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    DRUG:

    Firmagon (degarelix)

    i
    Other names: FE200486, ASP-3550, ASP3550, uglypeptide-1, FE-200486
    Company:
    Astellas, Ferring
    Drug class:
    GnRH antagonist
    Related drugs:
    13d
    Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer (clinicaltrials.gov)
    P2, N=19, Active, not recruiting, University of Colorado, Denver | Trial completion date: Apr 2024 --> Apr 2025
    Trial completion date
    |
    Xtandi (enzalutamide capsule) • triptorelin • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension
    16d
    ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer (clinicaltrials.gov)
    P3, N=392, Recruiting, NYU Langone Health
    New P3 trial
    |
    Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    24d
    Myeloid-derived suppressor cells attenuate the antitumor efficacy of radiopharmaceutical therapy using 90Y-NM600 in combination with androgen deprivation therapy in murine prostate tumors. (PubMed, J Immunother Cancer)
    The combination of ADT and TRT improved antitumor responses in murine models of prostate cancer, however, this was dependent on the order of administration. This was found to be associated with one treatment sequence leading to an increase in infiltrating MDSCs. Combining treatment with a CXCR2 antagonist improved the antitumor effect of this combination, suggesting a possible approach for treating advanced human prostate cancer.
    Preclinical • Journal • Combination therapy
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • CXCR2 (Chemokine (C-X-C motif) receptor 2) • CXCL1 (Chemokine (C-X-C motif) ligand 1)
    |
    Firmagon (degarelix) • 90Y-NM600 • reparixin (DF 1681Y)
    25d
    NeoADT-TULSA: Neoadjuvant ADT With TULSA in the Treatment of Intermediate Risk Prostate Cancer (clinicaltrials.gov)
    P1, N=15, Recruiting, Turku University Hospital | Not yet recruiting --> Recruiting | Initiation date: Jul 2023 --> Oct 2023 | Trial primary completion date: Jul 2025 --> Dec 2025
    Enrollment open • Trial initiation date • Trial primary completion date
    |
    Firmagon (degarelix)
    26d
    Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors (clinicaltrials.gov)
    P2; Recruiting --> Active, not recruiting
    Combination therapy • Enrollment closed • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRCA1 (Breast cancer 1, early onset) • MSI (Microsatellite instability) • CD8 (cluster of differentiation 8) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • CDK12 (Cyclin dependent kinase 12) • CHEK2 (Checkpoint kinase 2) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin)) • ABRAXAS1 (Abraxas 1 BRCA1 A Complex Subunit 2) • GEN1 (GEN1 Holliday junction 5' flap endonuclease)
    |
    PD-L1 expression • MSI-H/dMMR
    |
    OncoPanel™ Assay
    |
    Opdivo (nivolumab) • docetaxel • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension
    26d
    Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland (clinicaltrials.gov)
    P=N/A, N=1, Completed, Pfizer | Trial completion date: Jun 2023 --> Apr 2024 | Trial primary completion date: Jun 2023 --> Apr 2024
    Trial completion date • Trial primary completion date • HEOR • Real-world evidence • Real-world • Metastases
    |
    docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • cabazitaxel • Erleada (apalutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • Xofigo (radium Ra-223 dichloride) • leuprolide acetate for depot suspension
    27d
    Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, Mayo Clinic
    New P2 trial • Metastases
    |
    Xtandi (enzalutamide capsule) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    1m
    EORTC-1532: ODM-201 vs Androgen Deprivation Therapy in Hormone naïve Prostate Cancer (clinicaltrials.gov)
    P2, N=61, Active, not recruiting, European Organisation for Research and Treatment of Cancer - EORTC | Trial completion date: May 2024 --> Dec 2036
    Trial completion date
    |
    Nubeqa (darolutamide) • triptorelin • goserelin acetate • Firmagon (degarelix)
    1m
    PEGASUS: Trial Comparing Irradiation Plus Long Term Adjuvant Androgen Deprivation With GnRH Antagonist Versus GnRH Agonist Plus Flare Protection in Patients With Very High Risk Localized or Locally Advanced Prostate Cancer (clinicaltrials.gov)
    P3, N=885, Active, not recruiting, European Organisation for Research and Treatment of Cancer - EORTC | Trial completion date: Jun 2024 --> Jun 2026 | Trial primary completion date: Jun 2024 --> Nov 2023
    Trial completion date • Trial primary completion date • Metastases
    |
    Firmagon (degarelix)
    2ms
    NeoAdjuvant Theranostic Lutetium Study: The Nautilus Trial (clinicaltrials.gov)
    P1/2, N=36, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression
    |
    Firmagon (degarelix)
    2ms
    HyBraFi: Toxicity Comparison Between Hypofractionated Radiotherapy With HDR Brachytherapy Boost Versus Standard Treatment (clinicaltrials.gov)
    P=N/A, N=30, Active, not recruiting, CHU de Quebec-Universite Laval | Trial completion date: Jun 2023 --> Jun 2025 | Trial primary completion date: Mar 2023 --> Jun 2024
    Trial completion date • Trial primary completion date
    |
    Firmagon (degarelix)
    2ms
    Ovarian Hormone Regulation of Central and Cerebrovascular Hemodynamics (NoMEN Study) (clinicaltrials.gov)
    P4, N=55, Active, not recruiting, University of Colorado, Denver | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Firmagon (degarelix)
    3ms
    Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in Prostate Cancer (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, M.D. Anderson Cancer Center | Initiation date: Sep 2023 --> Sep 2024
    Trial initiation date • Combination therapy • Metastases
    |
    Talzenna (talazoparib) • Xtandi (enzalutamide capsule) • Firmagon (degarelix)
    3ms
    Androgen Deprivation Therapy Prior to Prostatectomy for Patients With Intermediate and High Risk Prostate Cancer (clinicaltrials.gov)
    P=N/A, N=41, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
    Trial completion date • Trial primary completion date
    |
    CASP3 (Caspase 3)
    |
    Firmagon (degarelix)
    3ms
    Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer (clinicaltrials.gov)
    P1/2, N=93, Active, not recruiting, Praful Ravi, MB BCHir, MRCP | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Verzenio (abemaciclib) • Eligard (leuprolide acetate) • Nubeqa (darolutamide) • goserelin acetate • Firmagon (degarelix)
    3ms
    THUNDER: Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (clinicaltrials.gov)
    P2/3; N=493; Recruiting; Sponsor:Cancer Research Antwerp
    New P2/3 trial
    |
    Decipher Prostate Cancer Test
    |
    docetaxel • Eligard (leuprolide acetate) • Nubeqa (darolutamide) • triptorelin • goserelin acetate • Firmagon (degarelix)
    3ms
    LILAC: Cardiometabolic Consequences of the Loss of Ovarian Function (clinicaltrials.gov)
    P4, N=100, Not yet recruiting, University of Colorado, Denver
    New P4 trial
    |
    Firmagon (degarelix)
    3ms
    SAVE: Radiotherapy Combined With a LHRH (Ant)Agonist Versus Apalutamide in Patients With Biochemical Recurrence After RP (clinicaltrials.gov)
    P2, N=202, Recruiting, Cancer Research Antwerp | Trial completion date: Sep 2022 --> Dec 2025 | Trial primary completion date: Dec 2021 --> Aug 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    Erleada (apalutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension
    3ms
    First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer (clinicaltrials.gov)
    P2, N=31, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Phase classification: P2a --> P2 | Trial completion date: May 2026 --> Jan 2027 | Trial primary completion date: May 2025 --> Jan 2027
    Phase classification • Trial completion date • Trial primary completion date • Metastases
    |
    docetaxel • Tevimbra (tislelizumab) • Xtandi (enzalutamide capsule) • abiraterone acetate • triptorelin • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    3ms
    Addressing the risk and management of cardiometabolic complications in prostate cancer patients on androgen deprivation therapy and androgen receptor axis-targeted therapy: consensus statements from the Hong Kong Urological Association and the Hong Kong Society of Uro-Oncology. (PubMed, Front Oncol)
    The panel reached a consensus on 18 statements based on recent evidence and expert insights. These consensus statements serve as a practical recommendation for clinicians in Hong Kong, and possibly the Asia-Pacific region, in the management of cardiometabolic toxicities of ADT or AR axis-targeted therapies in men with PCa.
    Review • Journal
    |
    AR (Androgen receptor)
    |
    Xtandi (enzalutamide capsule) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide) • Firmagon (degarelix) • leuprolide acetate for depot suspension
    4ms
    Real-life Evaluation of the Effect of ADT in Prostate Cancer Patients in Asia (READT Asia Study) (clinicaltrials.gov)
    P=N/A, N=300, Active, not recruiting, Chinese University of Hong Kong | Recruiting --> Active, not recruiting | N=600 --> 300
    Enrollment closed • Enrollment change
    |
    Eligard (leuprolide acetate) • Firmagon (degarelix)
    4ms
    A Study of Copanlisib in Combination With Degarelix in People With Prostate Cancer (clinicaltrials.gov)
    P1/2, N=37, Recruiting, Memorial Sloan Kettering Cancer Center
    New P1/2 trial • Combination therapy
    |
    Aliqopa (copanlisib) • Firmagon (degarelix)
    4ms
    Phase II Study of Docetaxel Before Degarelix in Patients With Newly Diagnosed Metastatic Prostate Cancer. (clinicaltrials.gov)
    P2, N=52, Active, not recruiting, Medical University of South Carolina | Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Nov 2023 --> Mar 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    docetaxel • Firmagon (degarelix)
    5ms
    Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation (clinicaltrials.gov)
    P2, N=82, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date
    |
    CD34 (CD34 molecule) • CD4 (CD4 Molecule)
    |
    Chr t(15;17)
    |
    cyclophosphamide • Firmagon (degarelix) • thiotepa • leuprolide acetate for depot suspension • Kepivance (palifermin)
    5ms
    Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer (clinicaltrials.gov)
    P2, N=70, Recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Aug 2027 | Trial primary completion date: Dec 2023 --> Aug 2027
    Trial completion date • Trial primary completion date
    |
    Talzenna (talazoparib) • abiraterone acetate • Eligard (leuprolide acetate) • bicalutamide • goserelin acetate • Firmagon (degarelix) • Viadur (leuprorelin implant) • Yonsa (abiraterone acetate)
    5ms
    High-Dose Brachytherapy in Treating Patients With Prostate Cancer (clinicaltrials.gov)
    P=N/A, N=163, Active, not recruiting, Stanford University
    Trial completion date
    |
    bicalutamide • triptorelin • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension
    5ms
    Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8) (clinicaltrials.gov)
    P1/2, N=60, Active, not recruiting, Mark Stein | Phase classification: P1b/2 --> P1/2 | Trial completion date: Dec 2023 --> Jan 2025 | Trial primary completion date: Oct 2023 --> May 2024
    Phase classification • Trial completion date • Trial primary completion date • Combination therapy
    |
    Opdivo (nivolumab) • Firmagon (degarelix) • BMS-986253
    5ms
    Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer (clinicaltrials.gov)
    P1/2, N=60, Recruiting, University of Wisconsin, Madison | N=39 --> 60 | Trial completion date: Apr 2025 --> Dec 2028 | Trial primary completion date: Apr 2025 --> Dec 2026
    Enrollment change • Trial completion date • Trial primary completion date • Checkpoint inhibition • Checkpoint block
    |
    CD8 (cluster of differentiation 8)
    |
    Opdivo (nivolumab) • Libtayo (cemiplimab-rwlc) • Firmagon (degarelix) • fianlimab (REGN3767) • MVI-118
    6ms
    CASPAR: 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 (clinicaltrials.gov)
    P3, N=61, Active, not recruiting, Alliance for Clinical Trials in Oncology | Suspended --> Active, not recruiting | N=1002 --> 61
    Enrollment closed • Enrollment change • Metastases
    |
    HRD (Homologous Recombination Deficiency)
    |
    Xtandi (enzalutamide capsule) • Rubraca (rucaparib) • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension
    6ms
    Radium Ra 223 Dichloride, Hormone Therapy and Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Prostate Cancer (clinicaltrials.gov)
    P2, N=25, Active, not recruiting, City of Hope Medical Center | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Apr 2025 | Trial primary completion date: Dec 2023 --> Apr 2025
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Eligard (leuprolide acetate) • goserelin acetate • Firmagon (degarelix) • Xofigo (radium Ra-223 dichloride) • Viadur (leuprorelin implant)
    6ms
    High-Dose Brachytherapy in Treating Patients With Prostate Cancer (clinicaltrials.gov)
    P=N/A, N=163, Active, not recruiting, Stanford University | Phase classification: P1/2 --> P=N/A
    Phase classification
    |
    bicalutamide • triptorelin • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension
    6ms
    NeoAdjuvant Theranostic Lutetium Study: The Nautilus Trial (clinicaltrials.gov)
    P1/2, N=36, Not yet recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Jun 2026 | Initiation date: Mar 2024 --> Dec 2023 | Trial primary completion date: Dec 2024 --> Jun 2025
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression
    |
    Firmagon (degarelix)
    7ms
    Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland (clinicaltrials.gov)
    P=N/A, N=1, Completed, Pfizer | Recruiting --> Completed | Trial completion date: Nov 2023 --> Jun 2023 | Trial primary completion date: Nov 2023 --> Jun 2023
    Trial completion • Trial completion date • Trial primary completion date • HEOR • Real-world evidence • Real-world • Metastases
    |
    docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • cabazitaxel • Erleada (apalutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • Xofigo (radium Ra-223 dichloride) • leuprolide acetate for depot suspension
    7ms
    Enzalutamide-Induced Acute Maculopapular Rash in Treatment of Metastatic Prostate Cancer: First Case Report from a Tertiary Cancer Care Center of North India. (PubMed, Indian J Surg Oncol)
    Most common among these are apalutamide...He was started on Degarelix subcutaneous injection with oral abiraterone initially...Intramuscular Injection leuprolide was started and initial responses were good followed by later rise of PSA from January...Rather, it should be with stopped for 10-14 days. Basic treatment with anti-histaminics or topical steroids may be enough to warranty the resolution of symptoms, and the drug (Enzalutamide) can be continued thereafter.
    Journal • Metastases
    |
    AR (Androgen receptor)
    |
    Xtandi (enzalutamide capsule) • abiraterone acetate • Erleada (apalutamide) • Firmagon (degarelix) • leuprolide acetate for depot suspension
    7ms
    ETHAN - ET for Male BC (clinicaltrials.gov)
    P2, N=60, Recruiting, Jose Pablo Leone | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    Verzenio (abemaciclib) • anastrozole • Firmagon (degarelix) • Soltamox (tamoxifen citrate)
    7ms
    Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=50, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Xtandi (enzalutamide capsule) • Eligard (leuprolide acetate) • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix)
    8ms
    TASUC-Neo: Targeting Androgen Signaling in Urothelial Cell Carcinoma - Neoadjuvant (clinicaltrials.gov)
    P1, N=32, Recruiting, Brown University | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    AR (Androgen receptor)
    |
    AR positive
    |
    cisplatin • gemcitabine • Firmagon (degarelix)
    8ms
    NeoAdjuvant Theranostic Lutetium Study: The Nautilus Trial (clinicaltrials.gov)
    P1/2, N=30, Not yet recruiting, M.D. Anderson Cancer Center
    New P1/2 trial
    |
    FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression
    |
    Firmagon (degarelix)
    8ms
    Neoadjuvant Phase 2 Study Comparing the Effects of AR Inhibition With/Without SRC or MEK Inhibition in Prostate Cancer (clinicaltrials.gov)
    P2, N=45, Active, not recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2023 --> Sep 2024
    Trial completion date • Trial primary completion date
    |
    VIM (Vimentin) • CDH2 (Cadherin 2)
    |
    VIM expression
    |
    Mekinist (trametinib) • dasatinib • Xtandi (enzalutamide capsule) • Firmagon (degarelix)
    10ms
    Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors (clinicaltrials.gov)
    P2; Trial primary completion date: Jun 2023 --> Jun 2024
    Combination therapy • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRCA1 (Breast cancer 1, early onset) • MSI (Microsatellite instability) • CD8 (cluster of differentiation 8) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • CDK12 (Cyclin dependent kinase 12) • CHEK2 (Checkpoint kinase 2) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin)) • ABRAXAS1 (Abraxas 1 BRCA1 A Complex Subunit 2) • GEN1 (GEN1 Holliday junction 5' flap endonuclease)
    |
    PD-L1 expression • MSI-H/dMMR
    |
    OncoPanel™ Assay
    |
    Opdivo (nivolumab) • docetaxel • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension
    10ms
    Heterogeneity in regional changes in body composition induced by androgen deprivation therapy in prostate cancer patients: potential impact on bone health-the BLADE study. (PubMed, J Endocrinol Invest)
    an heterogeneous change in body composition among body district is observed after ADT and bone turnover is influenced by lean mass and its variation. A supervised physical activity is crucial to maintain general physical performance and preserving bone health.
    Journal
    |
    Firmagon (degarelix)
    11ms
    A multicenter, retrospective observational study investigating baseline characteristics and clinical outcomes in patients with hormone-sensitive prostate cancer treated with primary androgen deprivation therapy. (PubMed, Jpn J Clin Oncol)
    This study clarified patient characteristics and long-term effectiveness of primary androgen deprivation therapy in real-world clinical practice. Japanese urologists appear to select appropriate primary androgen deprivation therapy based on patient background and tumour characteristics, with degarelix largely reserved for higher risk patients.
    Clinical data • Observational data • Retrospective data • Journal
    |
    goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension