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    DRUG:

    Erleada (apalutamide)

    i
    Other names: JNJ-56021927, ARN-509, ARN509, JNJ 56021927, JNJ927, JNJ 927, ARN 509, JNJ56021927, JNJ-927
    Company:
    J&J
    Drug class:
    Androgen receptor antagonist
    Related drugs:
    8d
    GETUG-AFU 42: Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders) (clinicaltrials.gov)
    P3, N=500, Recruiting, UNICANCER | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • prednisone • Nubeqa (darolutamide) • Erleada (apalutamide) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    12d
    Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer (clinicaltrials.gov)
    P2, N=25, Recruiting, H. Lee Moffitt Cancer Center and Research Institute
    New P2 trial • Metastases
    |
    docetaxel • Xtandi (enzalutamide) • Nubeqa (darolutamide) • Erleada (apalutamide) • triptorelin • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    15d
    Physical Function During ARSI Treatment (clinicaltrials.gov)
    P=N/A, N=24, Completed, UNC Lineberger Comprehensive Cancer Center | Recruiting --> Completed
    Trial completion • Metastases
    |
    Xtandi (enzalutamide) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide)
    23d
    LIBERTAS: A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC (clinicaltrials.gov)
    P3, N=420, Recruiting, Janssen Research & Development, LLC | Trial completion date: Jan 2027 --> Apr 2027
    Trial completion date • Metastases
    |
    Erleada (apalutamide)
    24d
    A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (clinicaltrials.gov)
    P=N/A, N=2903, Active, not recruiting, Pfizer | Completed --> Active, not recruiting | N=1800 --> 2903 | Trial completion date: Feb 2024 --> Jan 2025 | Trial primary completion date: Feb 2024 --> Jan 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    Xtandi (enzalutamide) • abiraterone acetate • Erleada (apalutamide) • Yonsa (abiraterone acetate)
    29d
    Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma (clinicaltrials.gov)
    P2, N=102, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Feb 2025 --> Feb 2026 | Trial primary completion date: Feb 2025 --> Feb 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    CD4 (CD4 Molecule)
    |
    Oncotype DX Genomic Prostate Score® Assay
    |
    abiraterone acetate • prednisone • Erleada (apalutamide)
    29d
    APEX-01: ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer (clinicaltrials.gov)
    P1, N=352, Recruiting, Ambrx, Inc. | N=262 --> 352 | Trial completion date: Mar 2027 --> Dec 2028 | Trial primary completion date: Dec 2025 --> May 2026
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression
    |
    abiraterone acetate • prednisone • Erleada (apalutamide) • JNJ-95298177
    1m
    A Study to Learn About Novel Hormonal Therapies (NHTs) for Metastatic Castration-sensitive Prostate Cancer (mCSPC) in People Who Were in the Armed Forces (clinicaltrials.gov)
    P=N/A, N=1000, Completed, Pfizer | Active, not recruiting --> Completed | Trial completion date: Oct 2024 --> Apr 2024 | Trial primary completion date: Oct 2024 --> Apr 2024
    Trial completion • Trial completion date • Trial primary completion date • Metastases
    |
    Xtandi (enzalutamide) • abiraterone acetate • Erleada (apalutamide) • Yonsa (abiraterone acetate)
    1m
    Micro RNAs to Predict Response to Androgen Deprivation Therapy (clinicaltrials.gov)
    P=N/A, N=42, Completed, Medical College of Wisconsin | Active, not recruiting --> Completed
    Trial completion
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • bicalutamide • Erleada (apalutamide) • triptorelin • goserelin acetate • leuprolide acetate for depot suspension
    1m
    Leptin levels are associated with coronary artery calcification in patients with advanced prostate cancer. (PubMed, Oncologist)
    Among men with mCRPC, there was a high burden of CHD, and higher leptin levels were associated with coronary atherosclerosis independently of traditional cardiac risk factors.
    Journal • Metastases
    |
    LEP (Leptin)
    |
    abiraterone acetate • prednisone • Erleada (apalutamide)
    1m
    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 (clinicaltrials.gov)
    P=N/A, N=13779, Active, not recruiting, Bayer | Trial completion date: Dec 2024 --> Jul 2025 | Trial primary completion date: Dec 2024 --> Jul 2025
    Trial completion date • Trial primary completion date • Adherence
    |
    Xtandi (enzalutamide) • Nubeqa (darolutamide) • Erleada (apalutamide)
    2ms
    EPI-7386-CS-001: Oral EPI-7386 in Patients with Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=99, Active, not recruiting, ESSA Pharmaceuticals | Recruiting --> Active, not recruiting | Trial completion date: Sep 2026 --> Jan 2025 | Trial primary completion date: Apr 2026 --> Oct 2024
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    abiraterone acetate • Erleada (apalutamide) • masofaniten (EPI-7386)
    2ms
    Study of Relugolix in Men with Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=48, Completed, Sumitomo Pharma Switzerland GmbH | Active, not recruiting --> Completed | N=72 --> 48 | Trial completion date: May 2025 --> May 2024 | Trial primary completion date: May 2025 --> May 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    docetaxel • abiraterone acetate • prednisone • Erleada (apalutamide) • Orgovyx (relugolix) • Yonsa (abiraterone acetate)
    2ms
    Testing the Effects of Low Dose Apalutamide on Prostate-Specific Antigen (PSA) Levels in Men Scheduled for Removal of the Prostate Gland (clinicaltrials.gov)
    P2, N=40, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • NCAM1 (Neural cell adhesion molecule 1)
    |
    NCAM1 positive
    |
    Erleada (apalutamide)
    2ms
    Efficacy and Predictive Factors Analysis of Androgen Deprivation Plus Novel Hormone Therapy as Neoadjuvant Treatment for High-Risk Prostate Cancer. (PubMed, Prostate)
    Herein, we demonstrated the superior performance of ADT plus apalutamide in achieving pCR or MRD and in extending BCR duration among HRPC patients. Post-intervention pre-RP PSA content as well as genetic shifts, especially in the AR axis, are critical indicators of patient pathological and clinical outcomes. These findings highlight the significance of genetic testing and PSA content monitoring in treating HRPC patients.
    Journal
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    abiraterone acetate • Erleada (apalutamide)
    2ms
    Tumor regression after neoadjuvant hormonal therapy in high risk prostate cancer: pathological outcomes from a randomized phase II trial. (PubMed, World J Urol)
    There are subgroups of patients, such as those with low baseline cancer burden and PTEN/ERG wild-type status, more likely to achieve good response with nADT. In the case of long term oncological benefit to be proven, nADT might be an additional therapeutic resource for these patients.
    Clinical • P2 data • Journal
    |
    PTEN (Phosphatase and tensin homolog)
    |
    abiraterone acetate • prednisone • Erleada (apalutamide) • goserelin acetate
    2ms
    Ultralow Prostate-Specific Antigen (PSA) Levels and Improved Oncological Outcomes in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Patients Treated with Apalutamide: A Real-World Multicentre Study. (PubMed, J Clin Med)
    For rPFS, only ultralow PSA levels had a significant impact (HR = 0.085). This real-world study of mHSPC patients treated with Apalutamide plus ADT revealed that achieving ultralow PSA levels is strongly associated with better oncological outcomes.
    Journal • Real-world evidence • Real-world • Metastases
    |
    AR (Androgen receptor)
    |
    Erleada (apalutamide)
    2ms
    PSA-DEEP02: PSA Biochemical Response as Prognostic Factor in Metastatic Castration-Sensitive Prostate Cancer (clinicaltrials.gov)
    P=N/A, N=152, Not yet recruiting, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    New trial • Metastases
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • prednisone • Nubeqa (darolutamide) • Erleada (apalutamide)
    2ms
    TITAN: A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC (clinicaltrials.gov)
    P3, N=1052, Active, not recruiting, Aragon Pharmaceuticals, Inc. | Trial completion date: Sep 2025 --> Dec 2027
    Trial completion date • Metastases
    |
    Erleada (apalutamide)
    2ms
    ACIS: 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) (clinicaltrials.gov)
    P3, N=982, Active, not recruiting, Aragon Pharmaceuticals, Inc. | Trial completion date: Dec 2025 --> Dec 2027
    Trial completion date • Combination therapy • Metastases
    |
    abiraterone acetate • prednisone • Erleada (apalutamide)
    2ms
    SPARTAN: A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P3, N=1207, Active, not recruiting, Aragon Pharmaceuticals, Inc. | Trial completion date: Dec 2025 --> Dec 2027
    Trial completion date • Metastases
    |
    Erleada (apalutamide)
    2ms
    Optimal timing for initiating androgen receptor signaling inhibitor therapy in patients with nonmetastatic castration-resistant prostate cancer: a multicenter collaborative study. (PubMed, Jpn J Clin Oncol)
    Patients with rapid PSADT are at increased risk of early disease progression, suggesting that immediate treatment may be warranted. In addition, initiating therapy at a PSA level <5.4 ng/ml may be associated with improved patient outcomes in patients with low PSADT.
    Journal • Metastases
    |
    ARSI (Arylsulfatase Family Member I)
    |
    Xtandi (enzalutamide) • Nubeqa (darolutamide) • Erleada (apalutamide)
    2ms
    Androgen receptor pathway inhibitors and drug-drug interactions in prostate cancer. (PubMed, ESMO Open)
    These interactions, particularly through pathways like CYP2D6 inhibition by abiraterone and CYP3A4 induction by enzalutamide and apalutamide, necessitate a thorough understanding to optimize therapeutic outcomes and minimize adverse effects. This review aims to delineate the efficacy of ARPIs in prostate cancer management and elucidate their interaction with common medications, highlighting the importance of vigilant drug management to optimize patient care.
    Review • Journal
    |
    CYP3A4 (Cytochrome P450, family 3, subfamily A, polypeptide 4)
    |
    Xtandi (enzalutamide) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide)
    2ms
    YATAGARASU: A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma (clinicaltrials.gov)
    P2, N=31, Active, not recruiting, Janssen Pharmaceutical K.K. | Trial completion date: Sep 2025 --> Dec 2027
    Trial completion date • Combination therapy • Metastases
    |
    AR (Androgen receptor)
    |
    AR positive • AR expression
    |
    Erleada (apalutamide) • goserelin acetate
    2ms
    Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 (Apalutamide) in Castration-Resistant Prostate Cancer (CRPC) (clinicaltrials.gov)
    P1/2, N=127, Active, not recruiting, Aragon Pharmaceuticals, Inc. | Trial completion date: Dec 2024 --> Dec 2027
    Trial completion date • Metastases
    |
    abiraterone acetate • Erleada (apalutamide)
    2ms
    Physical Function During ARSI Treatment (clinicaltrials.gov)
    P=N/A, N=24, Recruiting, UNC Lineberger Comprehensive Cancer Center | Active, not recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Xtandi (enzalutamide) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide)
    2ms
    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 (clinicaltrials.gov)
    P=N/A, N=13779, Active, not recruiting, Bayer | Trial completion date: Sep 2024 --> Dec 2024 | Trial primary completion date: Sep 2024 --> Dec 2024
    Trial completion date • Trial primary completion date • Adherence
    |
    Xtandi (enzalutamide) • Nubeqa (darolutamide) • Erleada (apalutamide)
    3ms
    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 (clinicaltrials.gov)
    P1, N=200, Recruiting, Janssen Research & Development, LLC | N=345 --> 200
    Enrollment change
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • prednisone • Nubeqa (darolutamide) • cabazitaxel • Erleada (apalutamide) • cetrelimab (JNJ-63723283) • JNJ-8343
    3ms
    A Study to Evaluate the Effect of Multiple Doses of JNJ-56021927 on the Pharmacokinetics of Multiple Cytochrome P450 and Transporter Substrates in Participants With Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=20, Recruiting, Aragon Pharmaceuticals, Inc. | Trial completion date: Dec 2024 --> Dec 2027
    Trial completion date
    |
    Erleada (apalutamide) • midazolam hydrochloride
    3ms
    A Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=19, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Jun 2025 --> Dec 2025
    Trial completion date • Metastases
    |
    Erleada (apalutamide)
    3ms
    ArtemisPRO: A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide (clinicaltrials.gov)
    P=N/A, N=450, Recruiting, Janssen-Cilag Ltd. | Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Dec 2025 --> Jun 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    Xtandi (enzalutamide) • Erleada (apalutamide)
    3ms
    A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=57, Active, not recruiting, Aragon Pharmaceuticals, Inc. | Trial completion date: Dec 2024 --> Dec 2027
    Trial completion date • Metastases
    |
    abiraterone acetate • prednisone • Erleada (apalutamide)
    3ms
    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. (clinicaltrials.gov)
    P3, N=120, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Erleada (apalutamide)
    3ms
    Abiraterone Acetate, Prednisone, and Apalutamide in Treating Patients With Hormone-Naive Metastatic Prostate Cancer (clinicaltrials.gov)
    P2, N=60, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Oct 2024 --> Oct 2026 | Trial primary completion date: Oct 2024 --> Oct 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    abiraterone acetate • Erleada (apalutamide) • Yonsa (abiraterone acetate)
    3ms
    ORIC-944-01: Study of ORIC-944 in Patients with Metastatic Prostate Cancer (clinicaltrials.gov)
    P1, N=250, Recruiting, ORIC Pharmaceuticals | N=42 --> 250 | Trial completion date: Jun 2024 --> Sep 2026 | Trial primary completion date: May 2023 --> Dec 2024
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide) • ORIC-944
    3ms
    Study of Relugolix in Men with Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=72, Active, not recruiting, Sumitomo Pharma Switzerland GmbH | Trial completion date: May 2024 --> May 2025 | Trial primary completion date: May 2024 --> May 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    docetaxel • abiraterone acetate • prednisone • Erleada (apalutamide) • Orgovyx (relugolix) • Yonsa (abiraterone acetate)
    3ms
    A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan (clinicaltrials.gov)
    P=N/A, N=979, Completed, Janssen Pharmaceutical K.K. | Active, not recruiting --> Completed | Trial completion date: Oct 2025 --> Aug 2024
    Trial completion • Trial completion date • Metastases
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • bicalutamide • Erleada (apalutamide) • goserelin acetate
    3ms
    TRIPLE-SWITCH: Docetaxel to Androgen Receptor Pathway Inhibitors in Metastatic Castration Sensitive Prostate Cancer Without Deep PSA Response (clinicaltrials.gov)
    P3, N=830, Not yet recruiting, Canadian Cancer Trials Group
    New P3 trial • Metastases
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide)
    4ms
    A case of double-negative prostate cancer with BRCA2 mutation and high tumor mutation burden treated sequentially with olaparib and pembrolizumab. (PubMed, IJU Case Rep)
    An 85-year-old patient with metastatic castration-resistant prostate cancer without prostate-specific antigen progression presented with local recurrence and liver and lung metastases 6 months after orchiectomy and apalutamide. Olaparib and pembrolizumab were administered sequentially, and the patient responded to each treatment for 5 months until radiographic progression. Sequential use of olaparib and pembrolizumab may be effective for double-negative prostate cancer with BRCA2 mutations and high tumor mutation burden.
    Journal • Tumor mutational burden • PD(L)-1 Biomarker • PARP Biomarker • BRCA Biomarker
    |
    TMB (Tumor Mutational Burden) • BRCA2 (Breast cancer 2, early onset) • AR (Androgen receptor)
    |
    BRCA2 mutation • TMB-H
    |
    FoundationOne® CDx
    |
    Keytruda (pembrolizumab) • Lynparza (olaparib) • Erleada (apalutamide)
    4ms
    Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer (clinicaltrials.gov)
    P2, N=26, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Oct 2025 --> Oct 2024
    Trial primary completion date • Metastases
    |
    Xtandi (enzalutamide) • abiraterone acetate • Erleada (apalutamide) • Provenge (sipuleucel-T)
    4ms
    Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression (clinicaltrials.gov)
    P1, N=15, Recruiting, Beth Israel Deaconess Medical Center | Trial completion date: Feb 2025 --> Feb 2026 | Trial primary completion date: Sep 2024 --> Sep 2025
    Trial completion date • Trial primary completion date
    |
    Xtandi (enzalutamide) • Nubeqa (darolutamide) • Erleada (apalutamide)
    5ms
    LIBERTAS: A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC (clinicaltrials.gov)
    P3, N=333, Recruiting, Janssen Research & Development, LLC | Trial completion date: May 2027 --> Jan 2027 | Trial primary completion date: May 2027 --> Jan 2027
    Trial completion date • Trial primary completion date • Metastases
    |
    Erleada (apalutamide)