Firmagon (degarelix) / Astellas, Ferring - LARVOL DELTA

Neoadjuvant Antiandrogen Therapy With or Without MEK or SRC Inhibition for Unfavorable-risk Prostate Cancer: A Phase 2 Randomized Clinical Trial. (PubMed, Eur Urol Oncol) - "Neoadjuvant SRC or MEK inhibition does not appear to mitigate the EMT response to ADT or influence clinical or pathological outcomes."

Clinical • Journal • P2 data • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • CDH2 • MAP2K1 • MAP2K2 • VIM

Challenges in analyzing real-world evidence: analysis of androgen deprivation therapy use for prostate cancer in the REASSURE study. (PubMed, ESMO Real World Data Digit Oncol) - "Study objectives included patient demographics, clinical characteristics, and ADT treatment duration by treatment received [goserelin or other ADTs (leuprorelin, degarelix, or triptorelin)]. While some patterns of ADT use in REASSURE were consistent with recommendations from clinical practice guidelines, there were also some inconsistencies. Findings from REASSURE highlighted the importance of considering potential differences in health care systems, population coverage, and patient data collection between regions, as well as incorporating data from multiple sources to capture data from more diverse patient populations, thus improving the quality of outputs from real-world studies."

HEOR • Journal • Real-world evidence • Review • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

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 | Sponsor: Alliance for Clinical Trials in Oncology | Trial primary completion date: Mar 2026 ➔ Mar 2027

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

Efficacy and Safety of Radiotherapy Plus Relugolix in Men With Localized or Advanced Prostate Cancer. (PubMed, JAMA Oncol) - "This multicenter post hoc analysis of patients with localized and advanced prostate cancer receiving radiotherapy in 2 randomized clinical trials (a phase 2 trial of relugolix vs degarelix, and a subset of the phase 3 HERO trial of relugolix vs leuprolide acetate) included men who were receiving radiotherapy and short-term (24 weeks) ADT (n = 103) from 2014 to 2015 and men receiving radiotherapy and longer-term (48 weeks) ADT (n = 157) from 2017 to 2019...Patients receiving longer-term ADT received relugolix, 120 mg, orally once daily (360-mg loading dose) or leuprolide acetate injections every 12 weeks for 48 weeks, with up to 90 days of follow-up...The results of these 2 randomized clinical trials suggest that relugolix rapidly achieves sustained castration in patients with localized and advanced prostate cancer receiving radiotherapy. No new safety concerns were identified when relugolix was used with radiotherapy."

Clinical • Journal • Metastases • Atrial Fibrillation • Cardiovascular • Genito-urinary Cancer • Hypertension • Oncology • Pain • Prostate Cancer • Solid Tumor

A Phase I Clinical Trial Evaluating the Safety and Dosing of Relugolix with Novel Hormonal Therapy for the Treatment of Advanced Prostate Cancer. (PubMed, Target Oncol) - P1 | "Combination therapy of relugolix and abiraterone or apalutamide was associated with a favorable safety and tolerability profile consistent with the known profiles of the individual medications. Castration levels of testosterone were maintained after transitioning to relugolix from other ADTs."

Journal • Metastases • P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Initial Results of a Phase 2 Trial of Stereotactic Body Radiation Therapy, Hormone/Androgen Deprivation Therapy and Radium 223 Dichloride for Oligometastatic Castrate Sensitive Prostate Cancer (SHARP) (ASTRO 2024) - P2 | "Materials/ ADT (degarelix [n=4], relugolix [n=2], or leuprolide [n=19]) was administered starting at least 4 weeks prior to SBRT and continued for 36 weeks. Ra-223 combined with SBRT to oligometastases and 36 weeks ADT in mCSPC is well-tolerated and results in favorable OS and PFS compared to historical controls. Longer follow-up is necessary to assess if the early use of Ra-223 delays development of new bone metastases."

Metastases • P2 data • Anemia • Cardiovascular • Gastroenterology • Genito-urinary Cancer • Hematological Disorders • Hepatology • Hypertension • Leukopenia • Metastatic Castration-Resistant Prostate Cancer • Musculoskeletal Diseases • Neutropenia • Oncology • Prostate Cancer • Solid Tumor • CXCL8 • TNFA

Diagnosis of Prostate Cancer via Transanal Endoscopic Ultrasound-Guided Fine-Needle Biopsy in a Patient With Bone Lesions and a Rapid Clinical Response to Enzalutamide Plus Degarelix. (PubMed, Cureus) - "Early histologic confirmation enabled prompt initiation of ARSI-based therapy, resulting in rapid symptomatic and biochemical improvement. EUS-FNB may be considered in selected cases of suspected prostate cancer when alternative biopsy approaches are not feasible."

Journal • Genito-urinary Cancer • Musculoskeletal Pain • Oncology • Pain • Prostate Cancer • Solid Tumor • Urology

Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Xiao X. Wei, MD | Trial completion date: Dec 2025 ➔ Jun 2026

Trial completion date • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • ABRAXAS1 • BRCA1 • BRIP1 • CD8 • CDK12 • CHEK2 • GEN1 • MLH1 • MSH2 • MSH6 • MSI • NBN • PD-L1 • RAD51C • RAD51D

Targeting androgen signaling in urothelial carcinoma (AACR 2024) - P1 | "In a study of 9 men and 1 woman with metastatic UC, all patients were treated with gemcitabine/cisplatin and concurrent enzalutamide...In our study (TASUC; NCT05839119), we add degarelix to standard neoadjuvant chemotherapy to treat men and women who have AR positive UC.The main eligibility criteria are:(1) Muscle-invasive urothelial carcinoma of the bladder (2) AR positive disease by nuclear staining on immunohistochemistry (3) pT2 - T4, N0 - N1, M0 (Stage II or IIIA disease) (4) Eligible for cisplatin-based chemotherapy (5) Eligible for cystectomyIn this single-arm study, all patients receive standard of care gemcitabine/cisplatin neoadjuvant chemotherapy (4 cycles) with the addition of monthly degarelix during chemotherapy...If we observe at least 14 pCRs (of 32 patients) the study will be considered positive and we will plan a follow-up randomized, controlled phase II (or phase III) study.Exploratory outcomes include correlation of AR positivity with..."

Bladder Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer • AR

Clonal selection of pre-existing neuroendocrine component in prostate cancer during androgen receptor signaling inhibitor therapy: A case report. (PubMed, Urol Case Rep) - "A 79-year-old man with metastatic prostate cancer received degarelix plus apalutamide. Liver biopsy revealed PSA-negative, neuroendocrine marker-positive carcinoma. Re-evaluation of initial biopsy demonstrated positivity for both PSA and neuroendocrine markers, indicating pre-existing neuroendocrine differentiation."

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

USE OF DEGARELIX IN DISSEMINATED INTRAVASCULAR COAGULATION SECONDARY TO PROSTATE CANCER. (WRMC 2026) - No abstract available

Genito-urinary Cancer • 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

Game changing session 3 : Game changing session: Randomized phase II trial of neoadjuvant degarelix with or without apalutamide prior to radical prostatectomy for unfavorable intermediate- and high-risk prostate cancer (EAU 2022) - No abstract available

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

ARNEO: A Randomized Phase II Trial of Neoadjuvant Degarelix with or Without Apalutamide Prior to Radical Prostatectomy for High-risk Prostate Cancer. (PubMed, Eur Urol) - "In high-risk PCa patients, neoadjuvant degarelix plus apalutamide prior to RP results in a significantly improved pathological response (MRD and RCB) compared with degarelix alone. Our trial results provide a solid hypothesis-generating basis for neoadjuvant phase 3 trials, which are powered to detect differences in long-term oncological outcome following neoadjuvant androgen receptor signaling inhibitor therapy."

Journal • P2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • PTEN

GETUG-AFU 22 Phase II Randomized Trial Evaluating Outcomes of Post-Operative Immediate Salvage Radiation Therapy with or without ADT for Patients with Persistently Elevated PSA Level (ASTRO 2022) - "Materials/ RP patients with nonmetastatic PCa on conventional preoperative imaging, and with a post-RP PSA level between 0.2 and 2 ng/mL were randomized (1:1) to iSRT alone (iSRT arm) or 6 months of ADT (degarelix) with iSRT (iSRT+ADT arm)... Despite the lack of differences in terms of EFS between the two arms, this study demonstrated that iSRT+ADT improved MFS without impaired quality-of-life for patients with persistently elevated PSA after RP."

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

Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial. (PubMed, Lancet) - P3 | "Compared with adding 6 months of ADT, adding 24 months of ADT improved metastasis-free survival in people receiving postoperative radiotherapy. For individuals who can accept the additional duration of adverse effects, long-course ADT should be offered with postoperative radiotherapy."

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

Adding 6 months of androgen deprivation therapy to postoperative radiotherapy for prostate cancer: a comparison of short-course versus no androgen deprivation therapy in the RADICALS-HD randomised controlled trial. (PubMed, Lancet) - P3 | "Metastatic disease is uncommon following postoperative bed radiotherapy after radical prostatectomy. Adding 6 months of ADT to this radiotherapy did not improve metastasis-free survival compared with no ADT. These findings do not support the use of short-course ADT with postoperative radiotherapy in this patient population."

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

Irradiation plus long-term adjuvant androgen deprivation with GnRH antagonist vs. GnRH agonist in patients with very high risk localized or locally advanced prostate cancer: The EORTC GUCG-1414 phase III PEGASUS randomized trial (EMUC 2024) - "Conclusions In patients with very high-risk prostate cancer treated with EBRT and long-term ADT, GnRH antagonist failed to demonstrate a superiority over LHRH agonists in achieving a PSA nadir <0.1ng/mL within 6 months after EBRT, a prognostic factor of long-term outcome. In patients with preexisting cardiovascular disease at baseline, a lower rate of further CVEs and treatment-related deaths was observed with degarelix."

Clinical • Metastases • P3 data • Cardiovascular • Genito-urinary Cancer • Infectious Disease • Nephrology • Oncology • Prostate Cancer • Solid Tumor

Sex-dependent endocrine and cellular effects of the GnRH antagonist degarelix in rabbits and cell models. (PubMed, Am J Transl Res) - "This study systematically demonstrates that degarelix exhibits concentration-dependent, sexually dimorphic, and tissue-specific effects in the regulation of reproductive endocrine functions, as well as direct actions on non-pituitary cells. Furthermore, its direct regulation of non-pituitary cells does not depend on changes in GnRHR protein abundance. These findings provide insight into the mechanisms underlying the antagonistic effects of GnRH and lay a theoretical foundation for the personalized application of degarelix in both experimental and clinical settings."

Journal • Preclinical • Endocrine Disorders • FSHB

A novel model to study the impact of gender-affirming therapy on bone in young male mice. (PubMed, J Bone Miner Res) - "Four-week-old male mice were treated with the gonadotropin-releasing hormone analogue degarelix (DGX) for pharmacological puberty suppression...Subsequent low-dose E2 administration reduced bone resorption, stimulated bone formation, and prevented the increase in bone marrow adiposity. In summary, we established and validated a mouse model that accurately mimics gender-affirming therapy initiated during early puberty and enables the study of its effects on bone."

Journal • Preclinical • Obesity

APEX: Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial primary completion date: Jan 2026 ➔ Jan 2027

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

A Study of BMS986365 in Combination With Degarelix in People With Prostate Cancer (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center

New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

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 | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • CD34

Phase II Trial of PSA Response-based Androgen Deprivation Therapy and Nodal Coverage for Prostate Cancer Early Salvage Radiotherapy (RANGER) (clinicaltrials.gov) - P2 | N=68 | Recruiting | Sponsor: University of Texas Southwestern Medical Center

New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Final Results of the Randomised Phase 2 Trial of Neoadjuvant Degarelix with or Without Apalutamide Prior to Radical Prostatectomy for High-risk Prostate Cancer (ARNEO). (PubMed, Eur Urol Oncol) - "At 3-yr follow-up, no differences were seen in the 3-yr BCR rate or BCR-FS between patients treated with neoadjuvant DEG + APA and those treated with DEG + PBO. Achieving MRD was not predictive of better outcomes, whereas ypT2 and specimen-confined disease were strongly associated with improved BCR-FS and MFS. Quality of life remained similar between groups at all time points."

Journal • P2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urinary Incontinence • Urology