Nubeqa (darolutamide) / Bayer, Orion Corp - LARVOL DELTA

Darolutamide combined with androgen deprivation therapy and prostate arterial docetaxel infusion for locally advanced or oligometastatic hormone-sensitive prostate cancer: A Trial in Progress(DAPLOM Study) (ESMO Asia 2025) - P2 | "With a historical pCR+MRD rate of 5% and a target of 40%, 60 patients yield 80% power (one-sided α = 0.05). Screening/enrollment: Q2–Q4 2025; neoadjuvant therapy complete by Q1 2026; surgery in Q2 2026; final analyses by Q4 2026."

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

Efficacy and safety of darolutamide-based doublet and triplet therapies in metastatic hormone-sensitive prostate cancer a retrospective study (ESMO Asia 2025) - "Background: Darolutamide is the only next-generation androgen receptor inhibitor (ARi) approved for both doublet (ADT + ARi) and triplet (ADT + ARi + docetaxel) therapy in metastatic hormone-sensitive prostate cancer (mHSPC). Darolutamide-based doublet and triplet therapies demonstrated promising efficacy and tolerability in treating mHSPC. Notably, this is the first real-world study in China evaluating both treatment strategies. These findings support their clinical utility and warrant further validation in larger prospective studies."

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

A real-world study of darolutamide combined with docetaxel in patients with metastatic hormone-sensitive prostate cancer in Hainan, China (ESMO Asia 2025) - "Hainan-based prostate cancer pts exhibit more severe metastatic baseline conditions and higher PSA levels compared to darolutamide triplet studies. Docetaxel combined with darolutamide and ADT achieved rapid PSA response, suggesting favorable outcome. The treatment is well-tolerated, allowing for dose adjustments based on individual circumstances."

Clinical • Metastases • Real-world • Real-world evidence • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Treatment intensification in metastatic hormone sensitive prostate cancer (mHSPC), real-world adoption of combination therapies in Australia and Asia (ESMO Asia 2025) - "Background: The addition of androgen receptor pathway inhibitors (ARPI) with or without docetaxel (DOC) to androgen deprivation therapy (ADT) has significantly improved outcomes in mHSPC...In Asia, the most common ARPI was apalutamide (41%) and abiraterone (41%). In Australia, darolutamide (30%) and enzalutamide (30%) were most used... Our real-world data demonstrates improved adoption of standard of care therapy since January 2023 in Australia and Asia. The use of ADT alone may reflect differences in the real-world population. However, the improvement seen in time to CRPC with combination therapy demonstrates the survival gains that can be achieved in the real-world setting."

Clinical • Combination therapy • Metastases • Real-world • Real-world evidence • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Darolutamide-based triple therapy combined with PSMA PET/CT-guided focal treatment in patients with prostate cancer: A Multicenter retrospective study (ESMO Asia 2025) - "Background: Darolutamide, a novel androgen receptor inhibitor, improved survival in mHSPC when combined with ADT and docetaxel in the ARASENS trial. In mHSPC patients, darolutamide-based triple therapy combined with PSMA PET/CT-guided focal treatment achieved high disease control rates with favorable safety, highlighting the advantages of a multimodal precision treatment approach. These findings warrant further validation in prospective studies."

Retrospective data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Darolutamide + androgen-deprivation therapy in Chinese patients with high-risk non-metastatic castration-resistant prostate cancer from the China post-approval commitment study (ESMO Asia 2025) - "DARO + ADT offers a favorable benefit-risk profile in Chinese pts with nmCRPC, demonstrating effective treatment outcomes that are consistent with ARAMIS while maintaining a robust safety profile."

Clinical • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Efficacy and safety of Darolutamide combined with trans-arterial chemoperfusion by Docetaxel in metastatic hormone-sensitive prostate cancer (ESMO Asia 2025) - "In this pilot cohort, the combination regimen of trans-arterial docetaxel chemoperfusionwith darolutamide and ADT demonstrated rapid and profound PSA suppression, significant improvements in voiding parameters, and a manageable safety profile in patients with mHSPC."

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

Safety and efficacy of darolutamide in combination with androgen-deprivation therapy for prostate cancer: a systematic review and meta-analysis. (PubMed, Ann Med Surg (Lond)) - "Darolutamide + ADT improves outcomes for PC patients but presents safety concerns, including bone fractures and hypertension. Further trials are needed for optimal patient selection and long-term management."

Journal • Retrospective data • Cardiovascular • Castration-Resistant Prostate Cancer • CNS Disorders • Fatigue • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Hypertension • Mental Retardation • Musculoskeletal Diseases • Oncology • Pain • Prostate Cancer • Psychiatry • Solid Tumor

Therapeutic Advances in Metastatic Prostate Cancer: A Journey from Standard of Care to New Emerging Treatment. (PubMed, Int J Mol Sci) - "We detail the evidence supporting the integration of systemic agents like abiraterone, enzalutamide, and darolutamide into both hormone-sensitive and castration-resistant settings. Furthermore, we highlight the expanding role of radioligand therapies, including radium-223 and Lutetium-177-labeled PSMA-617 (Lu-PSMA-617), as well as the growing impact of PARP inhibitors in genomically selected patients. The emergence of theranostic strategies and next-generation sequencing has paved the way for personalized treatment algorithms, moving toward a truly precision oncology model in PCa. This comprehensive review synthesizes current therapeutic strategies, clinical trial evidence, and future directions aimed at optimizing outcomes and quality of life for patients with advanced prostate cancer."

Journal • Review • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • PTEN • TP53

Unexpected Fatal Pneumocystis Jirovecii Pneumonia During Triplet Therapy for Hormone-Sensitive Prostate Cancer. (PubMed, Respirol Case Rep) - "A 75-year-old man with low-volume metastatic hormone-sensitive prostate cancer (mHSPC) received triplet therapy with relugolix, darolutamide and docetaxel...Despite appropriate trimethoprim-sulfamethoxazole and corticosteroid therapy, he died of respiratory failure ~10 days after symptom onset. This case highlights an underrecognized risk of PJP during triplet therapy for mHSPC. Prophylaxis should be considered in select high-risk patients, including elderly individuals or those with metabolic comorbidities."

Journal • Anorexia • Diabetes • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Infectious Disease • Metabolic Disorders • Oncology • Pneumonia • Prostate Cancer • Respiratory Diseases • Solid Tumor

PETRANHA: Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer (clinicaltrials.gov) - P1/2 | N=174 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Apalutamide is linked to fewer CNS-related conditions in patients with nmCRPC (Urology Times) - "...Research presented at the 2025 Society of Urology Oncology Annual Meeting....The investigators reported that new onset of CNS-related conditions was lower in patients in the apalutamide cohort at 12 months (apalutamide, 25.7%, darolutamide, 31.4%, enzalutamide, 40.8%) and 24 months (apalutamide: 46.6%, darolutamide: 54.6%, enzalutamide: 59.7%) post index. The median time-to-new onset of CNS-related conditions was 29.2 months in the apalutamide cohort vs 21.3 months in the darolutamide cohort and 18.1 months in the enzalutamide cohort."

Retrospective data • Castration-Resistant Prostate Cancer

Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer (clinicaltrials.gov) - P2 | N=25 | Active, not recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2027 ➔ Nov 2028 | Trial primary completion date: Jan 2027 ➔ Nov 2028

Enrollment closed • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

An Eco-Friendly and Quality-by-Design Optimized Synchronous Spectrofluorescence Method for the Simultaneous Determination of Cleaning Residues of Anticancer Drugs Darolutamide and Enzalutamide From Manufacturing Surfaces. (PubMed, Luminescence) - "The method was evaluated for analytical greenness metrics using Analytical Green Star Area and Multicolor Assessment tools. This study represents the first report of a synchronous fluorimetric method for this drug pair and its usage in the pharmaceutical cleaning process."

Journal • Oncology

A phase II neoadjuvant clinical trial of the androgen receptor inhibitor darolutamide in early-stage androgen receptor positive (AR+) triple-negative breast cancer (NCT 07016399) (SABCS 2025) - P2 | "Treatment with the AR inhibitor enzalutamide has been shown to reduce Ki-67 levels in luminal AR tumors. Exploratory objectives include assessing changes in ctDNA levels while undergoing neoadjuvant therapy for TNBC as well as investigating additional AR characteristics and mechanisms of resistance to AR inhibitors. This study is open at Vanderbilt University Medical Center and will be opening at 6 additional sites."

Clinical • IO biomarker • P2 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • AR • ER

Efficacy and safety of treatments for metastatic castration-sensitive prostate cancer: A comprehensive network meta-analysis including final ARANOTE data. (PubMed, Prostate Cancer Prostatic Dis) - "This NMA supports the superior efficacy of ARPI combinations against ADT monotherapy, for both OS and PFS. While DAR + ADT demonstrated comparable efficacy to other doublet combinations, it offered a superior safety profile, making it an effective and safe option for managing patients with mCSPC."

Journal • Retrospective data • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea (clinicaltrials.gov) - P=N/A | N=600 | Recruiting | Sponsor: Bayer | Trial completion date: Jun 2026 ➔ Jun 2028 | Trial primary completion date: Mar 2026 ➔ Mar 2028

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

Orion to receive €180m milestone payment from Bayer for Nubeqa (Investing.com) - "Orion also revised its operating profit (EBIT) forecast to €590-670 million, increased from the previous range of €410-490 million."

Commercial • Castration-Resistant Prostate Cancer • Hormone Sensitive Prostate Cancer

Rapid Eradication of Extensive Spinal Metastases in a Prostate-Cancer Patient Taking Androgen-deprivation Therapy, Chemotherapy, and Oral Recombinant Methioninase on a Low-Methionine Diet. (PubMed, Anticancer Res) - "The patient achieved an apparent complete response of prostate-cancer spinal metastases after treatment with ADT, chemotherapy, and methionine restriction. Further studies, including controlled clinical trials are necessary to validate this new paradigm of treatment for prostate-cancer bone metastases."

Clinical • Journal • CNS Disorders • Genito-urinary Cancer • Oncology • Prostate Cancer • Psychiatry • Solid Tumor

Abemaciclib plus abiraterone in patients with metastatic castration-resistant prostate cancer (CYCLONE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. (PubMed, Lancet Oncol) - P2/3 | "Dual inhibition of CDK4 and CDK6 and the androgen receptor pathway with abemaciclib plus abiraterone did not improve radiographic progression-free survival compared with abiraterone alone in the CYCLONE 2 study population with mCRPC. Safety of the combination was consistent with the previously reported safety of the individual drugs. Additional research is required to identify effective combination therapies for patients with mCRPC, especially in those presenting with adverse prognostic characteristics."

Clinical • Journal • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hematological Disorders • Hormone Sensitive Prostate Cancer • Interstitial Lung Disease • Neutropenia • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor • AR • CDK6

TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC) (clinicaltrials.gov) - P1/2 | N=203 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Daiichi Sankyo

New P1 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Real-World Clinical Outcomes of Darolutamide in Older Patients With Non-metastatic Castration-Resistant Prostate Cancer: A Multi-institutional Comparative Analysis of Efficacy and Tolerability (Cureus) - "Twenty-five patients (69.4%) were aged ≥75 years, and 13 patients (36.1%) were aged ≥80 years. The overall PSA response rates were 88.9% for a 50% decline and 69.4% for a 90% decline. PSA response did not differ between age groups for either 75- or 80-year thresholds. No significant differences were observed in PFS or OS between subgroups."

Real-world evidence • Castration-Resistant Prostate Cancer

ProstACT Global: A phase 3 study of Lutetium (Lu177) rosopatamab tetraxetan plus SoC vs SoC alone in patients with metastatic castration-resistant prostate cancer (SUO 2025) - P3 | "In Part 1, patients are divided into 3 groups (n=10 each) to receive 2 single intravenous injections of 76 mCi each, 14d apart, of 177 Lu-rosopatamab with standard of care (SoC) combinations with abiraterone, enzalutamide, or docetaxel to characterize biodistribution & safety profiles of 177 Lu-rosopatamab + SoC combinations...Eligible patients must have PSMA-expressing mCRPC and have experienced disease progression on a minimum 12w prior therapy on their 1 st ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide) in metastatic castration-sensitive PC, non-metastatic CRPC, or mCRPC settings...This study is sponsored by Telix Pharmaceuticals and is currently enrolling in Part 1. ClinicalTrials.gov ID: NCT06520345 "

Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

PSMACare trial-in-progress: a phase II trial of [177Lu]Lu-PSMA-617 with or without ARPI in patients with PSMA-positive non-metastatic castration-resistant prostate cancer (ESMO 2025) - P2 | "Participants (N = ∼120) will be randomized 1:1 to receive 177 Lu-PSMA-617 (7.4 GBq q6w, up to 6 cycles) or 177 Lu-PSMA-617 + ARPI (apalutamide, darolutamide or enzalutamide); ADT must be ongoing in both arms. Legal entity responsible for the study Novartis. Funding Novartis."

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