Firmagon (degarelix) / Astellas, Ferring - LARVOL DELTA

Intensification of androgen deprivation therapy (ADT) in metastatic hormone sensitive prostate cancer (mHSPC): Patterns of use and impact on outcomes from a large academic medical center. (ASCO 2025) - "Funded by No funding sources reported Background: ADT intensification with docetaxel and/or androgen receptor pathway inhibitors (ARPIs) has survival benefit in mHSPC...Leuprolide (85.3%), relugolix (12.1%) or degarelix (2.7%) were used for ADT. Of those who RI, 80.3% received an ARPI; 62.3% received abiraterone, 14.6% darolutamide, 13.9% apalutamide, and 9.3% enzalutamide... While PFS was longer for those who RI, these pts also had higher volume of disease, higher PSA, and higher rates of de novo disease, likely contributing to poorer OS. Even at a large academic institution, only about half of pts received intensification. Pts not given intensification were older, and patient preference was the most commonly identified reason for not receiving intensification."

Metastases • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Patients' Preferences and the Time to Finish Gonadotropin-Releasing Hormone (GnRH) Agonist and Antagonist Injections in Japanese Prostate Cancer Patients. (PubMed, Cureus) - "Results showed that injections of degarelix took significantly longer time to injection than other treatments...One limitation of this study is that the method of leuprorelin administration in Japan (subcutaneous injection) differs from that in other countries (intramuscular injection). Conclusion In summary, the six-month leuprorelin 22.5 mg regimen reduces hospital time. Patient burden was also considered a factor in the selection of GnRH preparations."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Cambridge Neoadjuvant Cancer of the Prostate (CANCAP03): A Window Study into the Effects of Olaparib ± Degarelix in Primary Prostate Cancer. (PubMed, Clin Cancer Res) - "We observed a shared phenotypic response to combination therapy across prostate cancers without known HR repair gene alterations. This suggests alternative mechanisms rather than antiandrogen-induced HR deficiency."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Pembrolizumab With Androgen Deprivation Therapy and Radiotherapy for the Treatment of Patients With High Risk Localized Prostate Cancer (clinicaltrials.gov) - P2 | N=32 | Recruiting | Sponsor: OHSU Knight Cancer Institute | Not yet recruiting ➔ Recruiting | Initiation date: Aug 2024 ➔ Apr 2025

Enrollment open • IO biomarker • Trial initiation date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • PD-L1

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=220 | Recruiting | Sponsor: Mayo Clinic | N=120 ➔ 220

Enrollment change • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8) (clinicaltrials.gov) - P1/2 | N=59 | Active, not recruiting | Sponsor: Mark Stein | Trial completion date: Jan 2025 ➔ Jan 2026

Trial completion date • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer (clinicaltrials.gov) - P2 | N=19 | Completed | Sponsor: University of Colorado, Denver | Active, not recruiting ➔ Completed | Trial completion date: Apr 2025 ➔ Jul 2024

Trial completion • Trial completion date • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

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 | Sponsor: Chinese University of Hong Kong | Trial completion date: Dec 2025 ➔ Mar 2026

Trial completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

SHARP: 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 | Sponsor: City of Hope Medical Center | Trial completion date: Apr 2025 ➔ Feb 2026 | Trial primary completion date: Apr 2025 ➔ Feb 2026

Trial completion date • Trial primary completion date • Castration-Sensitive Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Phase II Study of Docetaxel Before Degarelix in Patients With Newly Diagnosed Metastatic Prostate Cancer. (clinicaltrials.gov) - P2 | N=52 | Completed | Sponsor: Medical University of South Carolina | Active, not recruiting ➔ Completed

Trial completion • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

PRIME-CUT: REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer (clinicaltrials.gov) - P2 | N=26 | Active, not recruiting | Sponsor: Mark Stein | N=20 ➔ 26 | Trial primary completion date: Mar 2024 ➔ Nov 2026

Enrollment change • Trial primary completion date • Castration-Sensitive Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

The COSMYC Trial (COmbined Suppression of MYC) (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

New P2 trial • Castration-Resistant Prostate Cancer • CNS Disorders • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Is the estimated tumor reduction between PSMA PET and final pathology more trustworthy than minimal residual disease in patients undergoing neo-adjuvant ADT? A subanalysis of the randomized phase II ARNEO trial (AUA 2025) - "The ARNEO trial is a double-blind, placebo-controlled trial, evaluating the role of neoadjuvant degarelix (DEG) with apalutamide (APA) or matching placebo (PLB) before RP in men with high-risk PCa. In this prospective phase II trial, estimated relative reduction between PSMA PET/CT volume and final pathology (defined as ≥75% TV decrease) does not seem to be an appropriate surrogate endpoint for BCR-free survival."

Clinical • Minimal residual disease • P2 data • Residual disease • Oncology • Prostate Cancer

Comparison of Cardiovascular Events in Patients with Advanced Prostate Cancer treated with Luteinizing Hormone Releasing Hormone Agonists versus Antagonists in the US: An Analysis of the TriNetX Database (AUA 2025) - "INTRODUCTION AND OBJECTIVE: The standard of care for metastatic castrate-sensitive prostate cancer (mCSPCa) is the androgen deprivation therapy (ADT) using LHRH agonists (LHRH-A: leuprolide, goserelin or triptorelin) or LHRH antagonists (LHRH-An: degarelix or relugolix). In a real-world, multi-center cohort, patients receiving LHRH agonists as compared to LHRH antagonists were found to be at 1.38 times higher risk of experiencing a major adverse cardiovascular event and 2.36 times higher risk of stroke. These data support the potential use of LHRH antagonists preferentially in at-risk patients while prospective data is awaited."

Clinical • Metastases • Cardiovascular • Cerebral Hemorrhage • Genito-urinary Cancer • Hematological Disorders • Myocardial Infarction • Oncology • Prostate Cancer • Solid Tumor

Final oncological outcomes of the randomized phase II trial ARNEO: neoadjuvant degarelix with or without apalutamide prior to radical prostatectomy for high-risk prostate cancer (AUA 2025) - "At 3 years follow-up, no statistically significant difference in terms of BCR was observed between patients treated with neoadjuvant DEG+APA or DEG alone. MRD was not associated with improved BCR-free survival. However, ypT2 and SCD disease following neoadjuvant hormonal therapy was highly associated with improved BCR-free survival, suggesting that ypT2 and SCD disease might be used as a surrogate endpoints for improved BCR-free survival in future surgical trials investigating neoadjuvant hormonal therapy."

Clinical • P2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Study of persistence and adherence to ADT in prostate cancer: relugolix, degarelix, and GnRH agonists in the US. (PubMed, Future Oncol) - "This retrospective study evaluates persistence and adherence of relugolix, degarelix, and GnRH agonists (leuprolide, goserelin, triptorelin, histrelin) using data from the IBM MarketScan Research Database (Jan 2017 - Dec 2022). Persistence and adherence rates were higher in metastatic prostate cancer. Findings support relugolix use as an oral treatment due to its favorable persistence and long-term adherence profiles."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Therapeutic potential of GNRHR analogs and SRC/FAK inhibitors to counteract tumor growth and metastasis in breast cancer. (PubMed, Biochim Biophys Acta Mol Basis Dis) - "Treatments targeting the gonadotropin-releasing hormone receptor (GnRHR), such as the agonist leuprorelin (LEU) and antagonist degarelix (DEGA), are used for hormone-dependent tumors. Combining DEGA with PP2 or FAKi enhanced tumor inhibition, improving mice survival. These findings provide valuable insights into the essential regulatory role of gonadotropins in genes involved in tumorigenic processes, highlighting the potential of GnRHR antagonists combined with Src or FAK inhibitors as a promising strategy to develop new drugs that interfere with the ability of breast tumor progression."

Journal • Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor

Two Studies for Patients With Unfavorable Intermediate 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 Higher Gene Risk Score, The Guidance Trial (clinicaltrials.gov) - P3 | N=2050 | Recruiting | Sponsor: NRG Oncology | Trial completion date: Apr 2037 ➔ Nov 2026 | Trial primary completion date: Apr 2032 ➔ Nov 2026

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

RISK OF CARDIOVASCULAR DISEASE FOLLOWING DEGARELIX VERSUS GONADOTROPIN-RELEASING HORMONE (GNRH) AGONISTS IN PATIENTS WITH PROSTATE CANCER: A SYSTEMATIC REVIEW AND META-ANALYSIS - Dang Nguyen (ACC 2025) - "Degarelix demonstrates a lower incidence of major adverse cardiovascular events compared to GnRH agonists, suggesting a potential cardiovascular safety advantage in prostate cancer treatment. Further studies are required to prove the results of our systematic review and meta-analysis."

Retrospective data • Review • Cardiovascular • Congestive Heart Failure • Genito-urinary Cancer • Heart Failure • Hypertension • Myocardial Infarction • Oncology • Prostate Cancer • Solid Tumor

High-Dose Brachytherapy in Treating Patients With Prostate Cancer (clinicaltrials.gov) - P=N/A | N=146 | Active, not recruiting | Sponsor: Stanford University | Trial completion date: Dec 2026 ➔ May 2026

Trial completion date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Exploration of cardiac adverse events associated with relugolix and degarelix: a multi-center pharmacovigilance study based on the FAERS database. (PubMed, Expert Opin Drug Saf) - "There are differences in the types of cardiac adverse events induced by relugolix and degarelix. Clinicians should consider their differences and enhanced electrocardiogram monitoring when prescribing GnRH antagonists to their patients."

Adverse events • Journal • Cardiovascular • Congestive Heart Failure • Genito-urinary Cancer • Heart Failure • Myocardial Infarction • Oncology • Prostate Cancer • Solid Tumor

ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer (clinicaltrials.gov) - P2 | N=392 | Recruiting | Sponsor: NYU Langone Health | Phase classification: P3 ➔ P2 | Trial completion date: Apr 2028 ➔ Apr 2031 | Trial primary completion date: Apr 2028 ➔ Apr 2030

Phase classification • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Ovarian Hormone Regulation of Central and Cerebrovascular Hemodynamics (NoMEN Study) (clinicaltrials.gov) - P4 | N=55 | Active, not recruiting | Sponsor: University of Colorado, Denver | Trial completion date: Sep 2024 ➔ Jul 2025

Trial completion date

TASUC-Neo: Targeting Androgen Signaling in Urothelial Cell Carcinoma - Neoadjuvant (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Brown University | Trial completion date: Jan 2030 ➔ Jan 2032 | Trial primary completion date: Jan 2025 ➔ Jan 2027

Trial completion date • Trial primary completion date • Bladder Cancer • Oncology • Solid Tumor • Urothelial Cancer • AR

Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer (clinicaltrials.gov) - P2 | N=25 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2027 ➔ Jan 2027 | Trial primary completion date: Dec 2027 ➔ Jan 2027

Trial completion date • Trial primary completion date • Castration-Sensitive Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor