apalutamide / Generic mfg. - LARVOL DELTA

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

Risk Factors for Drug-Induced Severe Cutaneous Adverse Reactions: A Real-World Pharmacovigilance Analysis. (PubMed, J Dermatol) - "Logistic regression identified older age, male sex, and 114 drugs as independent risk factors for drug-induced SCARs, including amlodipine (adjusted ROR = 2.89), bisoprolol (adjusted ROR = 3.52), and losartan (adjusted ROR = 2.77). In the non-Asian population, the strongest signals were observed for allopurinol (adjusted ROR = 98.52), cefotaxime (adjusted ROR = 68.52), and lamotrigine (adjusted ROR = 38.59), whereas apalutamide (adjusted ROR = 14.57), ipilimumab (adjusted ROR = 3.24), and acetylsalicylic acid (adjusted ROR = 2.85) were detected only in Asians...The Asian population had a significantly shorter TTO compared to the non-Asian population (p < 0.001). This study uses FAERS data to analyze risk factors for drug-induced SCARs, emphasizing early identification and discontinuation of suspected drugs to enhance patient safety."

Adverse events • Journal • Real-world evidence • Immunology

PSMA expression assessed by [18F]PSMA-1007 PET/CT imaging in metastatic hormone-sensitive prostate cancer patients treated with apalutamide. (PubMed, Cancer Imaging) - No abstract available

Journal • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • FOLH1

Androgen deprivation therapy with apalutamide in the treatment of metastatic castration-sensitive prostate cancer: the systematic review of its effectiveness and applicability for Asian men in the targeted investigational treatment analysis of novel anti-androgen (TITAN) trial. (PubMed, Int Urol Nephrol) - "Asian subpopulation efficacy with apalutamide + ADT is directionally consistent with TITAN overall, with higher rash frequency that is generally manageable. Small subpopulation size and overlapping publications limit precision; regionally representative real‑world studies are needed."

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

Global inequities in the access to systemic prostate cancer therapies: A comprehensive global analysis and implications (EMUC 2025) - "While HICs reported near-universal access to most approved agents, access rates declined sharply in UMICs and LICs, especially for newer agents such as abiraterone, enzalutamide, apalutamide, and olaparib. Conclusions Persistent global inequities in access to and affordability of approved systemic therapies for prostate cancer remain, especially in LICs and specific regions. Addressing these disparities requires urgent, coordinated policy action and innovative financing to ensure equitable access to life-saving therapies for all patients."

Clinical • Genito-urinary Cancer • Oncology • Prostate Cancer • 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

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

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

PSMANDARPI: PHASE II STUDY OF 177LU-PSMA-617 PLUS ANDROGEN RECEPTOR PATHWAY INHIBITOR VERSUS 177LU-PSMA-617 AS FIRST-LINE TREATMENT OF PROSTATE-SPECIFIC MEMBRANE ANTIGEN-POSITIVE PROGRESSIVE METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (SUO 2025) - P2 | "Randomization will be stratified by type of prior ARPI (abiraterone vs other [enzalutamide, apalutamide, or darolutamide]) and by setting of prior ARPI (mHSPC without docetaxel vs mHSPC with docetaxel vs others [BCR-nmHSPC or nmCRPC setting]). The expected study duration is 42 months. Clinical Trial Registry Number NCT06894511 "

Clinical • Metastases • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • FOLH1

French recommendations from the AFU Cancer Committee for prostate cancer 2025 Summary of changes. (PubMed, Fr J Urol) - "This 2025 summary of changes of French recommendations on PCa should help physicians to stay up-to-date with recent evolutions and aim to improve the management of PCa patients."

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

PRO-MIND: Quality of Life, Functional and Cognitive Outcomes in Patients With Metastatic Hormone-Sensitive Prostate Cancer (clinicaltrials.gov) - P=N/A | N=102 | Recruiting | Sponsor: Ankara Etlik City Hospital | Not yet recruiting ➔ Recruiting

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

PRESTO: A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer (clinicaltrials.gov) - P3 | N=504 | Completed | Sponsor: Alliance Foundation Trials, LLC. | Active, not recruiting ➔ Completed | Trial completion date: Jan 2026 ➔ Jun 2025

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

The Impact of Early Modification of Upfront Androgen Receptor Signaling Inhibitors on Survival Outcomes in Metastatic Hormone-Sensitive Prostate Cancer. (PubMed, Prostate) - "Early withdrawal of initial upfront ARSI was associated with poor CRPC-FS and PFS2 among mHSPC patients. Maximizing the effectiveness of first-line treatment requires optimal management of ARSI therapy."

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

Matching-adjusted Indirect Comparison (MAIC) between enzalutamide (ENZA) and apalutamide (APA) with Androgen-Deprivation Therapy (ADT) in Metastatic Hormone-sensitive Prostate Cancer (mHSPC) (EMUC 2025) - P3 | "The following EMs were selected based on a literature review, expert consultations, and statistical analysis: age, visceral disease, initial diagnosis (de novo/recurrent), disease volume, Gleason score, race, region, and prior docetaxel use. Conclusions The MAIC showed comparable efficacy for patients treated with ENZA + ADT vs those treated with APA + ADT. While differences were seen in rPFS, no significant differences were found in OS and TTPP."

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