Apalutamide
Information
- Drug Name
- Apalutamide
- Description
- Entry(CIViC)
- 1
CIViC
| Disease | Mutation | EL | ET | ED | CS | VO | TR | Pubmed | Links |
|---|---|---|---|---|---|---|---|---|---|
| prostate cancer |
AR p.Phe877Leu (p.F877L) ( ENST00000374690.9, ENST00000396044.8 ) AR p.Phe877Leu (p.F877L) ( ENST00000374690.9, ENST00000396044.8 ) |
D |
Predictive
|
Supports
|
Resistance | Somatic | 4 | 23779130 | Detail |
Annotation
| Description | Associated Genes | Associated Variants | Sensitivity | Supported | Source | Links |
|---|---|---|---|---|---|---|
| Mutations F876L in the ligand binding domain of th... | AR |
AR p.Phe877Leu (p.F877L) ( ENST00000374690.9, ENST00000396044.8 ) AR p.Phe877Leu (p.F877L) ( ENST00000374690.9, ENST00000396044.8 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| NCT ID | Status | Phase | Summary | Start date | Completion date |
|---|---|---|---|---|---|
| NCT01946204 | Active, not recruiting | Phase 3 | A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer | October 14, 2013 | December 31, 2025 |
| NCT02257736 | Active, not recruiting | Phase 3 | 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) | November 26, 2014 | December 31, 2025 |
| NCT02366494 | Active, not recruiting | Micro RNAs to Predict Response to Androgen Deprivation Therapy | April 29, 2015 | June 2025 | |
| NCT02489318 | Active, not recruiting | Phase 3 | A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC | November 27, 2015 | September 5, 2024 |
| NCT02531516 | Active, not recruiting | Phase 3 | An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS | November 19, 2015 | December 29, 2028 |
| NCT02703623 | Active, not recruiting | Phase 2 | Abiraterone Acetate, Prednisone, and Apalutamide With or Without Ipilimumab or Cabazitaxel and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer | May 18, 2016 | March 31, 2026 |
| NCT02903368 | Active, not recruiting | Phase 2 | Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy | October 19, 2016 | June 2024 |
| NCT02913196 | Active, not recruiting | Phase 1 | Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With mCRPC | December 30, 2016 | October 2025 |
| NCT03009981 | Active, not recruiting | Phase 3 | A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer | March 6, 2017 | January 1, 2025 |
| NCT03141671 | Active, not recruiting | Phase 2 | Randomized Phase II Study of Salvage XRT + ADT +/- Abiraterone and Apalutamide for Rising PSA After RP (FORMULA-509) | November 24, 2017 | December 31, 2025 |
| NCT03360721 | Active, not recruiting | Phase 2 | Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer | March 6, 2018 | April 30, 2025 |
| NCT03371719 | Active, not recruiting | Phase 2 | BIOMARKER TRIAL of APALUTAMIDE and RADIATION for RECURRENT PROSTATE CANCER | April 27, 2018 | October 31, 2028 |
| NCT03412396 | Active, not recruiting | Phase 2 | Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy | March 22, 2018 | July 30, 2024 |
| NCT03436654 | Active, not recruiting | Phase 2 | Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma | June 21, 2018 | February 14, 2025 |
| NCT03503344 | Active, not recruiting | Phase 2 | Apalutamide With or Without Stereotactic Body Radiation in Treating Castration-Resistant Prostate Cancer | December 17, 2019 | January 31, 2027 |
| NCT03523442 | Active, not recruiting | Phase 1 | A Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Participants With Metastatic Castration-Resistant Prostate Cancer | August 31, 2018 | June 30, 2024 |
| NCT03767244 | Active, not recruiting | Phase 3 | A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy | June 11, 2019 | July 19, 2029 |
| NCT03821792 | Active, not recruiting | Phase 2 | Abiraterone Acetate, Prednisone, and Apalutamide in Treating Patients With Hormone-Naive Metastatic Prostate Cancer | July 22, 2019 | October 1, 2024 |
| NCT03902951 | Active, not recruiting | Phase 2 | Antiandrogen Therapy and SBRT in Treating Patients With Recurrent, Metastatic Prostate Cancer | March 17, 2021 | January 1, 2026 |
| NCT04034095 | Active, not recruiting | A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan | July 8, 2019 | October 8, 2025 | |
| NCT04108208 | Active, not recruiting | Phase 4 | A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Prostate Cancer (NM-CRPC) | December 17, 2019 | June 5, 2026 |
| NCT04267887 | Active, not recruiting | Phase 2 | Advanced ChemoHormonal Therapy for Treatment Naive Metastatic Prostate Cancer | May 11, 2020 | January 1, 2030 |
| NCT04325828 | Active, not recruiting | Phase 2 | A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma | April 7, 2020 | September 30, 2025 |
| NCT04666129 | Active, not recruiting | Phase 1 | Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer | February 18, 2021 | May 29, 2024 |
| NCT04926181 | Active, not recruiting | Phase 2 | Apalutamide Plus Cetrelimab in Patients With Treatment-Emergent Small Cell Neuroendocrine Prostate Cancer | March 16, 2022 | February 28, 2025 |
| NCT05202301 | Active, not recruiting | A Study Using Available Data to Learn to What Extent Patients With Prostate Cancer Who Received Second Generation Androgen Receptor Inhibitors Took Their Medication as Prescribed or Stopped Taking Their Medication Completely | January 15, 2022 | June 30, 2024 | |
| NCT06013475 | Active, not recruiting | An Observational Cohort Study to Describe and Compare the Use of Darolutamide, Enzalutamide and Apalutamide and How Well These Work in Men With Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) in Real World Settings | August 31, 2023 | August 31, 2024 | |
| NCT03311555 | Completed | Phase 2 | A Salvage Trial of AR Inhibition With ADT and Apalutamide With Radiation Therapy Followed by Docetaxel in Men With PSA Recurrent Prostate Cancer After Radical Prostatectomy (STARTAR) | March 28, 2018 | December 22, 2022 |
| NCT04523207 | Completed | Phase 2 | A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases | August 19, 2020 | October 25, 2023 |
| NCT06204302 | Completed | An Observational Study to Learn More About the Use of Androgen Receptor Inhibitors and How They Affect Men With Nonmetastatic Prostate Cancer in Routine Medical Care in the United States | January 5, 2024 | April 4, 2024 | |
| NCT05701007 | Completed | Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland | February 13, 2023 | April 10, 2024 | |
| NCT03365297 | Completed | Phase 2 | Therapeutics in Active Prostate Cancer Surveillance | June 5, 2018 | July 25, 2019 |
| NCT03298087 | Completed | Phase 2 | Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer | July 1, 2018 | March 31, 2024 |
| NCT03279250 | Completed | Phase 2 | Apalutamide and Gonadotropin-Releasing Hormone Analog With or Without Abiraterone Acetate in Treating Participants With Prostate Cancer | October 13, 2017 | May 11, 2021 |
| NCT02106507 | Completed | Phase 1 | ARN 509 Plus Everolimus in Men With Progressive Metastatic Castration-Resistant Prostate Cancer After Treatment With Abiraterone Acetate | April 2014 | June 28, 2021 |
| NCT03124433 | Completed | Phase 2 | Neoadjuvant Apalutamide (ARN509) and Radical Prostatectomy in Treatment of Intermediate to High Risk Prostate Cancer | June 20, 2017 | August 22, 2019 |
| NCT02924766 | Completed | Phase 1 | A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE) | October 3, 2016 | July 19, 2019 |
| NCT05362149 | Completed | An Observational Study, Called DEAR, to Learn More About Treatment With Darolutamide, Enzalutamide and Apalutamide in Men With Non-metastatic Castration-resistant Prostate Cancer in Real World Settings | April 4, 2022 | June 30, 2023 | |
| NCT03802682 | Completed | Phase 1 | A Study of Apalutamide Administered Orally as Whole Tablets and as a Mixture in Applesauce in Healthy Participants | January 11, 2019 | April 11, 2019 |
| NCT02867020 | Completed | Phase 2 | Study of Abiraterone Acetate Plus ADT Versus APALUTAMIDE Versus Abiraterone and APALUTAMIDE in Patients With Advanced Prostate Cancer With Non-castrate Testosterone Levels | October 11, 2017 | June 30, 2021 |
| NCT02849990 | Completed | Phase 2 | A Phase II Neoadjuvant Study of Apalutamide, Abiraterone Acetate, Prednisone, Degarelix and Indomethacin in Men With Localized Prostate Cancer Pre-prostatectomy | March 9, 2017 | December 10, 2020 |
| NCT02789878 | Completed | Phase 2 | Neoadjuvant Androgen Deprivation Therapy Plus Abiraterone With or Without Apalutamide for High-Risk Prostate Cancer | January 24, 2019 | August 1, 2022 |
| NCT02770391 | Completed | Phase 2 | Apalutamide and Leuprolide in Intermediate and High-risk Prostate Cancer | October 17, 2016 | April 29, 2020 |
| NCT02578797 | Completed | Phase 1 | A JNJ-56021927 (ARN-509; Apalutamide) QT/QTc Study | December 18, 2015 | October 13, 2022 |
| NCT03523338 | No longer available | An Expanded Access Protocol for Apalutamide Treatment of Participants With Non-Metastatic Castration-Resistant Prostate Cancer | |||
| NCT05521698 | Not yet recruiting | Phase 1 | Study to Determine Possible Effects of Apalutamide on EGFR Expression in Patients With Non-muscle Invasive Bladder Cancer | June 15, 2024 | May 15, 2027 |
| NCT05717582 | Not yet recruiting | Phase 2 | Maximal Cytoreductive Therapies on Post-treatment Metastases in Pts With mHSPC During Apalutamide Plus ADT Treatment | May 1, 2023 | December 31, 2026 |
| NCT06430411 | Not yet recruiting | Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET Study | May 31, 2024 | December 31, 2031 | |
| NCT06274047 | Not yet recruiting | Phase 3 | PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer. | August 31, 2024 | June 30, 2029 |
| NCT06320067 | Not yet recruiting | Phase 3 | A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer | April 2024 | March 2034 |
| NCT05422911 | Not yet recruiting | Phase 2 | Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer. | June 30, 2022 | June 30, 2026 |
| NCT05367440 | Recruiting | Phase 1/Phase 2 | Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer | June 2, 2022 | August 15, 2030 |
| NCT05818683 | Recruiting | Phase 1 | A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Castration-Resistant Prostate Cancer | April 26, 2023 | September 1, 2027 |
| NCT05406999 | Recruiting | Phase 2 | Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer | February 1, 2020 | June 30, 2030 |
| NCT05751941 | Recruiting | Phase 2 | Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer | February 14, 2023 | October 2025 |
| NCT04530552 | Recruiting | Phase 2 | Testing the Effects of Low Dose Apalutamide on Prostate-Specific Antigen (PSA) Levels in Men Scheduled for Removal of the Prostate Gland | July 23, 2021 | January 31, 2027 |
| NCT04557059 | Recruiting | Phase 3 | A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer | November 12, 2020 | August 27, 2029 |
| NCT04421222 | Recruiting | Phase 1 | Oral EPI-7386 in Patients With Castration-Resistant Prostate Cancer | June 23, 2020 | September 2026 |
| NCT04601441 | Recruiting | Phase 4 | Study to Evaluate ctDNA of mCSPC Patients Receiving Apalutamide in Japan | November 6, 2020 | March 31, 2025 |
| NCT05740488 | Recruiting | N/A | Efficacy and Safety of Apalutamide in Combination With 89Sr as Neoadjuvant Therapy in Prostate Cancer With ≤10 Bone Metastases | January 7, 2022 | December 2025 |
| NCT04181203 | Recruiting | Phase 3 | Combined Apalutamide, Radiotherapy, and LHRH Agonist in Prostate Cancer Patients After Prostatectomy | January 9, 2020 | December 28, 2033 |
| NCT04947254 | Recruiting | Phase 2 | Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer | August 5, 2021 | June 7, 2026 |
| NCT04134260 | Recruiting | Phase 3 | Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer | March 5, 2020 | November 1, 2026 |
| NCT04997252 | Recruiting | N/A | An Evaluation of the Efficacy and Safety of Apalutamide as Neoadjuvant Endocrine Therapy in High-Risk and Oligometastatic Prostate Cancer | February 1, 2021 | December 2024 |
| NCT05159245 | Recruiting | Phase 2 | The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs | December 10, 2021 | November 25, 2026 |
| NCT06378866 | Recruiting | Phase 2 | Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial | June 3, 2024 | May 31, 2029 |
| NCT05212857 | Recruiting | Phase 2 | Enhanced Systemic Combined With Local Treatment for Primary and Metastatic Lesions in Oligo-metastatic Prostate Cancer | April 2022 | September 2024 |
| NCT05960578 | Recruiting | Phase 2 | Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study | May 6, 2024 | December 31, 2027 |
| NCT04423211 | Recruiting | Phase 3 | Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging | October 8, 2020 | December 31, 2032 |
| NCT04513717 | Recruiting | Phase 3 | Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial | December 15, 2020 | December 31, 2033 |
| NCT03903835 | Recruiting | Phase 3 | ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer | February 1, 2019 | December 2026 |
| NCT05901649 | Recruiting | A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide | July 5, 2023 | September 5, 2025 | |
| NCT06067269 | Recruiting | Phase 2 | Hormone Therapy (Apalutamide) and Image-guided Stereotactic Body Radiation Therapy for the Treatment of Patients With Prostate Cancer, HEATWAVE Trial | March 28, 2024 | December 1, 2027 |
| NCT03899077 | Recruiting | Phase 2 | Radiotherapy Combined With a LHRH (Ant)Agonist Versus Apalutamide in Patients With Biochemical Recurrence After RP | April 5, 2019 | December 2025 |
| NCT05884398 | Recruiting | Phase 3 | A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC | August 31, 2023 | May 31, 2027 |
| NCT04154774 | Recruiting | Phase 1 | A Study of Apalutamide in Participants With Severe Hepatic Impairment Compared With Participants With Normal Hepatic Function | November 7, 2019 | September 24, 2024 |
| NCT05534646 | Recruiting | Phase 2 | Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer | December 27, 2023 | January 2027 |
| NCT04409288 | Terminated | Phase 3 | Patient Preference of Apalutamide Versus Enzalutamide in Patients With Recurrent or Metastatic Hormone-Sensitive Prostate Cancer | July 20, 2020 | October 16, 2023 |
| NCT05295927 | Terminated | Phase 1 | A Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone, or Apalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) | March 23, 2022 | September 30, 2022 |
| NCT02721979 | Terminated | Phase 2 | Apalutamide in Treating Patients With Prostate Cancer Who Are in Active Surveillance | November 2, 2017 | November 30, 2021 |
| NCT03777982 | Terminated | Phase 3 | Conventional ADT w/ or w/Out Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and ADT | April 20, 2020 | February 13, 2024 |
| NCT03093272 | Terminated | Phase 2 | A Study of Docetaxel + ARN-509 in Castration-Resistant Prostate Cancer | June 23, 2017 | December 31, 2019 |
| NCT03088124 | Unknown status | Phase 2 | Active Surveillance With or Without Apalutamide Treatment in Low Risk Prostate Cancer | April 28, 2017 | April 28, 2022 |
| NCT02906605 | Withdrawn | Phase 2 | A Study of the Clinical Activity and Safety of JNJ-64041809, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Apalutamide Versus Apalutamide in Subjects With Metastatic Castration-resistant Prostate Cancer | October 2016 | September 2018 |
| NCT03173859 | Withdrawn | Phase 2 | Efficacy of Rotations Between Abiraterone Acetate and Apalutamide in mCRPC Patients | January 2018 | December 31, 2020 |
| NCT02811809 | Withdrawn | Phase 2 | Apalutamide Plus Intermittent Hormone Therapy Versus Intermittent Hormone Therapy Alone in Prostate Cancer | December 2020 | December 2025 |
| NCT03488810 | Withdrawn | Phase 3 | Apalutamide With Radiotherapy and Androgen Deprivation Therapy in Prostate Cancer | March 10, 2020 | June 15, 2026 |
| NCT04585932 | Withdrawn | Phase 2 | Androgen Deprivation Therapy and Apalutamide With or Without Radiation Therapy for the Treatment of Biochemically Recurrent Prostate Cancer, RESTART Study | November 24, 2020 | January 8, 2021 |