^
    6d
    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)
    7d
    A Study to Evaluate the Drug Levels, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants (clinicaltrials.gov)
    P1, N=24, Recruiting, Celgene | Trial completion date: Sep 2024 --> Feb 2025 | Trial primary completion date: Sep 2024 --> Feb 2025
    Trial completion date • Trial primary completion date
    13d
    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)
    15d
    A Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC). (clinicaltrials.gov)
    P3, N=417, Recruiting, Hinova Pharmaceuticals Inc. | N=255 --> 417 | Trial primary completion date: Jun 2024 --> Dec 2024
    Enrollment change • Trial primary completion date • Metastases
    |
    docetaxel • abiraterone acetate • deutenzalutamide (HC-1119)
    20d
    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)
    20d
    Discovery of 5-Nitro-N-(3-(trifluoromethyl)phenyl) Pyridin-2-amine as a Novel Pure Androgen Receptor Antagonist against Antiandrogen Resistance. (PubMed, J Med Chem)
    Therein, EF2 demonstrated potent inhibition of the AR pathway and effectively suppressed tumor growth in a C4-2B xenograft mouse model following oral administration. Further molecular dynamics simulation and mutagenesis studies revealed atomic insights into the mode of action of EF2 which may serve as a novel lead compound for developing therapeutics against AR-driven PCa.
    Journal
    |
    AR (Androgen receptor)
    |
    AR mutation
    24d
    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
    30d
    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
    EPI-7386-CS-010: EPI-7386 in Combination with Enzalutamide Compared with Enzalutamide Alone in Subjects with MCRPC (clinicaltrials.gov)
    P1/2, N=150, Active, not recruiting, ESSA Pharmaceuticals | Recruiting --> Active, not recruiting | Trial completion date: Jan 2026 --> Jan 2025 | Trial primary completion date: Aug 2025 --> Oct 2024
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Xtandi (enzalutamide) • masofaniten (EPI-7386)
    1m
    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)
    1m
    A Study of Bicalutamide With Brain Re-irradiation to Treat Recurrent/Progressive High Grade Glioma (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, University of Nebraska | Initiation date: Oct 2024 --> Jan 2025
    Trial initiation date
    |
    bicalutamide
    1m
    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)
    1m
    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
    CC-94676-PCA-001: Study to Evaluate the Safety and Tolerability of CC-94676 in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=250, Active, not recruiting, Celgene | Recruiting --> Active, not recruiting
    Enrollment closed
    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
    A Study to Assess Sebaceous Gland Changes and Constituents of Sebum (Skin Oil) Induced by Clascoterone 1% Cream in Acne Patients (clinicaltrials.gov)
    P4, N=10, Active, not recruiting, Sun Pharmaceutical Industries Limited | Not yet recruiting --> Active, not recruiting | Trial completion date: Sep 2024 --> Dec 2024 | Trial primary completion date: Sep 2024 --> Dec 2024
    Enrollment closed • Trial completion date • Trial primary completion date
    2ms
    Topical Anti-Androgens in Pilonidal Sinus Disease (clinicaltrials.gov)
    P2, N=75, Not yet recruiting, University of Pennsylvania | Initiation date: Aug 2024 --> Nov 2024
    Trial initiation date
    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
    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
    A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Duac Gel (Benzoyl Peroxide/Clindamycin) for the Treatment of Acne (clinicaltrials.gov)
    P4, N=10, Completed, Sun Pharmaceutical Industries Limited | Active, not recruiting --> Completed
    Trial completion
    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
    Giant Intracranial Meningiomas Requiring Surgery in 2 Transgender Women Treated With Cyproterone Acetate. (PubMed, JCEM Case Rep)
    Our cases highlight the real-world risk of this likely underreported adverse effect and underscore the importance of clinician vigilance for neurological sequelae. We suggest using the lowest dose of CPA that maintains adequate androgen suppression, with consideration of alternative anti-androgens where appropriate.
    Journal • Surgery
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    cyproterone acetate
    2ms
    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
    2ms
    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)
    2ms
    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)
    2ms
    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
    Phase 2/3 Study of KX-826 Solution in Chinese Male Patients With Androgenetic Alopecia (clinicaltrials.gov)
    P2/3, N=756, Not yet recruiting, Suzhou Kintor Pharmaceutical Inc,
    New P2/3 trial
    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
    A Study to Evaluate the Drug Levels, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants (clinicaltrials.gov)
    P1, N=24, Recruiting, Celgene | Not yet recruiting --> Recruiting
    Enrollment open
    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
    TET3 is expressed in prostate cancer tumor-associated macrophages and is associated with anti-androgen resistance. (PubMed, Clin Transl Oncol)
    The efficacy of ADT in prostate cancer is related to the expression of TET3 in TAMs, and TET3 may be a potential therapeutic target for coordinating ADT.
    Journal
    |
    TET3 (Tet Methylcytosine Dioxygenase 3)
    |
    Tafinlar (dabrafenib) • paclitaxel • docetaxel • cyclophosphamide • vincristine • bicalutamide
    4ms
    SCALP1: A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (clinicaltrials.gov)
    P3, N=726, Recruiting, Cassiopea SpA | Trial completion date: Jan 2025 --> Apr 2025 | Trial primary completion date: Jun 2024 --> Oct 2024
    Trial completion date • Trial primary completion date
    4ms
    HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov)
    P3, N=104, Terminated, Hinova Pharmaceuticals USA, Inc. | Trial completion date: Dec 2024 --> Jun 2024 | Active, not recruiting --> Terminated; Terminated by Sponsor for various factors including prolonged duration and enrollment challenges
    Trial completion date • Trial termination • Head-to-Head • Metastases
    |
    Xtandi (enzalutamide) • deutenzalutamide (HC-1119)
    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)