDY (PROTRACT) | Recruiting | CAN | 0 |
| NCT01974765 | Phase II | Enzalutamide | Enzalutamide in Patients With Androgen Receptor Positive (AR+) Ovarian, Primary Peritoneal or Fallopian Tube Cancer and One, Two or Three Prior Therapies | Completed | USA | 0 |
| NCT02199197 | Phase II | Enzalutamide | Radium Ra 223 With Enzalutamide in Men With Metastatic Castration Refractory Prostate Cancer | Completed | USA | 0 |
| NCT02012296 | Phase Ib/II | Mifepristone Enzalutamide | Enzalutamide and Mifepristone in Treating Patients With Metastatic Hormone Resistant Prostate Cancer | Completed | USA | 0 |
| NCT02500901 | Phase I | Niraparib Enzalutamide | Enzalutamide and Niraparib in the Treatment of Metastatic Castrate-Resistant Prostate Cancer (CRPC) | Terminated | USA | 0 |
| NCT02215096 | Phase I | Enzalutamide GSK2636771 | Dose-finding Study of GSK2636771 When Administered in Combination With Enzalutamide in Male Subjects With Metastatic Castration-Resistant Prostate Cancer | Completed | USA | GBR | 0 |
| NCT04446117 | Phase III | Enzalutamide Atezolizumab + Cabozantinib Abiraterone + Prednisone | Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC (CONTACT-02) | Active, not recruiting | USA | POL | ITA | ISR | HUN | GRC | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG | 10 |
| NCT02929576 | Phase III | Paclitaxel Enzalutamide + Paclitaxel Enzalutamide | Efficacy and Safety Study of Enzalutamide in Combination With Paclitaxel Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel in Patients With Advanced, Diagnostic-Positive, Triple-Negative Breast Cancer (ENDEAR) | Withdrawn | USA | 0 |
| NCT04363164 | Phase II | Testosterone Enanthate Testosterone cypionate Enzalutamide | Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression | Recruiting | USA | 0 |
| NCT02319837 | Phase III | Leuprolide Enzalutamide | Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) | Active, not recruiting | USA | SWE | SVK | POL | NLD | ITA | GBR | FRA | FIN | ESP | DNK | CAN | BRA | AUT | AUS | 2 |
| NCT02278185 | Phase II | Goserelin Degarelix Histrelin acetate Triptorelin Leuprolide Enzalutamide | Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer | Active, not recruiting | USA | 0 |
| NCT02457910 | Phase Ib/II | Enzalutamide Enzalutamide + Taselisib | Taselisib and Enzalutamide in Treating Patients With Androgen Receptor Positive Triple-Negative Metastatic Breast Cancer | Terminated | USA | 0 |
| NCT02099864 | Phase II | Enzalutamide | Genetic and Molecular Mechanisms in Assessing Response in Patients With Prostate Cancer Receiving Enzalutamide Therapy | Completed | USA | 0 |
| NCT02204072 | Phase I | Enzalutamide Xentuzumab | BI836845 Plus Enzalutamide in Castrate Resistant Prostate Cancer (CRPC) | Completed | USA | NLD | GBR | ESP | 4 |
| NCT02138383 | Phase I | Enzalutamide Nab-paclitaxel Gemcitabine | Enzalutamide in Combination With Gemcitabine and Nab-Paclitaxel for the Treatment of Advanced Pancreatic Cancer | Completed | USA | 0 |
| NCT02028988 | Phase II | Enzalutamide | Enzalutamide + External Beam Rt For Prostate | 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 |
| NCT04332744 | Phase II | Enzalutamide + Talazoparib Enzalutamide | Enzalutamide Plus Talazoparib for the Treatment of Hormone Sensitive Prostate Cancer (ZZ-First) (ZZ-First) | Active, not recruiting | ESP | 0 |
| NCT04821622 | Phase III | Enzalutamide Enzalutamide + Talazoparib | Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC | Active, not recruiting | USA | TUR | SVK | NOR | NLD | ITA | HUN | GBR | FRA | FIN | ESP | DEU | CZE | CAN | BGR | BEL | AUS | ARG | 9 |
| NCT02268175 | Phase II | Enzalutamide Abiraterone Prednisone Leuprolide | Enzalutamide/Leuprolide +/- Abiraterone/Pred in Prostate | Completed | USA | 0 |
| NCT02023463 | Phase I | Goserelin Enzalutamide Leuprolide | Enzalutamide, Radiation Therapy and Hormone Therapy in Treating Patients With Intermediate or High-Risk Prostate Cancer | Active, not recruiting | USA | 0 |
| NCT03939689 | Phase II | Enzalutamide 131I-MIP-1095 + Enzalutamide | Study of I-131-1095 Radiotherapy in Combination With Enzalutamide in Patients With Metastatic Castration-resistant Prostate Cancer Who Are Chemotherapy Naive and Have Progressed on Abiraterone (ARROW) | Active, not recruiting | USA | CAN | 0 |
| NCT02203695 | Phase II | Enzalutamide | Randomized Salvage Radiation Therapy Plus Enzalutamide Post Prostatectomy | Active, not recruiting | USA | 0 |
| NCT04655365 | Phase II | Enzalutamide | Detecting Metastases by PyL PET/CT in Subjects Starting Enzalutamide for Untreated Castration Resistant Prostate Cancer. (PROSTEP-002) | Recruiting | CAN | 0 |
| NCT02750358 | Phase II | Enzalutamide | Feasibility Study of Adjuvant Enzalutamide for the Treatment of Early Stage AR (+) Triple Negative Breast Cancer | Active, not recruiting | USA | 0 |
| NCT04455750 | Phase III | Enzalutamide Goserelin + Leuprolide Enzalutamide + Rucaparib Degarelix | A Clinical Study Evaluating The Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant To Testosterone-Deprivation Therapy (CASPAR) | Active, not recruiting | USA | 0 |
| NCT04157088 | Phase II | Enzalutamide Darolutamide | Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC) (DaroAcT) | Terminated | USA | 0 |
| NCT06096870 | Phase II | Enzalutamide Enzalutamide + NHS-IL12 | Enzalutamide and M9241 in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy | Recruiting | USA | 0 |
| NCT02491411 | Phase I | Enzalutamide Dexamethasone | Dexamethasone Prior to Re-treatment With Enzalutamide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Enzalutamide and Docetaxel | Terminated | USA | 0 |
| NCT02125357 | Phase II | Enzalutamide Abiraterone | Sequencing Abiraterone and Enzalutamide in mCRPC | Completed | CAN | 0 |
| NCT04419402 | Phase II | Enzalutamide + lutetium Lu 177 vipivotide tetraxetan Enzalutamide | Enzalutamide With Lu PSMA-617 Versus Enzalutamide Alone in Men With Metastatic Castration-resistant Prostate Cancer (ENZA-p) | Active, not recruiting | AUS | 0 |
| NCT02256111 | Phase II | Enzalutamide | EXTEND Exercise Trial | Completed | USA | 0 |
| NCT03016312 | Phase III | Atezolizumab + Enzalutamide Enzalutamide | IMbassador250: A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostrate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen | Completed | USA | POL | ITA | HUN | GRC | GBR | FRA | ESP | DNK | DEU | CZE | CHE | CAN | BEL | AUT | AUS | 5 |
| NCT05404139 | Phase II | Enzalutamide | Duration of Enzalutamide and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT) | Active, not recruiting | CAN | 0 |
| NCT02300610 | Phase I | Cisplatin + Gemcitabine Enzalutamide | Enzalutamide in Combination With Gemcitabine and Cisplatin in Bladder Cancer | Completed | USA | 0 |
| NCT04647526 | Phase III | Abiraterone + Dexamethasone Abiraterone + Prednisone Enzalutamide PNT2002 | Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment (SPLASH) | Active, not recruiting | USA | SWE | NLD | GBR | FRA | CAN | 0 |
| NCT03809000 | Phase II | Goserelin Bicalutamide Enzalutamide Leuprolide | A Trial to See What the Results Are for Radiation Therapy and Hormone Therapy vs Radiation Therapy With Enhanced Hormone Therapy With Enzalutamide for Patients With PSA Recurrence After Surgery (STEEL) | Active, not recruiting | USA | 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 |
| 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 |
| 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 |
| NCT06059118 | Phase II | Eflornithine Eflornithine + Testosterone cypionate Enzalutamide | Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer | Recruiting | USA | 0 |
| NCT04876651 | Phase III | Docetaxel Enzalutamide 177Lu-J591 + Abiraterone + Prednisolone Abiraterone + Prednisone 177Lu-J591 + Abiraterone + Prednisone 177Lu-J591 + Enzalutamide Abiraterone + Prednisolone 177Lu-J591 + Docetaxel | The Present Study Aims to Compare Patients Who Receive the Investigational Product (177Lu-DOTA-rosopatamab) Plus Standard of Care, in Comparison to Standard of Care Only | Recruiting | NZL | AUS | 0 |
| NCT03344211 | Phase II | Enzalutamide + Radium Ra 223 dichloride Enzalutamide | Enzalutamide With or Without Radium Ra 223 Dichloride in Patients With Metastatic, Castration-Resistant Prostate Cancer | Active, not recruiting | USA | 0 |
| NCT02003924 | Phase III | Enzalutamide | Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer | Active, not recruiting | USA | TUR | SWE | SVK | POL | NZL | NLD | ITA | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CAN | BRA | BEL | AUT | AUS | ARG | 11 |
| NCT01867333 | Phase II | PROSTVAC-F-TRICOM Enzalutamide | Enzalutamide With or Without Vaccine Therapy for Advanced Prostate Cancer | Completed | USA | 0 |
| NCT06378866 | Phase II | Degarelix Goserelin Darolutamide Relugolix Triptorelin Enzalutamide Histrelin acetate Abiraterone + Prednisone Leuprolide Apalutamide | Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial (DIVINE) | Recruiting | USA | 0 |
| NCT04787744 | Phase II | Goserelin Degarelix Relugolix Nilutamide Triptorelin Histrelin acetate Docetaxel + Prednisone Leuprolide Apalutamide Abiraterone + Prednisone Flutamide Abiraterone + Methylprednisolone Bicalutamide Docetaxel Enzalutamide | Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer (VA STARPORT) | Recruiting | USA | 0 |
| NCT06496581 | Phase III | Enzalutamide Abiraterone + Docetaxel + Prednisone Enzalutamide + lutetium Lu 177 vipivotide tetraxetan Abiraterone + Docetaxel + lutetium Lu 177 vipivotide tetraxetan + Prednisone Abiraterone + lutetium Lu 177 vipivotide tetraxetan + Prednisone Apalutamide + lutetium Lu 177 vipivotide tetraxetan Darolutamide + Docetaxel + lutetium Lu 177 vipivotide tetraxetan Darolutamide + Docetaxel Abiraterone + Prednisone Apalutamide | Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders) | Not yet recruiting | FRA | 0 |
| NCT02452008 | Phase II | Galunisertib Enzalutamide | Study of TGF-Beta Receptor Inhibitor LY2157299 and Enzalutamide in Metastatic Castration-resistant Prostate Cancer | Active, not recruiting | USA | 0 |
| NCT02407054 | Phase II | Enzalutamide LY3023414 | A Study of Enzalutamide and LY3023414 in Men With Prostate Cancer | Completed | USA | 0 |
| NCT04381832 | Phase Ib/II | Enzalutamide + Etrumadenant + Zimberelimab Docetaxel + Etrumadenant + Zimberelimab AB680 + Etrumadenant + Zimberelimab AB680 + Etrumadenant Enzalutamide Docetaxel Etrumadenant + Zimberelimab | Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer (ARC-6) | Completed | USA | CAN | 0 |
| NCT01977651 | FDA approved | Enzalutamide | A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide | Completed | USA | SWE | NZL | ITA | ISR | HUN | GBR | FRA | FIN | ESP | DEU | CZE | CAN | BEL | AUS | ARG | 4 |
| NCT02885649 | Phase 0 | Enzalutamide | Enzalutamide Before Surgery in Treating Patients With Kidney Cancer | Terminated | 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 |
| NCT02489123 | Phase I | Enzalutamide | Enzalutamide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma | Terminated | USA | 0 |
| NCT01927627 | Phase II | Enzalutamide | Enzalutamide in Patients With High-risk Prostate Cancer | Completed | USA | 0 |
| NCT02446444 | Phase III | Enzalutamide | Enzalutamide in Androgen Deprivation Therapy With Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer | Active, not recruiting | USA | SVN | NZL | IRL | GBR | ESP | BEL | AUT | AUS | 0 |
| NCT06099769 | Phase II | Capecitabine Paclitaxel Enzalutamide Enzalutamide + Mifepristone Eribulin Carboplatin | A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer | Recruiting | USA | 0 |
| NCT02438007 | Phase III | Galeterone Enzalutamide | A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC | Terminated | USA | ITA | GBR | FRA | ESP | CAN | BEL | AUS | 0 |
| NCT02194842 | Phase III | Enzalutamide Enzalutamide + Radium Ra 223 dichloride | Phase III Radium 223 mCRPC-PEACE III (PEACE III) | Active, not recruiting | POL | NOR | ITA | IRL | GBR | FRA | ESP | DNK | CHE | CAN | BRA | BEL | 0 |
| NCT03016741 | FDA approved | Enzalutamide Abiraterone + Prednisone | Cognitive Effects of Androgen Receptor Directed Therapies for Advanced Prostate Cancer | Unknown status | USA | 0 |
| NCT01942837 | Phase II | Enzalutamide | Phase II Trial of Enzalutamide for Castrate-resistant Prostate Cancer With Correlative Assessment of Androgen Receptor Signaling | Completed | USA | 0 |
| NCT05683964 | Phase I | Apalutamide Darolutamide Enzalutamide | Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression | Recruiting | USA | 0 |
| NCT05526248 | Phase II | Enzalutamide Darolutamide | A Study Called ARAMON to Learn to What Extent Does Study Treatment With Darolutamide Affects Testosterone Levels in Men With Prostate Cancer That Had Not Been Treated With Hormonal Therapy Compared to Treatment With Enzalutamide (ARAMON) | Recruiting | USA | 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 |
| NCT03480646 | Phase Ib/II | Enzalutamide Abiraterone + CPI-1205 + Prednisone CPI-1205 + Enzalutamide | ProSTAR: A Study Evaluating CPI-1205 in Patients With Metastatic Castration Resistant Prostate Cancer | Unknown status | USA | 0 |
| NCT02799745 | Phase II | Enzalutamide | A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance (ENACT) (ENACT) | Completed | USA | CAN | 0 |
| NCT06320067 | Phase III | Darolutamide + lutetium Lu 177 vipivotide tetraxetan Abiraterone + lutetium Lu 177 vipivotide tetraxetan + Prednisolone Apalutamide + lutetium Lu 177 vipivotide tetraxetan Abiraterone + Docetaxel + lutetium Lu 177 vipivotide tetraxetan + Prednisolone Darolutamide Abiraterone + Docetaxel + Prednisone Enzalutamide + lutetium Lu 177 vipivotide tetraxetan Docetaxel + Niraparib and abiraterone acetate + Prednisolone Niraparib and abiraterone acetate + Prednisone Docetaxel + Enzalutamide + lutetium Lu 177 vipivotide tetraxetan Darolutamide + Docetaxel + lutetium Lu 177 vipivotide tetraxetan Apalutamide + Docetaxel + lutetium Lu 177 vipivotide tetraxetan Enzalutamide Apalutamide + Docetaxel Docetaxel + Enzalutamide Apalutamide Abiraterone + Prednisone Darolutamide + Docetaxel | A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer (STAMPEDE2) | Recruiting | GBR | 0 |
| NCT03850795 | Phase III | Enzalutamide HC-1119 | HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC) | Terminated | USA | POL | NLD | ITA | GBR | FRA | FIN | ESP | DNK | DEU | CAN | AUT | AUS | 1 |
| 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 |
| NCT04142060 | Phase II | Enzalutamide | Targeting PAM50 Her2-Enriched Phenotype With Enzalutamide in Hormone Receptor-Positive/Her2-Negative Metastatic Breast Cancer (ARIANNA) | Terminated | ESP | 0 |
| NCT02528643 | Phase II | Enzalutamide | A Study to Assess the Efficacy and Safety of Enzalutamide in Subjects With Advanced Hepatocellular Carcinoma | Completed | USA | ITA | GBR | ESP | CAN | 4 |
| NCT02058706 | Phase II | Goserelin Bicalutamide Enzalutamide Leuprolide | LHRH Analogue Therapy With Enzalutamide or Bicalutamide in Treating Patients With Metastatic Hormone Sensitive Prostate Cancer | Completed | USA | 0 |
| NCT02057939 | Phase II | Enzalutamide Leuprolide | Salvage Therapeutic Radiation With Enzalutamide and ADT in Men With Recurrent Prostate Cancer (STREAM) | Completed | USA | 0 |
| NCT04986423 | Phase II | Enzalutamide + ZEN-3694 Enzalutamide | ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer | Recruiting | USA | 1 |
| NCT03834493 | Phase III | Enzalutamide + Pembrolizumab Enzalutamide | Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641) | Active, not recruiting | USA | TUR | POL | NZL | NLD | ITA | ISR | IRL | HUN | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BGR | AUT | AUS | ARG | 8 |
| NCT02532114 | Phase I | Enzalutamide Niclosamide | Niclosamide and Enzalutamide in Treating Patients With Androgen Receptor Splice Variant-Positive, Castration-Resistant, Metastatic Prostate Cancer | Completed | USA | 0 |
| NCT05422911 | Phase II | Enzalutamide Abiraterone Apalutamide | Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer. | Not yet recruiting | USA | 0 |
| NCT02384382 | Phase II | Enzalutamide | A Positron Emission Tomography/Computed Tomography (PET/CT) Bone Imaging Study in Patients Receiving Enzalutamide for Castration-Resistant Prostate Cancer (CRPC) | Completed | USA | 0 |
| NCT03834519 | Phase III | Abiraterone + Prednisone Enzalutamide Olaparib + Pembrolizumab | Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010) (KEYLYNK-010) | Completed | USA | NZL | NLD | ITA | ISR | IRL | GBR | FRA | ESP | DEU | CAN | BRA | AUT | AUS | ARG | 5 |
| NCT02441517 | FDA approved | Enzalutamide | A Study of Enzalutamide Re-treatment in Metastatic Castration-resistant Prostate Cancer After Docetaxel Treatment in Patients Who Have Previously Received Enzalutamide | Terminated | USA | 0 |
| NCT01362374 | Phase I | Enzalutamide Paclitaxel Docetaxel Ipatasertib Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab | Safety and Pharmacology Of GDC-0068 in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Patients With Advanced Solid Tumors | Completed | USA | GBR | FRA | ESP | 0 |
| NCT06582628 | Phase II | Enzalutamide Enzalutamide + Talazoparib | Talazoparib Plus Enzalutamide After Progression to Abiraterone in Metastatic Prostate Cancer: (TEAM PC) (TEAM PC) | Recruiting | ESP | 0 |
| NCT02555189 | Phase Ib/II | Ribociclib Enzalutamide | Enzalutamide With and Without Ribociclib for Metastatic, Castrate-Resistant, Chemotherapy-Naive Prostate Cancer That Retains RB Expression | Completed | USA | 0 |
| NCT02507570 | Phase II | Enzalutamide Radium Ra 223 dichloride | Open Label Phase Two Study of Enzalutamide With Concurrent Administration of Radium Ra 223 Dichloride in Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Symptomatic Bone Metastasis | Completed | 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 |
| NCT02429193 | Phase II | Enzalutamide Abiraterone + Prednisone | Biomarkers of Androgen Response and Resistance In Evolution During a Rising PSA (BARRIER-P) | Completed | CAN | 0 |
| NCT06257693 | Phase I | Enzalutamide | Enzalutamide Implants (Enolen) in Patients With Prostate Cancer | Recruiting | USA | 0 |
| NCT06136650 | Phase III | Abiraterone + Prednisone Dexamethasone + Fludrocortisone + ODM-208 Enzalutamide | A Study of MK-5684 Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004) | Recruiting | USA | TUR | SWE | SVK | ROU | NZL | LVA | LTU | ITA | ISR | IRL | HUN | GRC | GBR | FRA | EST | ESP | DEU | CZE | BRA | AUS | 16 |
| NCT05726292 | Phase II | Enzalutamide Enzalutamide + Relacorilant | A Study of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer | Recruiting | USA | 0 |
| NCT02090114 | Phase II | Testosterone Abiraterone Enzalutamide | RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistant (The RESTORE Study) | Completed | USA | 0 |
| NCT02642913 | Phase Ib/II | Enzalutamide Sorafenib | Study of Enzalutamide With and Without Sorafenib in Advanced Hepatocellular Carcinoma Patients | Completed | USA | 0 |
| NCT02607228 | Phase Ib/II | Enzalutamide Exemestane + GS-5829 | Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 as a Single Agent and In Combination With Enzalutamide in Participants With Metastatic Castrate-Resistant Prostate Cancer | Terminated | 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 |
| NCT02064582 | Phase II | Leuprolide Enzalutamide | Enzalutamide and Hormone Therapy Before, During, and After Radiation for High Risk Localized Prostate Cancer | Completed | USA | 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 |
| NCT02676986 | Phase II | Enzalutamide + Exemestane Exemestane Enzalutamide | Short-term Preoperative Treatment With Enzalutamide, Alone or in Combination With Exemestane in Primary Breast Cancer (ARB) | Completed | USA | IRL | GBR | ESP | DEU | 0 |
| NCT02605863 | Phase II | Enzalutamide | Enzalutamide for Bladder Cancer Chemoprevention | Terminated | USA | 0 |
| NCT02960022 | Phase II | Abiraterone + Enzalutamide + Prednisone Enzalutamide | A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study | Recruiting | USA | TUR | SWE | SVK | ROU | POL | NZL | NOR | NLD | ITA | ISR | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG | 13 |
| NCT04191096 | Phase III | Enzalutamide + Pembrolizumab Enzalutamide | Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991) | Active, not recruiting | USA | TUR | POL | NZL | NLD | ITA | ISR | IRL | GBR | FRA | FIN | ESP | DNK | DEU | CHE | CAN | BRA | AUT | AUS | 10 |
| NCT04335682 | Phase II | Darolutamide Enzalutamide | Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide | Recruiting | USA | 0 |
| NCT02677896 | Phase III | Enzalutamide | A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) | Completed | USA | SWE | SVK | ROU | POL | NZL | NLD | ITA | ISR | GBR | FRA | FIN | ESP | DNK | DEU | CAN | BEL | AUS | ARG | 5 |
| 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 |
| 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 |
| NCT04237584 | Phase III | Darolutamide Darolutamide + Radium Ra 223 dichloride Enzalutamide Enzalutamide + Radium Ra 223 dichloride | A Study Comparing ARB With Radium-223 vs ARB Therapy With Placebo and the Effect Upon Survival for mCRPC Patients (ESCALATE) | Terminated | USA | 0 |
| NCT02286921 | Phase II | Enzalutamide Testosterone | Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance | Completed | USA | 0 |
| NCT06629779 | Phase III | Enzalutamide Enzalutamide + PF-06821497 | A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer. | Recruiting | USA | 2 |
| 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 |
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