apalutamide / Generic mfg. - LARVOL DELTA

Tolerability of Doublet Therapy in Elderly (≥75 years) with Metastatic Prostate Cancer: A Single Centre Experience study (SIOG 2025) - "ARPIs used included 44% darolutamide , 31% abiraterone, 11% enzalutamide and 14% apalutamide. These findings highlight the feasibility and tolerability of doublet therapy in elderly patients, emphasising its role in improving outcomes in a real-world setting."

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

Metabolic dysfunction following treatment for prostate cancer (SIOG 2025) - "Odds of metabolic condition within 12 months following ADT+ARSI by age and ARSI*ConditionAge GroupsARSIAbirateroneApalutamideDarolutamideEnzalutamideHypertension65<801.48 (1.30, 1.68)1.53 (1.12, 2.09)1.54 (1.19, 1.99)3.23 (2.77, 3.76)≥801.92 (1.68, 2.21)1.87 (1.34, 2.59)2.56 (1.94, 3.36)3.81 (3.25, 4.46)Type 2 Diabetes65<801.40 (1.23, 1.59)1.30 (0.94, 1.80)1.19 (0.89, 1.58)1.15 (0.98, 1.35)≥801.40 (1.22, 1.61)1.33 (0.94, 1.89)1.58 (1.17, 2.13)0.98 (0.83, 1.16)Dyslipidemia65<801.49 (1.33, 1.68)1.34 (1.01, 1.69)1.56 (1.23, 1.99)1.64 (1.41, 1.92)≥801.70 (1.50, 1.92)1.70 (1.27, 2.27)2.39 (1.84, 3.09)1.86 (1.58, 2.18)Obesity65<800.89 (0.78, 0.94)0.95 (0.75, 1.18)1.04 (0.84, 1.31)0.83 (0.73, 0.93)≥800.54 (0.51, 0.62)0.53 (0.40, 0.69)0.88 (0.69, 1.14)0.48 (0.42, 0.55)* All odds compare the group named vs persons 18<65. MetS and its component conditions are a real outcome following concomitant ADT and ARSI therapy and the odds of experiencing a new comorbidity..."

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

Real-world efficacy and safety of apalutamide in elderly and frail patients with metastatic castration-sensitive prostate cancer (SIOG 2025) - "APA demonstrated consistent efficacy and safety across elderly and frail mCSPC pts, underrepresented in clinical trials. A trend toward delayed deep PSA responses in frail pts was observed but did not impact early survival outcomes."

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

Tolerability of Doublet Therapy in Elderly (≥75 years) with Metastatic Prostate Cancer: A Single Centre Experience study (SIOG 2025) - "ARPIs used included 44% darolutamide , 31% abiraterone, 11% enzalutamide and 14% apalutamide. These findings highlight the feasibility and tolerability of doublet therapy in elderly patients, emphasising its role in improving outcomes in a real-world setting."

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

Real-world efficacy and safety of apalutamide in elderly and frail patients with metastatic castration-sensitive prostate cancer (SIOG 2025) - "APA demonstrated consistent efficacy and safety across elderly and frail mCSPC pts, underrepresented in clinical trials. A trend toward delayed deep PSA responses in frail pts was observed but did not impact early survival outcomes."

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

Metabolic dysfunction following treatment for prostate cancer (SIOG 2025) - "Odds of metabolic condition within 12 months following ADT+ARSI by age and ARSI*ConditionAge GroupsARSIAbirateroneApalutamideDarolutamideEnzalutamideHypertension65<801.48 (1.30, 1.68)1.53 (1.12, 2.09)1.54 (1.19, 1.99)3.23 (2.77, 3.76)≥801.92 (1.68, 2.21)1.87 (1.34, 2.59)2.56 (1.94, 3.36)3.81 (3.25, 4.46)Type 2 Diabetes65<801.40 (1.23, 1.59)1.30 (0.94, 1.80)1.19 (0.89, 1.58)1.15 (0.98, 1.35)≥801.40 (1.22, 1.61)1.33 (0.94, 1.89)1.58 (1.17, 2.13)0.98 (0.83, 1.16)Dyslipidemia65<801.49 (1.33, 1.68)1.34 (1.01, 1.69)1.56 (1.23, 1.99)1.64 (1.41, 1.92)≥801.70 (1.50, 1.92)1.70 (1.27, 2.27)2.39 (1.84, 3.09)1.86 (1.58, 2.18)Obesity65<800.89 (0.78, 0.94)0.95 (0.75, 1.18)1.04 (0.84, 1.31)0.83 (0.73, 0.93)≥800.54 (0.51, 0.62)0.53 (0.40, 0.69)0.88 (0.69, 1.14)0.48 (0.42, 0.55)* All odds compare the group named vs persons 18<65. MetS and its component conditions are a real outcome following concomitant ADT and ARSI therapy and the odds of experiencing a new comorbidity..."

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

Tolerability of Doublet Therapy in Elderly (≥75 years) with Metastatic Prostate Cancer: A Single Centre Experience study (SIOG 2025) - "ARPIs used included 44% darolutamide , 31% abiraterone, 11% enzalutamide and 14% apalutamide. These findings highlight the feasibility and tolerability of doublet therapy in elderly patients, emphasising its role in improving outcomes in a real-world setting."

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

Real-world efficacy and safety of apalutamide in elderly and frail patients with metastatic castration-sensitive prostate cancer (SIOG 2025) - "APA demonstrated consistent efficacy and safety across elderly and frail mCSPC pts, underrepresented in clinical trials. A trend toward delayed deep PSA responses in frail pts was observed but did not impact early survival outcomes."

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

Metabolic dysfunction following treatment for prostate cancer (SIOG 2025) - "Odds of metabolic condition within 12 months following ADT+ARSI by age and ARSI*ConditionAge GroupsARSIAbirateroneApalutamideDarolutamideEnzalutamideHypertension65<801.48 (1.30, 1.68)1.53 (1.12, 2.09)1.54 (1.19, 1.99)3.23 (2.77, 3.76)≥801.92 (1.68, 2.21)1.87 (1.34, 2.59)2.56 (1.94, 3.36)3.81 (3.25, 4.46)Type 2 Diabetes65<801.40 (1.23, 1.59)1.30 (0.94, 1.80)1.19 (0.89, 1.58)1.15 (0.98, 1.35)≥801.40 (1.22, 1.61)1.33 (0.94, 1.89)1.58 (1.17, 2.13)0.98 (0.83, 1.16)Dyslipidemia65<801.49 (1.33, 1.68)1.34 (1.01, 1.69)1.56 (1.23, 1.99)1.64 (1.41, 1.92)≥801.70 (1.50, 1.92)1.70 (1.27, 2.27)2.39 (1.84, 3.09)1.86 (1.58, 2.18)Obesity65<800.89 (0.78, 0.94)0.95 (0.75, 1.18)1.04 (0.84, 1.31)0.83 (0.73, 0.93)≥800.54 (0.51, 0.62)0.53 (0.40, 0.69)0.88 (0.69, 1.14)0.48 (0.42, 0.55)* All odds compare the group named vs persons 18<65. MetS and its component conditions are a real outcome following concomitant ADT and ARSI therapy and the odds of experiencing a new comorbidity..."

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

Metabolic dysfunction following treatment for prostate cancer (SIOG 2025) - "Odds of metabolic condition within 12 months following ADT+ARSI by age and ARSI*ConditionAge GroupsARSIAbirateroneApalutamideDarolutamideEnzalutamideHypertension65<801.48 (1.30, 1.68)1.53 (1.12, 2.09)1.54 (1.19, 1.99)3.23 (2.77, 3.76)≥801.92 (1.68, 2.21)1.87 (1.34, 2.59)2.56 (1.94, 3.36)3.81 (3.25, 4.46)Type 2 Diabetes65<801.40 (1.23, 1.59)1.30 (0.94, 1.80)1.19 (0.89, 1.58)1.15 (0.98, 1.35)≥801.40 (1.22, 1.61)1.33 (0.94, 1.89)1.58 (1.17, 2.13)0.98 (0.83, 1.16)Dyslipidemia65<801.49 (1.33, 1.68)1.34 (1.01, 1.69)1.56 (1.23, 1.99)1.64 (1.41, 1.92)≥801.70 (1.50, 1.92)1.70 (1.27, 2.27)2.39 (1.84, 3.09)1.86 (1.58, 2.18)Obesity65<800.89 (0.78, 0.94)0.95 (0.75, 1.18)1.04 (0.84, 1.31)0.83 (0.73, 0.93)≥800.54 (0.51, 0.62)0.53 (0.40, 0.69)0.88 (0.69, 1.14)0.48 (0.42, 0.55)* All odds compare the group named vs persons 18<65. MetS and its component conditions are a real outcome following concomitant ADT and ARSI therapy and the odds of experiencing a new comorbidity..."

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

Metabolic dysfunction following treatment for prostate cancer (SIOG 2025) - "Odds of metabolic condition within 12 months following ADT+ARSI by age and ARSI*ConditionAge GroupsARSIAbirateroneApalutamideDarolutamideEnzalutamideHypertension65<801.48 (1.30, 1.68)1.53 (1.12, 2.09)1.54 (1.19, 1.99)3.23 (2.77, 3.76)≥801.92 (1.68, 2.21)1.87 (1.34, 2.59)2.56 (1.94, 3.36)3.81 (3.25, 4.46)Type 2 Diabetes65<801.40 (1.23, 1.59)1.30 (0.94, 1.80)1.19 (0.89, 1.58)1.15 (0.98, 1.35)≥801.40 (1.22, 1.61)1.33 (0.94, 1.89)1.58 (1.17, 2.13)0.98 (0.83, 1.16)Dyslipidemia65<801.49 (1.33, 1.68)1.34 (1.01, 1.69)1.56 (1.23, 1.99)1.64 (1.41, 1.92)≥801.70 (1.50, 1.92)1.70 (1.27, 2.27)2.39 (1.84, 3.09)1.86 (1.58, 2.18)Obesity65<800.89 (0.78, 0.94)0.95 (0.75, 1.18)1.04 (0.84, 1.31)0.83 (0.73, 0.93)≥800.54 (0.51, 0.62)0.53 (0.40, 0.69)0.88 (0.69, 1.14)0.48 (0.42, 0.55)* All odds compare the group named vs persons 18<65. MetS and its component conditions are a real outcome following concomitant ADT and ARSI therapy and the odds of experiencing a new comorbidity..."

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

Real-world efficacy and safety of apalutamide in elderly and frail patients with metastatic castration-sensitive prostate cancer (SIOG 2025) - "APA demonstrated consistent efficacy and safety across elderly and frail mCSPC pts, underrepresented in clinical trials. A trend toward delayed deep PSA responses in frail pts was observed but did not impact early survival outcomes."

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

Tolerability of Doublet Therapy in Elderly (≥75 years) with Metastatic Prostate Cancer: A Single Centre Experience study (SIOG 2025) - "ARPIs used included 44% darolutamide , 31% abiraterone, 11% enzalutamide and 14% apalutamide. These findings highlight the feasibility and tolerability of doublet therapy in elderly patients, emphasising its role in improving outcomes in a real-world setting."

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

Impact of Metastatic Hormone-sensitive Prostate Cancer Treatments on Health-related Quality of Life: A Systematic Review and Network Meta-analysis. (PubMed, Eur Urol Focus) - "HRQoL outcomes differ across treatment strategies for mHSPC. At 12 mo, ADT + abiraterone yielded the most favourable HRQoL profile."

HEOR • Journal • Retrospective data • Review • Fatigue • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Pain • Prostate Cancer • Solid Tumor

A multicenter, single-arm, phase II trial of androgen deprivation therapy in combination with apalutamide in patients with high risk of recurrence after radical prostatectomy (ARES study) (ESMO Asia 2025) - P2 | "Adjuvant apalutamide (240 mg/day) plus ADT demonstrated promising efficacy (100% 6-month bPFS) and manageable safety in high-risk LPC patients post-RP. These interim results support further investigation of this regimen as a potential strategy to reduce recurrence in this population."

Clinical • Combination therapy • P2 data • Oncology • Prostate Cancer

Short-term neoadjuvant apalutamide plus androgen deprivation therapy in high-risk prostate cancer: Early outcomes from a retrospective cohort (ESMO Asia 2025) - "Early results suggest that short-term apalutamide combined with ADT is highly effective in high-risk, localized prostate cancer, demonstrating a 25% pCR rate and 100% biochemical survival at 18 months in patients with undetectable post-prostatectomy PSA. Further studies with larger samples, alongside mpMRI and molecular profiling, are ongoing to identify predictors of exceptional response and resistance."

Retrospective data • Genito-urinary 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

Evaluation of circulating tumor DNA-based genomic alterations in patients with mCSPC treated with Apalutamide: CUARTET study in Japan (ESMO Asia 2025) - P4 | "CUARTET study highlighted consistent efficacy and safety of Apa in Japanese patients with mCSPC. The presence of baseline ctDNA was associated with shorter time to CRPC and OS. Some GAs may cause early progression on treatment with AR pathway inhibitors that need to be further clarified in future studies."

Circulating tumor DNA • Clinical • Castration-Resistant Prostate Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer

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

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

A Study to Learn About Two Medicines (Apalutamide and Enzalutamide) in People With Metastatic Castration-sensitive Prostate Cancer (mCSPC) (clinicaltrials.gov) - P=N/A | N=1300 | Completed | Sponsor: Pfizer | Recruiting ➔ Completed

Real-world evidence • Trial completion • Genito-urinary Cancer • Hormone Sensitive Prostate 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

Response to Letter to the Editor Regarding: ’Overall Survival with Apalutamide Versus Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer’. (PubMed, Adv Ther) - No abstract available

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

Apalutamide-induced rash and relative dose intensity in metastatic castration-sensitive prostate cancer: a multicenter Japanese cohort study. (PubMed, Transl Androl Urol) - "Advanced age and low BMI are significant risk factors for apalutamide-induced rash in patients with mCSPC. Importantly, decreased RDI resulting from dose reduction or interruption did not compromise PFS, implying that timely dose modification may be a safe and effective strategy to manage adverse events without impairing oncological efficacy."

Journal • Castration-Resistant Prostate Cancer • Dermatology • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor